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

NCT ID: NCT00046735

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-01
• Study Completion Date: 2006-09-28

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.

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

Conditions

Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Lenalidomide

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patient must understand and voluntarily sign an informed consent document.

2. Age 18 years at the time of signing Informed Consent

3. Histologically or cytologically documented solid tumors that are refractory to standard/conventional therapy or for which no standard/conventional therapy exists.

4. Patients must have at least one measurable or non-measurable lesion according to the RECIST Criteria (Appendix I).

5. Patient has an ECOG (Zubrod) performance status of ≤ 2.

6. Approximate life expectancy greater than 3 months.

7. 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

8. The following prior treatments are allowable under this protocol:

9. 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

10. Hormonal therapy for cancer, if discontinued at least 4 weeks prior to treatment under this protocol

11. Other investigational drugs, if discontinued at least 4 weeks prior to treatment under this protocol

12. Surgery, if minor surgery occurred at least 2 weeks prior to treatment under this protocol, or at least 4 weeks since major surgery

13. Patient must be able to adhere to the study visit schedule and other protocol requirements.

14. 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

1. Myocardial infarction within the previous 6 months, unstable angina,symptomatic congestive heart failure, or other significant uncontrolled cardiac arrhythmia.

2. Cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or other significant thromboembolic event in the previous 6 months.

3. Active infection, including known human immunodeficiency virus (HIV) positivity or acquired-immunodeficiency-syndrome (AIDS)-related illness.

4. CNS metastases, unless controlled by previous radiation and the patient is neurologically stable.

5. 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.

6. Pregnant or nursing females.Female patients of childbearing potential who are unwilling to use reliable contraceptive methods.

7. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Knight, MD

Role: STUDY_DIRECTOR

Celgene Corporation

Locations

Wake Forest University

Winston-Salem, North Carolina, United States

Countries

United States

References

Miller AA, Case D, Harmon M, Savage P, Lesser G, Hurd D, Melin SA. Phase I study of lenalidomide in solid tumors. J Thorac Oncol. 2007 May;2(5):445-9. doi: 10.1097/01.JTO.0000268679.33238.67.

Reference Type: BACKGROUND

PMID: 17473661 (View on PubMed)

Other Identifiers

CC-5013-ST-003

Identifier Type: -

Identifier Source: org_study_id