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Lenalidomide and Gemcitabine as First-line Treatment in Patients With Pancreatic Cancer

NCT01547260 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-08-22

No results posted yet for this study

Summary

The purpose of this study is to ascertain whether treatment with lenalidomide or lenalidomide in combination with gemcitabine induces modulation of immune effector functions and to characterize the nature of immune functions.

Conditions

Interventions

DRUG

Gemzar

Gemcitabine (Gemzar®), 1000 mg/m2 in 0.9% sodium chloride will be administered as intravenous infusion over 30 minutes, weekly for 3 weeks then rest for 1 week (days 1, 8, 15 of each 28-day cycle).

DRUG

Revlimid

Lenalidomide capsules will be taken orally in the morning each day on days 1-21 of each 28-day cycle. Phase I; Three subjects will be enrolled into each dose cohort for 15, 20 and 25 mg/day, respectively. Phase II; Lenalidomide at dose determined in Phase I, will be administered orally once daily for 21 days followed by 7 days rest.

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • Celgene

    collaborator INDUSTRY

  • Maria Liljefors

    lead OTHER

Principal Investigators

  • Håkan Mellstedt, Prof. · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2014-01-31
Completion
2014-11-30

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases
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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 NCT01547260 on ClinicalTrials.gov