CC-4047 With Gemcitabine for Untreated Advanced Carcinoma of the Pancreas
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of CC-4047 in Combination With Gemcitabine in Subjects With Untreated Advanced Carcinoma of the Pancreas|
- Determination of Maximum Tolerated Dose (MTD), The Dose of Study Drug(s) Which Causes <33% of Patients Treated to Experience Unacceptable Side Effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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.
- The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0 [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]The relative incidence of Grade 3/4 adverse events from protocol treatment as defined by Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
|Study Start Date:||November 2007|
|Study Completion Date:||January 2011|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
Phase 1: Subjects will be enrolled in dose-escalating cohorts to be treated with CC-4047 on days 1-21 Phase II: Subjects will be enrolled to receive oral CC-4047 at the MTD days 1 - 21
Other Name: CC-4047Drug: Gemcitabine
1000 mg/m2 IV on days 1, 8, and 15 of 28 day cycle
Other Name: Gemzar
• 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.
• To explore the anti-tumor activity of the combination of CC-4047 and gemcitabine as combination therapy in subjects with advanced pancreatic carcinoma.
• 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.
• To evaluate the safety profile of the combination of CC-4047 and gemcitabine as combination therapy in subjects with advanced pancreatic carcinoma.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540579
|United States, Colorado|
|University of Colorado Cancer Center|
|Aurora, Colorado, United States, 80045|
|United States, Tennessee|
|Tennessee Oncology, PLLC|
|Nashville, Tennessee, United States, 37023|
|Study Chair:||Jeffrey Infante, M.D.||SCRI Development Innovations, LLC|