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

NCT00046735 | Completed Phase 1

• 1 other identifier: CC-5013-ST-003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Keywords

solid tumors; Revimid; CC5013; CC-5013

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

Drug: Lenalidomide

Interventions

Lenalidomide 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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• 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.

  PMID: 17473661 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Lenalidomide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Robert Knight, MD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2002
• First Posted: October 3, 2002
• Study Start: June 1, 2002
• Primary Completion: August 1, 2006
• Study Completion: September 28, 2006
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

US (1)