An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Patients With Hepatocellular Carcinoma
This open-label, multicenter, randomized study will consist of a Phase Ib: a safety run-in
period with 3 ascending doses of E7050 in combination with sorafenib; and a Phase II
portion: a randomized 2-arm period. Approximately 95 patients with hepatocellular carcinoma
will be enrolled in the study (10-15 patients in the Phase Ib portion and 80 patients in the
Phase II portion). Patients will only participate in either the Phase Ib or the Phase II
portion of the study. In both Phase Ib and phase II, Patients will receive study treatment
(E7050 plus sorafenib or sorafenib alone) until the occurrence of progressive disease
(PD)for approximately six 28-day cycles (24 weeks). After 6 cycles. ath the discretion of
the Investigator and in consultation with the Medical Monitor, patients who are experiencing
clinical benefit may continue E7050, with or without sorafenib (Arm 1), or may continue
sorafenib alone (Arm 2), depending on the original randomization treatment arm, for as long
as clinical benefit is sustained and the treatment is well tolerated. Patients will be
followed until death following completion of therapy.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety Parameters- Adverse Event (AEs)
Phase Ib: To determine the MTD/recommended Phase II dose and characterize the pharmacokinetics (PK) of E7050 when administered in combination with sorafenib in patients with locally advanced or metastatic HCC; Phase II: To evaluate the safety and tolerability of E7050 when administered in combination with sorafenib as compared with sorafenib alone in patients with locally advanced or metastatic HCC.
until study termination
Yes
Melissa J Versola, RN
Study Director
Quintiles
United States: Food and Drug Administration
E7050-701
NCT01271504
April 2011
December 2014
Name | Location |
---|---|
Tufts University School of Medicine | Boston, Massachusetts 02111 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Henry Ford Health System | Detroit, Michigan 48202 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
University of North Carolina at Chapel Hill | Chapel Hill, North Carolina 27599 |
Tennessee Oncology | Nashville, Tennessee 37203 |
Florida Cancer Specialists-Broadway | Ft. Myers, Florida 33916 |
Arizona Oncology Associates, PC-CASA | Tucson, Arizona 85715 |
Peggy & Charles Stephenson Oklahoma Cancer Ctr | Oklahoma City, Oklahoma 73104 |
Mercy Cancer Center at St. Anne | Toledo, Ohio 43623 |