A Study to Evaluate the Single-Agent Lenalidomide in Subjects With Recurrent Non-Small-Cell Lung Cancer

Sponsor

Celgene Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00179686

Collaborator

Prologue Research International (Industry)

Enrollment

Locations

Duration (Months)

6.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Subjects who qualify will receive single agent lenalidomide once daily on days 1-21 of 28 day cycles. Subjects will continue until disease progression is documented.

Condition or Disease	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer	Drug: CC-5013	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Single-Arm, Open-Label, Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid, CC-5013) in Subjects With Recurrent Non-Small Cell Lung Cancer

Study Start Date :

Mar 1, 2005

Study Completion Date :

Jul 1, 2006

Outcome Measures

Primary Outcome Measures

To determine the activity of lenalidiomide in recurrent non-small cell lung cancer. Activity will be assessed by measuring the response rate, tumor control rate, and time to tumor progression. []

Secondary Outcome Measures

To evaluate the safety of lenalidomide monotherapy as treatment for subjects with recurrent non-small cell lung cancer. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Understand and voluntarily sign an informed consent form.
Age >or = to 18 years at the time of signing the informed consent form
Able to adhere to the study visit schedule and other protocol requirements
Must have a histologically confirmed diagnosis of non small cell lung cancer that has recurred following at least two prior regimens. Those regimens must have contained both a platinum compound and a taxane either sequentially or in combination
Subjects must have measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (see Appendix II).
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.

WCBP must agree to have pregnancy tests every 4 weeks while on study drug (every 14 days for women with irregular cycles) and 4 weeks after the last dose of study drug.

Exclusion Criteria:

Any of the following laboratory abnormalities:
Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L)
Platelet count <100,000/mm3 (100 x 109/L)
Serum creatinine >2.5 mg/dL (221 mmol/L)
Serum SGOT/AST or SGPT/ALT >5.0 x upper limit of normal (ULN)
Serum total bilirubin >2.0 mg/dL (34 mmol/L)
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Prior history of malignancies other than non-small cell lung cancer (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for > or = to 1 year.
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or lactating females.
Prior > or = grade 3 allergic reaction/hypersensitivity to thalidomide.
Prior > or = grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
Prior use of lenalidomide.
Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham Cancer Center	Birmingham	Alabama	United States	35294
2	Rush Cancer Institute	Chicago	Illinois	United States	60612
3	University of Chicago	Chicago	Illinois	United States	60637
4	Cancer and Blood Institute	Metairie	Louisiana	United States	70006
5	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
6	MD Anderson Cancer Center	Houston	Texas	United States	77030