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

This study is ongoing, but not recruiting participants.

First Received: October 2, 2002 Last Updated: September 10, 2005 History of Changes

Sponsored by:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00046735

Purpose

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.

Condition	Intervention	Phase
Neoplasms	Drug: CC-5013	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title:	A Single-Center, Open-Label, Between-Patient, Dose-Escalation Phase 1 Study of CDC-501 In Patients With Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Estimated Enrollment:	24
Study Start Date:	June 2002
Estimated Study Completion Date:	December 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patient must understand and voluntarily sign an informed consent document.
Age 18 years at the time of signing Informed Consent.
Documented solid tumors that are refractory to standard/conventional therapy or for which no standard/conventional therapy exists.
Patient must be able to adhere to the study visit schedule and other protocol requirements.
Approximate life expectancy greater than 3 months.
Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. 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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046735

Locations

United States, North Carolina
Wake Forest University
Winston Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Celgene Corporation

More Information

No publications provided

Study ID Numbers:	CC-5013-ST-003
Study First Received:	October 2, 2002
Last Updated:	September 10, 2005
ClinicalTrials.gov Identifier:	NCT00046735 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

solid tumors
Revimid
CC5013
CC-5013

Study placed in the following topic categories:

Lenalidomide

Additional relevant MeSH terms:

Neoplasms
Antineoplastic Agents
Therapeutic Uses
Lenalidomide
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009