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ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

Principal Investigator:

Aya Haggiagi, MD

Contact Number:

212-342-5162

NCT Number:

NCT05580562

Population:

Adult

Phase:

III

The purpose of this study is to see if ONC201 is effective in treating participants with glioma when given following radiation therapy, how safe and tolerable ONC201 as compared to using placebo (a capsule that looks like ONC201 but does not contain any active drug), and to see how well ONC201 can improve quality of life and brain functioning in patients with glioma. ONC201 is a new drug that is being developed for treating people with glioma. ONC201 may help to remove tumor cells without affecting normal cells of the body. ONC201 is a first-in-class drug, which means it is a new drug having...
Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III

Principal Investigator:

Katherine D Crew, MD

Contact Number:

212-342-5162

NCT Number:

NCT03418961

Population:

Adult

Phase:

III

To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab-based HER-2 targeted therapy. Are you Eligible? (Inclusion Criteria) Patients must have metastatic breast cancer. There is no limit for number of doses of HER-2 targeted therapy prior to registration. Patients must be at increased risk for cardiotoxicity. Patients must not have taken within 21 days prior to Step 1 Registration, be currently taking at the time of Step 1 Registration,...
Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification And Intensification Clinical Trial Evaluation (GUIDANCE)

Principal Investigator:

Israel Deutsch, MD

Contact Number:

212-342-5162

NCT Number:

NCT05050084

Population:

Adult

Phase:

III

This study is being done to answer the following questions: If a patient has unfavorable intermediate risk prostate cancer, a low gene risk score and plans to receive radiation therapy with hormone therapy, is radiation therapy alone as effective at controlling the cancer compared to the usual combination of radiation and hormone therapy? If a patient has unfavorable intermediate risk prostate cancer, a higher gene risk score and plans to receive radiation therapy with hormone therapy, does adding another new hormone therapy drug to the usual combination of radiation and hormone therapy...
RANDOMIZED TRIAL OF LIMB CRYOCOMPRESSION VERSUS CONTINUOUS COMPRESSION VERSUS LOW CYCLIC COMPRESSION FOR THE PREVENTION OF TAXANE-INDUCED PERIPHERAL NEUROPATHY

Principal Investigator:

Melissa Accordino, MD

Contact Number:

212-342-5162

NCT Number:

NCT05642611

Population:

Adult

Phase:

III

The purpose of this study is to learn which of the following 3 study approaches is the most helpful to prevent peripheral neuropathy caused by taxane chemotherapy. These approaches will use a study device, called the Paxman Limb Cryocompression System, made of wraps that cool and/or compress your arms and legs. The study will test which of the following combinations of cooling and/or compression to your arms and legs is better at preventing peripheral neuropathy: • Cryocompression (cooling plus moderate and low pressure to your arms and legs) • Continuous compression (moderate,...
RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of RMC-6236 versus Investigator’s Choice of Standard of Care Therapy in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT06625320

Population:

Adult

Phase:

III

The purpose of this study is to test an experimental drug called RMC-6236. RMC-6236 is an experimental drug, which means that it is not approved by the United States (US) Food and Drug Administration (FDA). RMC-6236 is currently being investigated in other ongoing studies, and this is the first study investigating RMC-6236 in only pancreatic cancer. You will be randomly assigned to receive either RMC-6236 or a chemotherapy regimen chosen by the study doctor (in the form of combinations of approved drugs 5-fluorouracil, leucovorin, oxaliplatin, irinotecan, and liposomal irinotecan or...
Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer (CCTG MA.39)

Principal Investigator:

Eileen Patricia Connolly, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT03488693

Population:

Adult

Phase:

III

The purpose of this study is to compare any good and bad effects of not giving regional radiotherapy to using regional radiotherapy. This study will help researchers learn if not giving regional radiotherapy is just as good as using regional radiotherapy. To be better, the approach of not giving regional radiotherapy should keep your breast cancer from coming back as good as giving regional radiotherapy. There will be about 2140 people taking part in this study. Are you Eligible? (Inclusion Criteria) To be eligible for this study, subjects must: 1. be ≥ 40 years of age. 2. have been...
The COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 Compared with T-DM1 and Tucatinib

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT04457596

Population:

Adult

Phase:

III

This study is being done to answer the following question: Is the combination of T-DM1 and a newer drug tucatinib, better than usual treatment with T-DM1 alone at preventing cancer from returning? This study is being done to find out if this approach is better or worse than the usual approach for breast cancer. The usual approach is defined as care most people get for breast cancer. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Do you have HER2-positive breast cancer and have already received treatment with chemotherapy and anti-HER2 targeted therapies followed by...
A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study of BLU-263 in Indolent Systemic Mastocytosis

Principal Investigator:

Joseph G. Jurcic, MD

Contact Number:

212-342-5162

NCT Number:

NCT04910685

Population:

Adult

Phase:

II/III

You are being asked to participate in this study because you have indolent SM (ISM) or because you have Monoclonal mast cell activation syndrome (mMCAS). Currently, there are no available targeted therapies for patients with ISM or mMCAS. The study will test the drug BLU-263. BLU-263 is a new study drug that is being developed for treating people like you, with ISM and/or mMCAS. BLU-263 is not yet approved for treating ISM and/or mMCAS by the Food and Drug Administration (FDA). BLU-263 is the first study drug in a group of drugs that prevents a specific DNA change called KIT D816V. The goal...
An International, Seamless Phase II/III Responsive Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM (GBM AGILE)

Principal Investigator:

Andrew B. Lassman, MD, FAAN, FASCO

Contact Number:

212-342-5162

NCT Number:

NCT03970447

Population:

Adult

Phase:

II/III

The purpose of this study is to evaluate multiple investigational treatments for either newly diagnosed or recurrent brain tumors to determine if any of these study treatment(s) improve overall survival as compared to standard treatments. Investigational means that these are new treatments sometimes called “study drugs” and are not approved by the Food and Drug Administration (FDA) to be used for your type of cancer. The investigational treatments in this study have been previously tested in people. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Do you...
LCH-IV International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT02205762

Population:

Pediatrics

Phase:

II/III

The LCH-IV is an international, multicenter, prospective clinical study for pediatric Langerhans Cell Histiocytosis LCH (age < 18 years). LCH is a rare disease of the immune system that may affect any age group. It can affect many different organs, including the skeleton, skin, lymph nodes, liver, lungs, spleen, hematopoiesis, or central nervous system (CNS). There are two widely recognized disease extent categories: single-system LCH (involvement of a single organ or system) and multisystem LCH (involvement of 2 or more organ systems). Patients with SS-LCH of the skeleton, skin, or the...

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