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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CC-5013
Sponsored by
Celgene Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring celgene, cc-5013, NSCLC, CC5013, Revlimid, Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Birmingham Cancer Center
  • Rush Cancer Institute
  • University of Chicago
  • Cancer and Blood Institute
  • Fox Chase Cancer Center
  • MD Anderson Cancer Center

Outcomes

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.

Full Information

First Posted
September 10, 2005
Last Updated
December 19, 2006
Sponsor
Celgene Corporation
Collaborators
Prologue Research International
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1. Study Identification

Unique Protocol Identification Number
NCT00179686
Brief Title
A Study to Evaluate the Single-Agent Lenalidomide in Subjects With Recurrent Non-Small-Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Celgene Corporation
Collaborators
Prologue Research International

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
celgene, cc-5013, NSCLC, CC5013, Revlimid, Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CC-5013
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To evaluate the safety of lenalidomide monotherapy as treatment for subjects with recurrent non-small cell lung cancer.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Birmingham Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Rush Cancer Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Cancer and Blood Institute
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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