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

• ClinicalTrials.gov Identifier: NCT00179699
• Recruitment Status: Terminated
• First Posted: September 16, 2005
• Last Update Posted: November 7, 2005
• Sponsor: Celgene Corporation
• Collaborator: Prologue Research International
• Information provided by: Celgene

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-Small Cell Lung Cancer	Drug: CC-5013; Drug: pemetrexed	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: September 2005
• Study Completion Date: November 2006

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Subjects must understand and voluntarily sign an informed consent document.
2. Age >or= 18 years at the time of signing informed consent form.
3. Subjects must be able to adhere to the study visit schedule and other protocol requirements.
4. Histological or cytologic documentation of advanced NSCLC.
5. Radiographic or clinical evidence of measurable advanced NSCLC. Subjects must have measurable disease at least 2 cm in diameter.
6. Subjects must have been treated and progressed following chemotherapy.
7. ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).
8. 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.

Exclusion Criteria:

1. Any of the following laboratory abnormalities:

   1. Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L)
   2. Platelet count <100,000 cells/mm3 (100 x 109/L)
   3. Serum creatinine >1.5 mg/dL (133 mmol/L)
   4. Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
   5. Serum total bilirubin >or = 1.5 mg/dL (26 mmol/L)
2. 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.
3. 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.
4. Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
5. More than one prior chemotherapy for advanced NSCLC.
6. Concurrent use of any other anti-cancer agents.
7. Any prior use of lenalidomide.
8. Pregnant or lactating females.
9. Prior > or = to grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
10. Prior > or = to grade 3 allergic reaction/hypersensitivity to thalidomide.
11. Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
12. Known Hepatitis C.

Contacts and Locations

Locations

United States, Florida

MD Anderson - Orlando

Orlando, Florida, United States, 32806

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

United States, Kentucky

Norton Healthcare

Louisville, Kentucky, United States, 40202

United States, Missouri

Washington University

St. Louis, Missouri, United States, 63110

United States, New York

North Shore Hem/Onc Associates

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

Sponsors and Collaborators

Celgene Corporation

Prologue Research International

More Information

• ClinicalTrials.gov Identifier: NCT00179699
• Other Study ID Numbers: CC-5013-NSCL-002
• First Posted: September 16, 2005
• Last Update Posted: November 7, 2005
• Last Verified: October 2005

Keywords provided by Celgene:

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

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pemetrexed; Lenalidomide; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Immunologic Factors; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors