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

Stopped early · Phase 1

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00179699

Run by

Celgene Corporation

People needed

40

Starts

2005-09-01

Expected to finish

2006-11-01

Last updated by the study team

2005-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
• Known Hepatitis C.

Where it is running

• MD Anderson - Orlando — Orlando, Florida, United States
• University of Iowa — Iowa City, Iowa, United States
• Norton Healthcare — Louisville, Kentucky, United States
• Washington University — St Louis, Missouri, United States
• North Shore Hem/Onc Associates — East Setauket, New York, United States

Full record on ClinicalTrials.gov

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