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A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating FPA144 and Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase 3 Preceded by Dose-Finding in Phase 1
Study Coordinator
Vanessa Shaw, BS, RN
484-526-6038
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Treatment Agent:Bemarituzumab
Synopsis: The purpose of the study is to test the safety, efficacy (possible usefulness), and tolerability of a new investigational compound, called FPA144, in combination with chemotherapy (a combination of 5-fluorouracil, oxaliplatin and leucovorin called mFOLFOX6) for the treatment of gastric and/or gastroesophageal cancer. FPA144 is an experimental drug being developed by Five Prime Therapeutics, Inc. (“FivePrime”), a biopharmaceutical company based in the United States of America (US). FivePrime is the study sponsor. FPA144 is not approved by the US Food and Drug Administration (FDA) or any other health authority in any country. It can only be given to patients as part of a clinical study like this one. FPA144 has been tested in a relatively small number of patients (as of March 20, 2017, a total of 64 patients have received at least 1 dose of FPA144). Therefore, information on the side effects, and efficacy of FPA144 in treating humans, is limited. Later in this form you will find a summary of the information currently available. This study consists of two phases, a Phase 1 and a Phase 3. Phase 1 of the study will be open to patients who have gastrointestinal cancer and whose doctor plans to administer at least two doses of a type of chemotherapy treatment called mFOLFOX6. Phase 3 of the study will be open to patients who have gastric or gastroesophageal cancer, have a tumor that is FGFR2b positive, and whose doctor plans to administer chemotherapy (mFOLFOX6) as therapy. The Phase 3 portion of the study will start after the Phase 1 portion is complete. Participant enrollment is limited to one of the two phases (Phase I or Phase 3). You are being asked to participate in the Phase 3 portion of the study.
The main goals of the Phase 3 portion of the study are to:
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