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

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT00046735

Collaborator

(none)

Enrollment

Location

Arm

51.9

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Drug: Lenalidomide	Phase 1

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Actual Study Start Date :

Jun 1, 2002

Actual Primary Completion Date :

Aug 1, 2006

Actual Study Completion Date :

Sep 28, 2006

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

To identify the MTD and safety of CDC-501 when given in a 6-wk cycle of daily administration of CDC-501 for 4 wks followed by a 2-wk rest in doses of 5 mg/day up to 25 mg/day in pts with solid tumors that are refractory after standard treatment. [6-week cycle comprising daily administration of CDC-501 for 4 weeks followed by a 2-week rest]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient must understand and voluntarily sign an informed consent document.
Age 18 years at the time of signing Informed Consent
Histologically or cytologically documented solid tumors that are refractory to standard/conventional therapy or for which no standard/conventional therapy exists.
Patients must have at least one measurable or non-measurable lesion according to the RECIST Criteria (Appendix I).
Patient has an ECOG (Zubrod) performance status of ≤ 2.
Approximate life expectancy greater than 3 months.
Laboratory tests within these ranges:

Absolute neutrophil count ≥ 1,500/μlL
Platelet count ≥100,000/μL
Serum creatinine ≤1.5 mg/dL
Total bilirubin ≤1.5 mg/dL
AST (SGOT)/ALT(SGPT) ≤ 2 x upper limit of normal (ULN) or ≤ 5 x ULN if hepatic metastases present

The following prior treatments are allowable under this protocol:
Radiation, if discontinued at least 4 weeks prior to treatment under this protocol Chemotherapy, if discontinued at least 4 weeks prior to treatment under this protocol, and at least 6 weeks prior to treatment under this protocol for prior nitrosurea or mitomycin-C treatment
Hormonal therapy for cancer, if discontinued at least 4 weeks prior to treatment under this protocol
Other investigational drugs, if discontinued at least 4 weeks prior to treatment under this protocol
Surgery, if minor surgery occurred at least 2 weeks prior to treatment under this protocol, or at least 4 weeks since major surgery
Patient must be able to adhere to the study visit schedule and other protocol requirements.
Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days prior to baseline. 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).

Exclusion Criteria

Myocardial infarction within the previous 6 months, unstable angina,symptomatic congestive heart failure, or other significant uncontrolled cardiac arrhythmia.
Cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or other significant thromboembolic event in the previous 6 months.
Active infection, including known human immunodeficiency virus (HIV) positivity or acquired-immunodeficiency-syndrome (AIDS)-related illness.
CNS metastases, unless controlled by previous radiation and the patient is neurologically stable.
Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from signing the informed consent or limit survival to less than 3 months.
Pregnant or nursing females.Female patients of childbearing potential who are unwilling to use reliable contraceptive methods.
Any condition, including the presence of laboratory abnormalities, which in the opinion of the Investigator places the patient at unacceptable risk if he/she were to participate in the study.