An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck
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 Cetuximab; and a Phase II
portion: a randomized 2-arm period. Approximately 95 patients with Platinum-Resistant
Squamous Cell Carcinoma of the head and neck 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 the phase II portion, Patients will receive study treatment (E7050 plus Cetuximab or
Cetuximab alone) for approximately six 28-day cycles (24 weeks). Beyond 24 weeks, patients
who are experiencing clinical benefit may continue E7050 plus cetuximab, cetuximab alone or
E7050 alone (Arm 1), or may continue cetuximab alone (Arm 2), depending on the original
randomization treatment arm, for as long as clinical benefit is sustained and the treatment
is well tolerated.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety Parameters- Adverse Events
Phase Ib: to determine the MTD/recommended Phase II dose and characterize the pharmacokinetics (PK) of E7050 when administered in combination with cetuximab in patients with platinum-resistant, recurrent and/or metastatic squamous cell carcinoma for the head and neck (SCCHN); Phase II: to evaluate the safety and tolerability of E7050 administered in combination with cetuximab compared with cetuximab alone in patients with platinum-resistant, recurrent and/or metastatic SCCHN.
until study termination; 3 years
Yes
Melissa J Versola, RN
Study Director
Innovation Quintiles
United States: Food and Drug Administration
E7050-702
NCT01332266
May 2011
October 2014
Name | Location |
---|---|
Tufts University School of Medicine | Boston, Massachusetts 02111 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Washington University | St. Louis, Missouri 63110 |
Tennessee Oncology | Nashville, Tennessee 37203 |
Peggy & Charles Stephenson Oklahoma Cancer Ctr | Oklahoma City, Oklahoma 73104 |
Arizona Oncology Associates, PC - CASA | Tucson, Arizona 85715 |
Florida Cancer Specialists - Colonial | Fort Myers, Florida 33905 |
Mercy Cancer Center at St. Anne | Toledo, Ohio 43623 |
Medical Oncology Associates, P.S. | Spokane, Washington 99208 |