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| Sponsor: | 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: Lenalidomide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single-Center, Open-Label, Between-Patient, Dose-Escalation Phase 1 Study of CDC-501 In Patients With Solid Tumors |
| Enrollment: | 24 |
| Study Start Date: | June 2002 |
| Estimated Study Completion Date: | December 2009 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory tests within these ranges:
Exclusion Criteria
Contacts and Locations| United States, North Carolina | |
| Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Study Director: | Robert Knight, MD | Celgene Corporation |
More Information
| Responsible Party: | Robert Knight, VP Hematology, Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00046735 History of Changes |
| Other Study ID Numbers: | CC-5013-ST-003 |
| Study First Received: | October 2, 2002 |
| Last Updated: | September 30, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
solid tumors Revimid CC5013 CC-5013 |
|
Neoplasms Lenalidomide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |