CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Pomalidomide +1 moredrug
Likely dose
Gemcitabine 1000 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00540579
NCT00540579Phase 2Completed
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A Phase I/II Study of CC-4047 in Combination With Gemcitabine in Subjects With Untreated Advanced Carcinoma of the Pancreas

SCRI Development Innovations, LLC·interventional·Posted Oct 8, 2007·Updated Mar 13, 2013

In Brief

A Phase 2 clinical trial evaluating Pomalidomide and Gemcitabine for Pancreatic Cancer. Completed, enrolled 23 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer
CountriesUnited States
CollaboratorsCelgene Corporation

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 8, 2007
Enrollment StartNov 1, 2007
Primary CompletionDec 1, 2008
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.7 years ago

Interventions

Pomalidomidedrug

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

Gemcitabinedrug

1000 mg/m2 IV on days 1, 8, and 15 of 28 day cycle