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Lenalidomide With Gemcitabine in Treatment of Untreated Advanced Carcinoma of the Pancreas

NCT00837031 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2013-03-13

Study results available
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Summary

To evaluate the 6-month overall survival, safety, and tolerability of lenalidomide in combination with standard gemcitabine as first-line treatment for patients with metastatic pancreatic cancer.

Conditions

Interventions

DRUG

Lenalidomide

The starting dose of lenalidomide for the lead-in portion will be 25 mg orally daily on Days 1-21, followed by a 7-day rest period (28-day cycle). If the 25-mg dose of lenalidomide is found to be intolerable or unsafe (i.e., if more than one of the 6 patients experience a DLT), then the dose will be reduced to 20 mg orally daily, and 6 additional patients will be treated. All patients will receive lenalidomide at the confirmed tolerable dose (either 25 mg or 20 mg given orally daily on Days 1-21 of a 28-day cycle) until disease progression. If the 20-mg daily dose is found to be intolerable or unsafe, enrollment will be put on hold.

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2 IV will be administered on Days 1, 8, and 15 for a 28-day cycle.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • Jeffrey R Infante, M.D. · SCRI Development Innovations, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-04-30
Completion
2012-06-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00837031 on ClinicalTrials.gov