CC-4047 With Gemcitabine for Untreated Advanced Carcinoma of the Pancreas
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|ClinicalTrials.gov Identifier: NCT00540579|
Recruitment Status : Completed
First Posted : October 8, 2007
Results First Posted : March 13, 2013
Last Update Posted : March 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Pomalidomide Drug: Gemcitabine||Phase 1 Phase 2|
• 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of CC-4047 in Combination With Gemcitabine in Subjects With Untreated Advanced Carcinoma of the Pancreas|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||January 2011|
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-4047
1000 mg/m2 IV on days 1, 8, and 15 of 28 day cycle
Other Name: Gemzar
- 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 ]
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 ]The relative incidence of Grade 3/4 adverse events from protocol treatment as defined by Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|