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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 October 19, 2014
Carcinoma, Non-Small-Cell Lung
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Neoplasms by Site
Respiratory Tract Diseases
Physiological Effects of Drugs
Angiogenesis Modulating Agents
Molecular Mechanisms of Pharmacological Action
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