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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...
Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination with Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients with Untreated NPM1 Mutated or KMT2A Rearranged

Principal Investigator:

Joseph G. Jurcic, MD

Contact Number:

212-342-5162

NCT Number:

NCT07007312

Phase:

III

The purpose of this study is to evaluate an investigational drug called ziftomenib when added to either non-intensive chemotherapy (venetoclax and azacitidine) or intensive chemotherapy (cytarabine and daunorubicin), followed by ziftomenib maintenance therapy. Investigational means that ziftomenib has not been approved by the Food and Drug Administration (FDA) for use outside of research studies. Maintenance therapy refers to ongoing treatment given after the initial therapy to help keep the cancer from returning. Ziftomenib is being studied as a possible treatment for acute myeloid leukemia...
Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab inCombination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary TractCancer (ARTEMIDE-Biliary02)

Principal Investigator:

Aiwu R He, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT07221253

Population:

Adult

Phase:

III

The purpose of this study is to understand the effectiveness and safety of rilvegostomig in combination with chemotherapy to that of standard treatment for advanced biliary tract cancer (durvalumab in combination with gemcitabine and cisplatin). We are also performing this study to better understand advanced biliary tract cancer and associated health problems. Rilvegostomig has not been approved by the Food and Drug Administration (FDA). Durvalumab, gemcitabine, and cisplatin are FDA approved to treat biliary tract cancer, but the combination of rilvegostomig, gemcitabine, and cisplatin is...
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,...
Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)

Principal Investigator:

Eileen Patricia Connolly, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT06745024

Phase:

III

This study is being done to answer the following question: Will preventative radiation therapy lower the number of bone metastases-related complications (such as fracture caused by the tumor in the bone and tumor pushing on the spinal cord) compared to the usual approach? We are doing this study because we want to find out if this approach is better or worse than the usual approach for patients with high risk bone metastases. The usual approach for patients who are not in a study is drugs that prevent bone loss, in addition to continuing to receive drug treatment for their primary cancer, or...
RASolute 304: A Phase 3 Multicenter, Open-label, Randomized,2-Arm Study of Adjuvant Daraxonrasib versus Standard of CareObservation Following Completion of Neoadjuvant and/orAdjuvant Chemotherapy in Patients with Resected PancreaticDuctal Adenocarcinoma

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT07252232

Population:

Adult

Phase:

III

The purpose of this study is to test an experimental drug called Daraxonrasib (RMC-6236) compared to standard of care observation after finishinged chemotherapy given either before surgery to shrink the tumor (neoadjuvant chemotherapy) or after surgery to kill remaining cancer cells in patients with resected PDAC. Daraxonsrasib (RMC-6236) is not approved by the United States Food and Drug Administration (FDA). People who usually have this type of cancer typically receive surgery followed by chemotherapy, and then are monitored without additional treatment. This study is different because it...
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...
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...
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...
A Multipart, Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ELA026 in Participants with Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

Principal Investigator:

Seda S Tolu, MD

Contact Number:

212-342-5162

NCT Number:

NCT05416307

Population:

Adult

Phase:

II/III

This study is testing an investigational drug called ELA026 in people who have a rare and serious immune condition called secondary hemophagocytic lymphohistiocytosis (sHLH). Investigational means that it is not approved by the United States Food and Drug Administration (FDA). sHLH causes the immune system to become overactive, leading to inflammation and damage to organs. ELA026 is designed to target specific immune cells that may contribute to the inflammation seen in sHLH. The study will also use dexamethasone, an FDA-approved steroid commonly used to help control inflammation. In this...

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