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Phase 1 Study OF CDC-501 in Patients With Solid Tumors

NCT00046735 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-11-18

No results posted yet for this study

Summary

To identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment.

Conditions

  • Neoplasms

Interventions

DRUG

Lenalidomide

The planned doses for investigation are as follows: 5, 10, and 25 mg/day. Lenalidomide will be administered as a single daily dose for 4 weeks followed by a 2-week rest period. Dosing will be in the morning at approximately the same time each day, at least 1 hour before the morning meal. Patients will be assigned to dose level in the order of study entry. No dose adjustments or suspensions are allowed during the first cycle, except discontinuation for DLT

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Robert Knight, MD · Celgene Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-01
Primary Completion
2006-08-01
Completion
2006-09-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00046735 on ClinicalTrials.gov