data stringlengths 198 8.94k | criteria stringlengths 30 16.5k | __index_level_0__ int64 0 22.4k |
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Study Objectives
The purpose of this study is to determine whether Vitamin D supplementation reduces the symptoms of muscle stiffness and joint tenderness that some patients may develop after starting therapy with Anastrozole for breast cancer.
Conditions: Breast Neoplasms
Intervention / Treatment:
DIETARY_SUPPLEMENT... | Inclusion Criteria
* Women with a diagnosis of hormone receptor positive invasive breast cancer (Stage I-IIIB) or ductal carcinoma in situ (DCIS)
* Postmenopausal status
* Completed at least 8 weeks of anastrozole as adjuvant therapy prior to study entry
* Completed systemic chemotherapy and radiation treatments when ... | 12,084 |
Study Objectives
The purpose of this study is to determine if vitamin D will improve insulin resistance, inflammation, and overall well-being in women with PCOS.
Conditions: Polycystic Ovary Syndrome
Intervention / Treatment:
DIETARY_SUPPLEMENT: Vitamin D, DRUG: Placebo
Location: United States
Study Design and Phas... | Inclusion Criteria:
* Diagnosis of PCOS based on:
* Eight or fewer menstrual periods per year or spontaneous intermenstrual periods of greater than or equal to 45 days, and
* Elevated testosterone levels
Exclusion Criteria:
* Current Pregnancy or Nursing
* Elevated calcium
* Kidney Stones or kidney disease
* Cu... | 17,503 |
Study Objectives
The goal of the study is to learn about patients' knowledge of their medications in an outpatient acute care setting (such as the M. D. Anderson Emergency Center) and to learn about any clinical factors that affect patients' knowledge of their medications.
Conditions: Advanced Cancer
Intervention / T... | Inclusion Criteria:
* Patients admitted to the Emergency Center
* Patients must be able to read and write English
* Patients must agree to participate and sign informed consent
* Patients 16 years or above. (Age limit explained below)
* Patients must be able to complete the survey tool. They may have help from a careg... | 8,517 |
Study Objectives
The addition of RAD001, an mTOR inhibitor, to irinotecan and anti-EGFR antibody cetuximab may increase efficacy for patients with metastatic colorectal cancer who progressed on prior chemotherapy. This approach is biologically directed to overall target the cancer cell at multiple levels, and potential... | Inclusion Criteria:
* Histological or cytological proof of colon or rectal adenocarcinoma
* Measurable site of disease according to RECIST that has not been previously irradiated
* Must have metastatic colorectal cancer which progressed after first line chemotherapy +/- bevacizumab
* Blood sample collected within 21 d... | 10,210 |
Study Objectives
A study to determine the safety of CSC/ HTS-based combination drug therapy in subjects who have GBM that has recurred or progressed following prior radiation therapy and TMZ.
Conditions: Glioblastoma Multiforme
Intervention / Treatment:
DRUG: Combination Drug Therapy
Location: United States
Study D... | Inclusion Criteria:
Determined at pre-screening:
* A histological diagnosis of GBM [WHO grade IV].
* Subjects >=18 years
* Signed informed consent for tumor collection prior to initiation of any study-specific procedure. The patient or the patient's legal authorized representative must be able to provide written info... | 5,187 |
Study Objectives
The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen.
Conditions: Malignant Pleural Mesothelioma
Intervention / Treatment:
DRUG: NGR-h... | Inclusion Criteria:
* Age >= 18 years
* Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown
* Prior treatment with no more than one systemic pemetrexed-based chemotherapy regimen administered for advanced or metastatic disea... | 3,415 |
Study Objectives
This is an open-label, multicenter, Phase 1/2 study of the CTLA-4 antibody, tremelimumab, and the PD-L1 antibody, durvalumab (MEDI4736), in combination with the tumor microenvironment (TME) modulator poly-ICLC, a TLR3 agonist, in subjects with advanced, measurable, biopsy-accessible cancers.
Condition... | Inclusion Criteria:
* Subjects must have histologic confirmation of advanced, biopsy-accessible, measurable cancers of the following histologies:
* Non-viral-associated head and neck squamous cell carcinoma (HNSCC) or human papillomavirus (HPV)-associated HNSCC after failure of prior therapy
* Locally recurrent... | 6,289 |
Study Objectives
Pazopanib (Votrient) is registered for the treatment of patients with advanced renal cell carcinoma and patients with soft tissue sarcoma who have received prior chemotherapy. It is administered at a fixed oral dose of 800 mg once daily (OD) regardless of size, age and clinical condition. It is absorbe... | Inclusion Criteria:
* Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.
Note: informed consent may be obtained prior to start of the specified screening window.
Note: procedures conducted a... | 9,358 |
Study Objectives
This randomized, Phase III, double-blind, placebo-controlled study will evaluate the safety and efficacy of MetMAb (onartuzumab) in combination with Tarceva (erlotinib) compared with treatment with Tarceva alone in patients with incurable Met-positive non-small cell lung cancer (NSCLC). Patients will b... | Inclusion Criteria:
* Male or female, >= 18 years.
* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 <= age <= 1.
* Histologically confirmed incurable Stage IIIB/IV NSCLC tumor.
* Met-positive status and results of epidermal growth factor receptor (EGFR)-activating mutation testing.
... | 169 |
Study Objectives
Raltitrexed is a potent thymidylate synthase (TS) inhibitor. Conversely to 5-fluorouracil (5FU), raltitrexed can be administered safely in patients with cardiovascular disease, as well as in patients with dihydropyrimidine dehydrogenase deficit. Since raltitrexed is administered in 15-minutes infusion,... | Inclusion Criteria:
* performance status (ECOG-PS) of 0 or 1
* patient with histologically proven colorectal cancer with distant metastases
* measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* life expectancy > 12 months
* signed written informed consent
Exclusion Criteria:
* p... | 19,495 |
Study Objectives
To compare the difference between the ARIMIDEX group and the tamoxifen group in the incidence of abnormal endometrial histological findings arising after treatment has commenced.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Anastrozole (Arimidex), DRUG: Tamoxifen (Nolvadex), DRUG: Nolvad... | Inclusion Criteria:
* Patients eligible for entry into the main ATAC trial (1033IL/0029)
* Not received any previous tamoxifen, for whatever reason
* Not undergone a hysterectomy and do not have a hysterectomy planned within the next 6 years
* No previous endometrial ablation
Exclusion Criteria:
* Excluded from entr... | 11,370 |
Study Objectives
This phase II trial is studying how well sunitinib works in treating patients with recurrent or persistent leiomyosarcoma of the uterus. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Conditions: Recurrent Ut... | Inclusion Criteria:
* Histologically confirmed leiomyosarcoma of the uterus
* Recurrent or persistent disease
* Refractory to curative therapy or established treatments
* Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan
* A... | 21,114 |
Study Objectives
The purpose of this study is to evaluate the efficacy of treatment with azacitidine (an FDA approved drug for the treatment of MDS) and high dose ascorbic acid in patients with TET2 mutations. This approach is intended to enhance the enzymatic activity of TET2 protein, which in term may help to improve... | Inclusion Criteria:
* Patients must have a confirmed heterozygous TET2 mutations identified by next generation targeted deep sequencing.
* Patients must have MDS, or MDS/MPN overlap defined by 2016 World Health Organization (WHO) criteria. Both newly diagnosed or previously treated MDS or MDS/MPN patients are eligible... | 8,715 |
Study Objectives
3-Hydroxy-3-methylglutaryl CoA reductase inhibitors, commonly referred to as the statins, have proven therapeutic and preventative effects in cardiovascular diseases. Recently, there are emerging interests in their use as anticancer agents based on preclinical evidence of their antiproliferative, proap... | Inclusion Criteria:
* Histologic or cytologic diagnosis of SCLC
* Extensive-stage disease, defined as disease extending beyond one hemithorax or involving contralateral mediastinal, hilar or supraclavicular lymph nodes, and/or pleural effusion.
