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Study of Lenalidomide and Docetaxel in Subjects With Androgen Independent Prostate Cancer

NCT01378091 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2016-05-09

No results posted yet for this study

Summary

Primary objectives:

To determine the maximum tolerated doses (MTDs) of daily lenalidomide and docetaxel given every three weeks and prednisone, as combination therapy to subjects with androgen independent prostate cancer

To evaluate the safety profile of the combination of daily lenalidomide and every three week docetaxel and prednisone when given to subjects with androgen independent prostate cancer

Secondary objective:

To explore the anti-tumor activity of the combination of daily lenalidomide and every 3 week docetaxel and prednisone when given to subjects with androgen independent prostate cancer.

Conditions

Interventions

DRUG

Lenalidomide

Supplied as 5 mg and 25 mg capsules. The lenalidomide dose levels to be studied include 10, 15, 20, 25, 30, 35 and 40 mg/day.

DRUG

Docetaxel

Docetaxel is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Doses of docetaxel to be studied include 60 and 75 mg/m2 once every three weeks.

DRUG

Prednisone

Prednisone is a synthetic corticosteroid drug that is particularly effective as an immunosuppressant drug. 5 mg BID daily.

Sponsors & Collaborators

Principal Investigators

  • Edward Gelmann, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT01378091 on ClinicalTrials.gov