Phase I Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile Of Lenalidomide (Revlimid®, CC-5013) With Pemetrexed In Subjects With Advanced Non-Small Cell Lung Cancer

NCT00179699 | Terminated Phase 1

• 1 other identifier: CC-5013-NSCL-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

Study will deteremine the MTD and evaluate the safety profile of oral lenalidomide on days 1-14 when combined with pemetrexed on day 1 of a 21 days cycle. Subjects will continue on study until documention of disease progression.

Conditions

Non-Small Cell Lung Cancer

Keywords

cc-5013; Non Small Cell Lung Cancer; revlimid; celgene; cc5013

Outcome Measures

Primary Outcomes (1)

• To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral lenalidomide on days 1-14 and pemetrexed on day 1 every 21 days, as combination therapy to subjects with advanced Non-Small Cell Lung Cancer

Secondary Outcomes (1)

• To explore the anit-tumor activity of the combination of lenalidomide and pemetrexed when given to subjects with advanced NSCLC

Interventions

CC-5013 DRUG

pemetrexed DRUG

Eligibility Criteria

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

You may qualify if:

• Subjects must understand and voluntarily sign an informed consent document.
• Age \>or= 18 years at the time of signing informed consent form.
• Subjects must be able to adhere to the study visit schedule and other protocol requirements.
• Histological or cytologic documentation of advanced NSCLC.
• Radiographic or clinical evidence of measurable advanced NSCLC. Subjects must have measurable disease at least 2 cm in diameter.
• Subjects must have been treated and progressed following chemotherapy.
• ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).
• Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. 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) while on study drug.

You may not qualify if:

• Any of the following laboratory abnormalities:
• Absolute neutrophil count (ANC) \<1,500 cells/mm3 (1.5 x 109/L)
• Platelet count \<100,000 cells/mm3 (100 x 109/L)
• Serum creatinine \>1.5 mg/dL (133 mmol/L)
• Serum SGOT/AST or SGPT/ALT \>3.0 x upper limit of normal (ULN)
• Serum total bilirubin \>or = 1.5 mg/dL (26 mmol/L)
• Any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent.
• Prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the breast) unless the subject has been free of disease for \> 1 year.
• Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
• More than one prior chemotherapy for advanced NSCLC.
• Concurrent use of any other anti-cancer agents.
• Any prior use of lenalidomide.
• Pregnant or lactating females.
• Prior \> or = to grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
• Prior \> or = to grade 3 allergic reaction/hypersensitivity to thalidomide.

Sponsors & Collaborators

• Celgene Corporation: lead
• Prologue Research International: collaborator

Study Sites (5)

MD Anderson - Orlando

Orlando, Florida, 32806, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Norton Healthcare

Louisville, Kentucky, 40202, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

North Shore Hem/Onc Associates

East Setauket, New York, 11733-3456, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Lenalidomide; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 2005
• Study Completion: November 1, 2006
• Last Updated: November 7, 2005

Record last verified: 2005-10

Locations

US (5)