* No prior chemotherapy, immunotherapy, or radiotherapy
* Performance stat... | 14,368 |
Study Objectives
This open-label single arm study will evaluate the efficacy and safety of Avastin added to XELOX or FOLFOX in patients with metastatic colorectal cancer and disease progression on 1st line therapy with FOLFIRI plus Avastin. Patients will receive either Avastin (7.5mg/kg iv infusion every 3 weeks) and s... | Inclusion Criteria:
* adult patients >=18 years
* metastatic colorectal cancer
* at least 1 measurable lesion according to RECIST v. 1.1
* patients with disease progression with prior FOLFIRI + Avastin therapy who are not candidates for primary metastasectomy
* disease progression <= 8 weeks after last dose of Avastin... | 10,978 |
Study Objectives
The purpose of this study is to determine the effectiveness and safety of PROCRIT (Epoetin alfa) at a starting dose of 60,000 Units (U) once every week (QW) to a target hemoglobin (Hb) of 12 g/dL (Initiation Phase), followed by a dose of 80,000 Units once every three weeks (Q3W) to maintain a Hb range ... | Inclusion Criteria:
* Histologically confirmed diagnosis of non-myeloid malignancy and receiving chemotherapy
* Baseline Hb of <= 11 g/dL
* Planned chemotherapy for a minimum of 15 weeks to be administered every 3 weeks
* Female patients with reproductive potential must have a negative serum pregnancy test at screenin... | 16,094 |
Study Objectives
This study will evaluate the efficacy and safety of treatment with oral capecitabine or intravenous (IV) 5-fluorouracil (5-FU), in combination with epirubicin and cyclophosphamide, prior to surgery in participants with breast cancer. The participants will receive 4 cycles of neoadjuvant Capecitabine + ... | Inclusion Criteria:
* Females with a unilateral, non-inflammatory, non-multicentric, non-metastatic breast adenocarcinoma, not considered candidates for conservative management, and whose diagnosis had been histologically confirmed as T2 <= age <= 3, N0 <= age <= 1, M0 according to the tumor-nodes-metastasis (TNM) cla... | 21,023 |
Study Objectives
Immune checkpoint inhibitors(ICIs) combined with angiogenesis inhibitors may is synergistic in elderly patients with advanced non-small cell lung cancer(NSCLC), however its true efficacy is still unclear. The investigators retrospectively compared clinical efficacy and safety of driver-negative elderly... | Inclusion Criteria:
* Age >=65 years.
* Stage IV according to the AJCC Cancer grading manual (8th edition).
* Histologically confirmed NSCLC.
* No driver mutations.
* Received at least 2 courses of immunotherapy.
* Expected survival time > 3 months.
* No concurrent malignancy.
* Not participating in a clinical trial.
... | 2,455 |
Study Objectives
The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent pharyngeal cancer.
Conditions: Recurrent Pharyngeal Cancer
Intervention / Treatment:
DEVICE: Cryosurgery, BIOLOGICAL: NK immunotherapy
Location: China
Study Design and Phases
Study Type: INTERVENTIONA... | Inclusion Criteria:
* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1 <= age <= 6, the maximum tumor length < 5 cm
* KPS >= 70, lifespan > 6 months
* Platelet count >= 80×109/L，white blood cell count >= 3×109/L, neutrophil... | 7,883 |
Study Objectives
This multi-center, open-label, pharmacokinetic study will evaluate the bioequivalence (BE) or relative bioavailability (rBA) of three new idasanutlin-tablet variants compared to the reference tablet formulation following oral administration of a 300 milligrams (mg) dose in participants with solid tumor... | Inclusion Criteria:
* Participant must have histologically or cytologically confirmed advanced malignancies, except all forms of leukemia and lymphoma, for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the participant
* Measureable or evaluable disease b... | 5,532 |
Study Objectives
Background:
Patients with the genetic disorder neurofibromatosis Type 1 (NF1) are at increased risk of developing tumors of the central and peripheral nervous system. These include plexiform neurofibromas. The conventional treatment of these internal plexiform neurofibromas is surgery. This surgery ca... | Inclusion Criteria:
* Clinical diagnosis of NF1, according to NIH criteria, with internal plexiform neurofibroma (PN) and at least 1 of criteria for NF1:
6 or more café-au-lait spots Freckling in the axilla or groin Optic glioma 2 or more Lisch nodules Distinctive bony lesion
1-degree relative with NF1
* At leas... | 137 |
Study Objectives
The purpose of this study is to assess pharmacodynamics and safety of JNJ-212082 in order to select the recommended dose of JNJ-212082 for patients with castration resistant prostate cancer.
Conditions: Prostatic Neoplasms
Intervention / Treatment:
DRUG: JNJ-212082
Location: Japan
Study Design and ... | Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate, but not with neuroendocrine differentiation or of small cell histology
* No Prior cytotoxic chemotherapy (including estramustine) for the treatment of prostate cancer
* Surgically or medically castrated, with testosterone l... | 5,357 |
Study Objectives
THe primary objective is to estimate the response rate at 6 months to Gleevec® in patients with plexiform neurofibromas
Conditions: Neurofibromatosis
Intervention / Treatment:
DRUG: Gleevec
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TRE... | Inclusion Criteria:
* Patients 3 <= age <= 65 years.
