Conditions: Pancreatic Cancer
Keywords: Pancreas Untreated Advanced Gemcitabine CC-4047
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 23
Healthy volunteers: no

Brief summary:
Because the activity of CC-4047 addresses numerous mechanisms of carcinoma growth inhibition - including, but not limited to anti-angiogenesis - CC-4047 has been selected for development as part of induction chemotherapy regimens for solid tumors. This study in pancreatic cancer is designed to determine the appropriate CC-4047 dose and regimen in combination with gemcitabine.

Detailed description:
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.

Arms:
arm 1: 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.

Interventions: intervention 1: Pomalidomide intervention 2: Gemcitabine
Intervention descriptions: intervention 1: 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 intervention 2: 1000 mg/m2 IV on days 1, 8, and 15 of 28 day cycle

Protocol document: