NCT00179686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

December 20, 2006

Status Verified

December 1, 2006

First QC Date

September 10, 2005

Last Update Submit

December 19, 2006

Conditions

Non-Small Cell Lung Cancer

Keywords

celgenecc-5013NSCLCCC5013RevlimidNon-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

Interventions

CC-5013DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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/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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Birmingham Cancer Center

Birmingham, Alabama, 35294, United States

Location

Rush Cancer Institute

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Cancer and Blood Institute

Metairie, Louisiana, 70006, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 16, 2005

Study Start

March 1, 2005

Study Completion

July 1, 2006

Last Updated

December 20, 2006

Record last verified: 2006-12

Locations

US(6)