* Diagnosis of neurofibromatosis (NF1), as outpatients.
* Presence of clinically significant plexiform neurofibromas (biopsy proven if possible with tissue blocks available); that is tumors that are potentially life threatening or are impinging on vital structures o... | 16,528 |
Study Objectives
The purpose of this study is to determine whether using FOLFIRINOX chemotherapy and Stereotactic Body Radiation Therapy (SBRT) prior to surgery in patients with pancreatic cancer is safe and well tolerated. This study will obtain preliminary data on the response of the cancer to this therapy by Magneti... | Inclusion Criteria: Patients eligible must have:
* Histologic or cytologic diagnosis of pancreatic adenocarcinoma.
* Radiographically resectable or borderline resectable disease as reviewed by an experienced surgical oncologist at Emory.
* Age >= 21 years.
* Not received prior chemotherapy or radiation for pancreatic ... | 9,899 |
Study Objectives
To monitor the safety profile and efficacy of GIOTRIF® (afatinib dimaleate, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
Conditions: Carcinoma, Non-Small-Cell Lung
Intervention / Treatment:
DRUG: GIOTRIF 20mg, DRUG: GIOTRIF 40mg, DRUG: GIOTRIF 30mg
L... | Inclusion criteria:
* Patients who have been started on GIOTRIF® in accordance with the approved label in Korea
* Age = 19 years at enrolment
* Patients who have signed on the data release consent form
Exclusion criteria:
* Known hypersensitivity to afatinib or any of its excipients
* Patients with rare hereditary c... | 21,052 |
Study Objectives
The purpose of the study is to determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR).
Conditions: Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: CEP-7... | Inclusion criteria:
* cytological confirmation of AML;
* relapsed disease following first CR of 1 month(30days)to 24 months(730days). The time from first relapse to study entry (start of first course of induction chemotherapy) must be no longer than 30days;
* confirmation of FLT-3 activating mutation positive status a... | 10,194 |
Study Objectives
The objective of this study is to evaluate the efficacy and safety of imiquimod cream versus placebo cream when used after cryosurgery in the treatment of actinic keratoses (AKs).
Conditions: Actinic Keratosis
Intervention / Treatment:
DRUG: imiquimod cream, DRUG: placebo cream
Location: United Stat... | Inclusion Criteria:
* In good general health
* Negative urine pregnancy test (for women of child-bearing potential) and agree to use an approved method of birth control while enrolled in the study.
* Prior to cryosurgery, have >= 10 clinically typical (visible or palpable) AKs in an area that exceeds 25 cm2 on the fac... | 17,454 |
Study Objectives
Vaccines made from peptides that are found on leukemia cells may make the body build an immune response and kill cancer cells. Combining vaccine therapy with the immune adjuvant Montanide ISA-51 may be a more effective treatment for chronic myeloid leukemia, acute myeloid leukemia, or myelodysplastic s... | Inclusion Criteria:
* Patients must be HLA-A2 positive at one allele
* Patients with CML in chronic phase or early accelerated phase, who are not eligible for BMT or interferon, or have failed standard therapy, or have relapsed after BMT
* Patients with MDS (FAB subtypes RAEB, and RAEBt) or AML in second or subsequent... | 16,305 |
Study Objectives
This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m... | Inclusion Criteria:
* adult patients >=18 years;
* metastatic colorectal cancer;
* >=1 target lesion;
* failed first-line chemotherapy with 5-fluorouracil and irinotecan.
Exclusion Criteria:
* previous treatment with oxaliplatin;
* progressive or recurrent disease during or within 6 months of completion of first-lin... | 4,337 |
Study Objectives
Stage IIIA non-small cell lung cancers comprising a mediastinal ganglionic invasion N2 account for 20 to 30% of the NSCLCs. They are almost always potentially resectable, but the results obtained by surgery alone or surgery followed by chemotherapy (CT) and/or radiotherapy (RT) are insufficient. The ne... | Inclusion Criteria:
* Operable and resectable stage IIIA (T1 <= age <= 3, N2) NSCLC
* World Health Organization (WHO) performance status of 1 or less
Exclusion Criteria:
* Severe cardiac, respiratory, renal or hepatic failure | 1,029 |
Study Objectives
This is a single-arm, open-label, single-center prospective phase II study to evaluate the efficacy and safety of rechallenge chemotherapy in the third or later-line treatment in patients with advanced colorectal cancer. The primary end point is progression free survival (PFS). A total of 42 patients w... | Inclusion Criteria
* Patients age between 18 and 80 years
* Histologically confirmed metastatic colorectal cancer (mCRC)
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Treatment failure to at least two lines of chemotherapy (regimens should include oxaliplatin, fluorouracil and irinoteca... | 8,478 |
Study Objectives
The investigators will look for the presence of the fusion gene in all patients operated on for glioma. This search will be limited to all gliomas that show no IDH1 mutation, the latter being sought in both routine and anomalies never co-existing.
The hypothesis is that the rate of progression-free su... | Inclusion criteria:
* Recurrent glioma after standard treatment, expressing the FGFR3-TACC3 or FGFR1-TACC1 fusion gene as confirmed by RT-PCR sequencing.
* First recurrence occurring more than three months from the end of the radiotherapy or occurring outside the irradiated volume.
* World Health Organisation performa... | 12,290 |
Study Objectives
Evaluation of the potential perpetrator effect of BAY1841788 (ODM-201) on rosuvastatin pharmacokinetics.
PK of BAY1841788 (ODM-201) after single and repeated administration in male and female subjects.
Conditions: Healthy Volunteers, Pharmacokinetics, Drug Interaction
Intervention / Treatment:
DRUG:... | Inclusion Criteria:
* Healthy subject - as determined by medical history, physical examination and all procedures required by this protocol.
* Age: 45 <= age <= 65 at the screening visit.
* Race: White.
* Body mass index (BMI): >=18.0 and <=29.9 kg/m*2.
* Adequate venous access (frequent blood sampling).
* Ability to ... | 20,296 |
Study Objectives
Patients with metastatic breast cancer considered HER2 negative are screened for HER2-amplified circulating tumor cells. If at least HER2-amplified circulating tumor cell is detected, patients are treated by Trastuzumab - Emtansine (T-DM1) in a single arm phase II with an adaptive design.
Conditions: ... | Inclusion Criteria:
Inclusion criteria for screening:
* Breast adenocarcinoma considered HER2-negative on the primary tumour or unknown status HER2
* A least one metastatic site and/or inoperable loco-regional relapse
* Measurable disease (RECIST v1.1)
* Age from 18 <= age <= 75
* Performance status of 0 <= age <= 2
... | 15,575 |
Study Objectives
The purpose of this study is to evaluate the tolerability of oral azacitidine in the treatment of patients with Myelodysplastic Syndromes (MDS).
Conditions: Myelodysplastic Syndromes
Intervention / Treatment:
DRUG: Oral azacitidine
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
... | Inclusion Criteria:
Patients must satisfy the following criteria to be enrolled in the study:
* Have a documented diagnosis of myelodysplastic syndromes (MDS) according to World Health Organization (WHO) 2008 classification
* Age >= 20 years;
* Written informed consent;
* Eastern Cooperative Oncology Group (ECOG) per... | 11,325 |
Study Objectives
The purpose of this study is to find the safest and most effective dose of the drugs bevacizumab and everolimus given in combination for the treatment of metastatic colorectal cancer. Bevacizumab (also called Avastin™) is a drug that is given intravenously (through a vein). Everolimus (also called RAD0... | Inclusion Criteria:
* Patients must have histologically confirmed adenocarcinoma of the colon or rectum that has progressed on, or patient could not tolerate, fluoropyrimidine, oxaliplatin, irinotecan, and cetuximab and/or panitumumab chemotherapy. Disease must be measurable or evaluable by Response Evaluation Criteri... | 15,418 |
Study Objectives
The main purpose of REVLIMID® DUE (Drug Use Examination) is to collect and evaluate the safety information of Korean Multiple Myeloma patients treated with REVLIMID® according to the approved package insert, after approval of marketing authorization for new drug in Korea. In addition, the efficacy info... | Inclusion Criteria:
* Korean male or female who are diagnosed with Multiple Myeloma
* In-patients or out patients during the REVLIMID® Drug Use Examination period who are intended to be treated with REVLIMID ®
* Patients who are registered for Risk Management Program of Celgene
Exclusion Criteria:
* There's no exclu... | 18,316 |
Study Objectives
The goal of this clinical research study is to learn if minocycline can reduce the symptoms reported by patients with oropharynx cancer, nasopharynx cancer, or unknown primary cancer of head and neck, who receive treatment with radiation therapy.
Conditions: Oropharynx Cancer
Intervention / Treatment... | Inclusion Criteria:
* Patients with a pathologically proven diagnosis of oropharyngeal cancer, nasopharyngeal cancer, or unknown primary cancer of head and neck in MDACC receiving radiation therapy with or without induction chemotherapy.
* Patients > = 18 years.
* Patients with the above cancers, T0, TX, T1 to T3, N a... | 1,397 |
Study Objectives
The goal of this clinical research study is to find the best dose of clofarabine and fludarabine that can be given with busulfan followed by an allogeneic blood stem cell transplant. Researchers will study whether this combination can help to control the disease, and look at the safety of this combinat... | Inclusion Criteria:
* Diagnosis or 1) Acute myeloid leukemia past first remission, in first or subsequent relapse, or induction failures, 2) Myelodysplastic syndromes with intermediate or high risk International Prognostic Scoring System score (IPSS scores) (16), and having failed previous chemotherapy, or 3) Chronic ... | 6,613 |
Study Objectives
To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint will be overall survival.
Conditions: High Risk Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: CPX-351, DRU... | Inclusion Criteria:
* Ability to understand and voluntarily give informed consent
* Age 60 <= age <= 75 years at the time of diagnosis of AML
* Pathological diagnosis of AML according to WHO criteria (with at least 20% blasts in the peripheral blood or bone marrow)
* Confirmation of:
* Therapy related AML: t-AML mu... | 3,910 |
Study Objectives
Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese hamster ovary (CHO) cells. A randomized, double-blind, single-dose, parallel phase I study comparing trastuzumab for injection... | Inclusion Criteria:
* Fully understand the purpose of the trial, and have a basic understanding of the pharmacological effects and possible adverse reactions of the drug under study; Voluntary written informed consent in accordance with the Helsinki Declaration;
* Healthy male subjects aged >= 18 years and <= 65 years... | 9,364 |
Study Objectives
This is a clinical research study of a new investigational treatment for cancer called "DTI-015" to be given by intratumoral injection. Intratumoral injection is when drug is injected directly into the tumor. This study will help doctors find out what is the best dose level for DTI-015 and if this trea... | Inclusion Criteria:
* Histologic proof of recurrent previously irradiated supratentorial malignant gliomas including anaplastic astrocytoma, glioblastoma multiforme, anaplastic oligodendroglioma, or anaplastic ependymoma.
* It must be judged that gross total resection of the patient's tumor is not possible or the pati... | 12,536 |
Study Objectives
The main objective of the trial is to document the safety of the combination (escalation doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of cisplatin, 80 mg/sqm). Safety will be established by clinical and laboratory assessment according to National Cancer Institute Common Toxici... | Inclusion Criteria:
* Patients >=18 years with advanced or metastatic solid tumor not amenable to any clinical improvement by current standard treatments and suitable for a treatment with cisplatin
* Life expectancy more than 3 months
* ECOG Performance status 0 <= age <= 1
* Absence of any conditions in which ... | 21,577 |
Study Objectives
The main objective of this study is to assess safety, tolerability, and pharmacokinetics (PK) of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and ABBV-181 in participants with recurrent/metastatic (R/M) head and neck squamous... | Inclusion Criteria:
* Participants should weigh at least 35 kg.
* Eastern Cooperative Oncology Group performance status of 0 or 1 and a life expectancy of >= 3 months.
* Participant have >= 1 lesion accessible for intratumoral injection.
* Histologically or cytologically confirmed R/M HNSCC (of the following 4 subsite... | 20,262 |
Study Objectives
To assess if targeting activating EGFR and HER2 mutations in Non-Small Cell Lung Cancer (NSCLC) is more effective when these mutations are truncal dominant mutations (≥50%), as opposed to non-dominant (≥5 to \<50%) or low frequency mutations (\<5%).
This trial will be available to patients registered ... | Inclusion Criteria:
* Subjects must be willing to have a biopsy of relapsed disease. Consent will be obtained through the TRACERx study or with the 'trial entry tissue collection' consent form(non-TRACERx patients). Procurement of the biopsy sample is not necessary at the time of trial registration. However, patients ... | 17,273 |
Study Objectives
The purpose of this study is to find out what effects an experimental drug, called interleukin 21 or rIL-21, will have on malignant melanoma and whether these effects look promising compared to dacarbazine. In addition, this study will look at the side effects of rIL-21, and some special blood tests wi... | Inclusion Criteria:
* Histologically documented cutaneous malignant melanoma which is recurrent or metastatic and is not curable by surgical or other means.
* Patients must have tumour tissue from their primary and/or metastatic tumour available to assess putative molecular markers of response (paraffin block or 12 un... | 12,235 |
Study Objectives
The purpose of this study is to: 1) identify the palliative care needs of Emergency Department patients with advanced cancer, and determine if these needs can be rapidly assessed in the ED; 2) determine whether early palliative care consultation improves survival, quality of life and other burdensome s... | Inclusion Criteria:
* >= 18 years age
* Speak English or Spanish
* ED patient with an advanced solid malignancy
Exclusion Criteria:
* Have already been seen by palliative care team
* Cognitive deficits
* Children or adolescents
* No confirmed history of active cancer
* Do not speak English or Spanish
* Reside outsid... | 5,665 |
Study Objectives
The purpose of this study is to determine the safety of multiple intravenous infusions of MORAb-004.
Conditions: Solid Tumor
Intervention / Treatment:
DRUG: MORAb-004 (monoclonal antibody to TEM1)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpo... | Inclusion Criteria:
* Subjects >=18 years.
* Subjects with any malignant solid tumor without intracranial involvement or metastases diagnosed by standard pathology criteria that has failed standard chemotherapy.
* Subject must have disease, as defined by RECIST or evaluable by clinical signs/symptoms (e.g., ascites, p... | 22,360 |
Study Objectives
The purpose of this interventional study is to determine the feasibility to combine standard chemotherapy (Carbo/Caelyx or doxorubicin) for recurrent ovarian cancer with immunotherapy (Tocilizumab and Peg-Intron).
This study combines standard chemotherapy Carboplatin-Caelyx or doxorubicin with a monoc... | Inclusion Criteria:
* Histologically proven epithelial ovarian cancer
* Progression of disease or relapse after previous therapy with platinum
* Measurable disease (RECIST 1.1) or elevated CA125 > 2 times the upper normal limit (UNL) within 3 months and confirmed
* Age >=18 years
* WHO performance status 0 <= age <= 2... | 17,142 |
Study Objectives
This is a non-randomised study assessing the technique of using indocyanine green as a fluorescent dye to highlight the thoracic duct during oesophectomy.
Conditions: Chylothorax, Esophageal Cancer, Thoracic Duct Intra-Operative Injury
Intervention / Treatment:
DRUG: Indocyanine Green
Location: Unit... | Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Undergoing elective oesophagectomy
Exclusion Criteria:
* Known allergy to iodine or ICG
* Female patient who is pregnant, planning pregnancy or breastfeeding
* Pa... | 12,890 |
Study Objectives
To estimate the real-world rates of recurrent Venous thromboembolism (VTE), major bleeding and all-cause mortality in patients with Cancer-associated thrombosis (CAT) treated with rivaroxaban
Conditions: Venous Thromboembolism
Intervention / Treatment:
DRUG: Rivaroxaban (Xarelto, BAY59-7939)
Locatio... | Inclusion Criteria:
* Adult patients (>=18 years-of-age) with active cancer
* Patient with at least one index venous thromboembolism (VTE )
* >=6-months of continuous eligibility prior to the index VTE event (baseline period).
* Newly initiated on rivaroxaban
Exclusion Criteria:
* Patients with any medical claim for... | 2,495 |
Study Objectives
Despite significant progress in overall survival and event-free survival in Pediatric Hematopoietic Stem Cell Transplant (HSCT), therapeutic options for graft-versus-host disease control remain limited, particularly in steroid-refractory patients. Several strategies have been proposed in the last 20 ye... | Inclusion Criteria:
* Age of the patients between 0 and 18;
* Allogeneic HSCT recipient;
* Onset of clinical signs of acute skin, gastrointestinal or hepatic GVHD according to the Glucksberg classification;
* At least five days of steroid treatment (minimum 1 mg/kg of methylprednisone or equivalent) for systemic aGVHD... | 12,423 |
Study Objectives
The purpose of this study is to define the Maximum tolerated dose of SU14813 when administered as single agent in patients with solid tumors.
