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
This study has been terminated.
Prologue Research International
Information provided by:
First received: September 10, 2005
Last updated: November 2, 2005
Last verified: October 2005
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.
Non-Small Cell Lung Cancer
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- 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 Outcome Measures:
- To explore the anit-tumor activity of the combination of lenalidomide and pemetrexed when given to subjects with advanced NSCLC
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179699
|MD Anderson - Orlando
|Orlando, Florida, United States, 32806 |
|University of Iowa
|Iowa City, Iowa, United States, 52242 |
|Louisville, Kentucky, United States, 40202 |
|St. Louis, Missouri, United States, 63110 |
|North Shore Hem/Onc Associates
|East Setauket, New York, United States, 11733-3456 |
Prologue Research International
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 10, 2005
||November 2, 2005
||United States: Food and Drug Administration
Keywords provided by Celgene Corporation:
Non Small Cell Lung Cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 05, 2014
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
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