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A Phase I/II Study of Lenalidomide in Combination With Gemcitabine in Patients With Untreated Advanced Carcinoma of the Pancreas | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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

A Phase I/II Study Of Lenalidomide (Revlimid ) In Combination With Gemcitabine In Patients With Untreated Advanced Carcinoma Of The Pancreas

NCT00179751•Celgene Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects must understand and voluntarily sign an informed consent document.
•2. Age \>or = to 18 years at the time of signing informed consent form.
•3. Subjects must be able to adhere to the study visit schedule and other protocol requirements.
•4. Histological documentation of advanced pancreatic carcinoma not amenable to curative surgery or definitive radiation.
•5. Radiographic or clinical evidence of measurable advanced pancreatic carcinoma. Subjects must have measurable disease at least 2 cm in diameter.
•6. Subjects may have been previously treated with radiation therapy and 5-fluorouracil as a radiosensitizer in the adjuvant setting if they currently have evidence of progression.
•7. ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).
•8. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study medication.

Exclusion Criteria

•1. Any of the following laboratory abnormalities:
•1. Absolute neutrophil count (ANC) \<1,500 cells/mm3 (1.5 x 109/L)
•2. Platelet count \<100,000 cells/mm3 (100 x 109/L)
•3. Serum creatinine \>2.5 mg/dL (221 mmol/L)
•4. Serum SGOT/AST or SGPT/ALT \>3.0 x upper limit of normal (ULN)
•5. Serum total bilirubin \>2.0 mg/dL (34 mmol/L)
•2. Any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent.
•3. Prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the breast) unless the subject has been free of disease for \> or = to 1 year.
•4. Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
•5. Prior use of systemic therapy for the treatment of carcinoma of the pancreas with the exception of 5-fluorouracil as a radiosensitizer in the adjuvant setting.
+6 more criteria

Locations (6)

Cancer and Blood Institute

Metairie, Louisiana, United States

Bernard Cancer Center

St Louis, Missouri, United States

Case Western Reserve University Hospitals Ireland Cancer Center

Cleveland, Ohio, United States

Charleston Cancer Center

Charleston, South Carolina, United States

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

April 1, 2005

Completion Date

August 1, 2006

Last Updated

November 7, 2005

Enrollment

Estimated participants

Conditions

Pancreatic Cancer

Interventions

CC-5013

DRUG

gemcitabine

DRUG

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Advanced Malignant Solid NeoplasmLocally Advanced Pancreatic Carcinoma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

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