Conditions: Neoplasms, Solid Tumors
Intervention / Treatment:
DRUG: SU014813
Location: Germany, Netherlands
Study Design and Phases
Study Type: INTERVENTIONA... | Inclusion Criteria:
* Patients with a histologically proven advanced solid malignancy for which no recognized therapy was available or for which standard therapy had failed
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Serum albumin >=3.0 g/dL and adequate haemopoietic, renal and liver fun... | 746 |
Study Objectives
The primary objective of this study is aimed at analyzing the ICU triage practices of clinicians at a cancer hospital with and without the use of an algorithm-based triage tool, and to assess whether or not the triage tool improves the consensus amongst practioners on the prioritization of patients for... | Inclusion Criteria:
1) Study participant must be a health care provider who frequently refers or accepts oncologic patients to the ICU
Exclusion Criteria:
1) none | 20,929 |
Study Objectives
Despite these initial positive signals in recent statistics, breast cancer continues to claim a substantial number of lives approximately 500,000 deaths worldwide in 2005 Thus the current treatment paradigm - surgery, radiation and systemic chemo and or hormonal therapy and biological therapies -still ... | Inclusion Criteria:
* Signed informed consent must be obtained according to local ethical committee requirements.
* Subjects must be older than 18 years.
* Histologically confirmed invasive adenocarcinoma of the breast which is stage IIIb, stage IIIc with T4 lesion, or stage IV disease [according to AJCC 6th edition]
... | 11,579 |
Study Objectives
This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.
Conditions: Gastrointestinal Stromal Tumors
Intervention / Treatment:
DRUG: AMN107
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
... | Inclusion Criteria:
* Documented disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib
* At least one measurable site of disease on CT/MRI scan
* PS<=2
* Normal organ, electrolyte, and bone marrow function
Exclusion Criteria:
* Previous treatment with nilotinib or any ... | 2,701 |
Study Objectives
This study is single-arm, none randomized, open label, two-dose-cohorts, single center clinical trial for evaluation of the safety and efficacy of Oshadi D and Oshadi R in patients with BCC. Patients will receive Oshadi D and Oshadi R for 60 -90 days until the planned surgical excision of the lesion.
... | Inclusion Criteria:
* Age > 21 years with tissue confirmed diagnosis of local BCC.
* Patient is candidate for surgical excision of the BCC in few months.
* BCC lesion >=10mm in its longest diameter.
* Sexually active fertile patients and their partners must agree to use medically accepted methods of contraception duri... | 14,263 |
Study Objectives
The purpose of this research study is to determine the safest and most effective dose of 5-FU that can be given with docetaxel (Taxotere), Cisplatin and cetuximab to patients with newly diagnosed locally advanced squamous cell carcinoma of the head and neck. We will also be studying the toxicity of thi... | Inclusion Criteria:
* Histologically or cytologically proven squamous cell carcinoma of the head and neck.
* Primary tumor sites eligible: oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx. Unknown primary SCC will also be eligible.
* Stage 3 or 4 disease without evidence of distant metastases verified by c... | 18,483 |
Study Objectives
In the First-in-Human, JWAA trial, the LY2780301 displayed a favourable safety profile, a high pharmacokinetic exposure and the ability to decrease pS6. LY2780301 has shown synergistic activity in combination with targeted agents or chemotherapy including gemcitabine. We propose herein to combine LY278... | Inclusion Criteria:
* Dose Escalation portion (Part 1): have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic disease (including Non-Hodgkin's Lymphoma) with selected molecular alterations and for which no proven effective therapy exists. ;
* Dose Confirmation portion (P... | 3,669 |
Study Objectives
This phase II trial is studying the side effects of pazopanib hydrochloride and to see how well it works in treating patients with metastatic melanoma that cannot be removed by surgery. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and... | Inclusion Criteria:
* Histologically confirmed unresectable malignant melanoma
* Radiographic or clinical evidence of metastatic disease
* Measurable disease with >= 1 lesion whose longest diameter can be measured as >= 2.0 cm by CT or MRI scans or >= 1.0 cm by spiral CT scan
* Disease that is measurable by phys... | 11,682 |
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