An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination With Cisplatin and Capecitabine Versus Cisplatin and Capecitabine Alone in Patients With Advanced or Metastatic Solid Tumors and Previously Untreated Gastric Cancer
This open-label, multicenter, randomized study will consist of 2 phases:
Phase Ib: a safety run-in period with 3 ascending doses of E7050 in combination with fixed
doses of Cisplatin and Capecitabine. This phase will enroll approximately 10 to 15 patients.
•Phase II: a randomized 2-arm design which will enroll 80 patients.
In the phase II portion, Patients will receive study treatment , E7050 in combination with
Cisplatin and Capecitabine versus Cisplatin and Capecitabine Alone) for approximately six
21-day cycles (18 weeks). Beyond 18 weeks, patients who are experiencing clinical benefit
may continue E7050, with or without Capecitabine (Arm 1), or may continue Capecitabine alone
(Arm 2), depending on the original randomization treatment arm. Patients will continue
treatment for as long as clinical benefit is sustained and the treatment is well tolerated,
until the occurrence of progressive disease (PD), unacceptable toxicity, withdrawal of
consent, or withdrawal by investigator, whichever occurs first. Patients will participate in
either phase Ib or phase II.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety parameter:adverse events
Phase Ib: to determine the MTD/recommended Phase II dose and characterize the pharmacokinetics (PK) of E7050 when administered in combination with Cisplatin and Capecitabine versus Cisplatin and Capecitabine Alone in Patients with Advanced or Metastatic Solid Tumors •Phase II: to evaluate the safety and tolerability of E7050 administered in combination with Cisplatin and Capecitabine versus Cisplatin and Capecitabine Alone in Patients with Previously Untreated Gastric Cancer.
until study termination; 3 years
United States: Food and Drug Administration
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Duke University Medical Center||Durham, North Carolina 27710|
|University of North Carolina at Chapel Hill||Chapel Hill, North Carolina 27599|
|Henry Ford Medical Center||Dearborn, Michigan 48126|
|Arizona Oncology Associates, PC - CASA||Tucson, Arizona 85715|
|Boca Raton Clinical Research Associates, Inc||Plantation, Florida 33324|
|Robert H. Lurie Comprenhensive Cancer Center of Northwestern University||Chicago, Illinois 60611|
|Mercy Cancer Centerr at St. Anne||Toledo, Ohio 43623|