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Targeted (Intra)arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab-Paclitaxel following Induction with Sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Unresectable Locally Advanced Pancreatic Cancer (TIGeR-PaC)

Principal Investigator:

Susan E. Bates, MD

Contact Number:

212-342-5162

NCT Number:

NCT03257033

Population:

Adult

Phase:

III

The purpose of this research study is to find out whether using a newer method of targeted local delivery of the chemotherapy directly into an artery close to the pancreas tumor after treatment with standard chemotherapy that is delivered by vein is more effective at preventing the tumor from growing as compared with just receiving standard chemotherapy into a vein that goes throughout the body. This study will compare how IA and IV medication affects the time that patients survive and their quality of life. Are you Eligible? (Inclusion Criteria) Age ≥ 18 years Histologically or...
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...
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

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 Phase II/III Randomized Study of R-MiniCHOP with or Without CC-486 (Oral Azacitidine) in Participants Age 75 Years or Older with Newly Diagnosed Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma, Transformed Lymphoma, and High-Grade B-Cell

Principal Investigator:

Jennifer Effie Amengual, MD

Contact Number:

212-342-5162

NCT Number:

NCT04799275

Population:

Adult

Phase:

II/III

This study is being done to answer the following questions: Will patients that are 75 years of age or older who were recently diagnosed with Diffuse Large B Cell Lymphoma (DLBCL) be able to take the study drug CC-486 (oral azacitidine) plus the standard drug therapy that fights cancer cells for at least 4 cycles of therapy (a cycle = 21 days; 4 cycles is 12 weeks): • without significantly more side effects than patients taking the standard drug therapy alone? • have longer, shorter, or the same amount of time without the disease getting worse (progression) than patients taking the...
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 Randomized, Double-Blind, Placebo-Controlled Study of Nab-Paclitaxel and Gemcitabine With Or Without SBP-101 in Subjects Previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT05254171

Population:

Adult

Phase:

II/III

The purpose of this study is to investigate how well SBP-101, the study drug, or a placebo works in combination with nap-paclixatel and gemcitabine to treat adenocarcinoma in study participants who have never received treatment for their cancer.A placebo is an inert substance that does not contain any study drug and has no therapeutic value. Placebos are used in studies to help the study team determine if any progress occurs due to the study treatment or due to another outside factor that is not being studied in this research. Participants will be randomized (randomly assigned by a computer)...
AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT), A Phase 2/3 Study, An Intergroup Study by Société Internationale d’Oncologie Pédiatrique (SIOPEL) in collaboration with COG and the Japanese

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT03533582

Population:

Pediatrics/Adult

Phase:

II/III

s phase 2/3 study is examining the best treatments for pediatric liver tumors. It is looking to improve survival for patients with a poor prognosis while potentially reducing therapy and the risk for side effects in patients with good prognoses. Hepatoblastoma and hepatocellular carcinoma are the liver tumors being studied. Are you Eligible? (Inclusion Criteria) Patients must be 30 years of age or younger Patients must have not previously received treatment for either hepatoblastoma or hepatocellular carcinoma Patients must also meet all eligibility criteria as outlined in the study protocol...
A Two-staged, Phase 2/3, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of REC-2282 in Participants with Progressive NF2 Mutated Meningiomas

Principal Investigator:

Gurcharanjeet Kaur, MD

Contact Number:

212-342-5162

NCT Number:

NCT05130866

Population:

Adult

Phase:

II/III

The purpose of this study is to find out if REC-2282, an investigational new drug, is an effective and safe treatment in patients with progressive NF2 mutated meningiomas who have either NF2 disease-related meningioma or recurrent sporadic meningiomas that have NF2 mutation. “Investigational new drug” means a drug that has not been approved as a marketed product (i.e., available to be prescribed or sold) by any regulatory authorities, such as the US Food and Drug Administration (FDA). REC-2282 is a potential treatment for a variety of tumors where various enzymes and proteins play...
A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination with Paclitaxel versus Paclitaxel Alone in Adult Patients with Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers who have received One Prior Systemic Chemotherapy

Principal Investigator:

Linda Y. Wu, MD

Contact Number:

212-342-5162

NCT Number:

NCT05506943

Population:

Adult

Phase:

II/III

This study is being done and paid for by Compass Therapeutics (Compass), a company that does drug research studies in order to develop new drugs. Compass is studying a drug called CTX-009. This is an experimental drug being developed to potentially stimulate the immune system to fight against cancer (called, the “study drug”). “Experimental” means that the study drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA) or by any other regulatory authority in any other country. This study will also use...
A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants with Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT06225596

Population:

Adult

Phase:

II/III

The purpose of this study aims to determine if BT8009, when given in combination with pembrolizumab, works against urothelial cancer. This will be compared to standard chemotherapy treatment followed by avelumab therapy. This research study also aims to understand the side effects of BT8009 when given in combination with pembrolizumab. The study drug BT8009 is investigational (i.e., experimental). An investigational drug is one that has not been approved by the Food and Drug Administration (FDA) to treat a certain condition or illness or a certain type of patient. Pembrolizumab is an antibody...

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