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A Phase I/II Study of Lenalidomide in Combination With Gemcitabine in Patients With Untreated Advanced Carcinoma of the Pancreas

NCT00179751 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2005-11-07

No results posted yet for this study

Summary

Phase I will determine the MDT and evaluate the safety profile of oral lenalidomide days 1-21 and weekly gemcitabine days 1, 8, \& 15 in 28 day cycles Phase II will explore the anti-tumor activity and safety of the combination in subjects with advanced pancreatic carcinoma. Subjects will receive oral lenalidomide days 1-21 and weekly gemcitabine days 1, 8, \& 15 in 28 day cycles until documented disease progression occurs.

Conditions

Interventions

DRUG

CC-5013

DRUG

gemcitabine

Sponsors & Collaborators

  • Prologue Research International

    collaborator INDUSTRY

  • Celgene Corporation

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Completion
2006-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00179751 on ClinicalTrials.gov