NCT00179699
Terminated
Phase 1
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
ConditionsNon-Small Cell Lung Cancer
Overview
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Celgene Corporation
- Enrollment
- 40
- Locations
- 5
- Primary Endpoint
- 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
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
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 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.
Outcomes
Primary Outcomes
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 Outcomes
- To explore the anit-tumor activity of the combination of lenalidomide and pemetrexed when given to subjects with advanced NSCLC
Investigators
Study Sites (5)
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