A Phase I/II Study of CC-4047 in Combination With Gemcitabine in Subjects With Untreated Advanced Carcinoma of the Pancreas
Phase I
Primary:
• To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral
CC-4047 given on days 1-21 in combination with gemcitabine on days 1, 8, and 15 every 28
days in subjects with advanced pancreatic carcinoma.
Secondary:
• To explore the anti-tumor activity of the combination of CC-4047 and gemcitabine as
combination therapy in subjects with advanced pancreatic carcinoma.
Phase II
Primary:
• To explore the anti-tumor activity of the combination of CC-4047 on days 1-21 and
gemcitabine on days 1, 8, and 15 every 28 days in subjects with advanced pancreatic
carcinoma.
Secondary:
• To evaluate the safety profile of the combination of CC-4047 and gemcitabine as
combination therapy in subjects with advanced pancreatic carcinoma.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of Maximum Tolerated Dose (MTD), The Dose of Study Drug(s) Which Causes <33% of Patients Treated to Experience Unacceptable Side Effects
Unacceptable side effects or dose-limiting toxicities (DLTs) were defined as follows: Inability to Complete cycle 1 of therapy due to drug-related toxicity. > Grade 3 non-hematological drug-related toxicity (excluding alopecia) despite optimal supportive care Febrile neutropenia (absolute neutrophil count [ANC] <1,000/μL and fever >101° F (38.5° C)) Grade 4 neutropenia that occurs prior to day 21. (Grade 4 neutropenia that occurs after day 21 but resolves within 7 days of the scheduled cycle 2, will not be considered DLT) Platelet count < 25,000/μL Inability to initiate Cycle 2, Day 1 therapy within 7 days of scheduled start (i.e. cannot delay the start of Cycle 2 by more than 7 days following the normal 7 day recovery period) due to drug-related toxicity.
6 months
Yes
Jeffrey Infante, M.D.
Study Chair
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI GI 105
NCT00540579
November 2007
January 2011
Name | Location |
---|---|
University of Colorado Cancer Center | Denver, Colorado 80262 |
Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |