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
Information source: Celgene Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Small Cell Lung Cancer
Intervention: CC-5013 (Drug); pemetrexed (Drug)
Phase: Phase 1
Status: Terminated
Sponsored by: Celgene Corporation
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.
Clinical Details
Official title: 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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety Study
Primary outcome: 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: To explore the anit-tumor activity of the combination of lenalidomide and pemetrexed when given to subjects with advanced NSCLC
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Subjects must understand and voluntarily sign an informed consent document.
2. Age >or= 18 years at the time of signing informed consent form.
3. Subjects must be able to adhere to the study visit schedule and other protocol
requirements.
4. Histological or cytologic documentation of advanced NSCLC.
5. Radiographic or clinical evidence of measurable advanced NSCLC. Subjects must have
measurable disease at least 2 cm in diameter.
6. Subjects must have been treated and progressed following chemotherapy.
7. ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).
8. 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:
1. Any of the following laboratory abnormalities:
1. Absolute neutrophil count (ANC) <1,500 cells/mm3 (1. 5 x 109/L)
2. Platelet count <100,000 cells/mm3 (100 x 109/L)
3. Serum creatinine >1. 5 mg/dL (133 mmol/L)
4. Serum SGOT/AST or SGPT/ALT >3. 0 x upper limit of normal (ULN)
5. Serum total bilirubin >or = 1. 5 mg/dL (26 mmol/L)
2. 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.
3. 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.
4. Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in
case of clinical suspicion of central nervous system involvement).
5. More than one prior chemotherapy for advanced NSCLC.
6. Concurrent use of any other anti-cancer agents.
7. Any prior use of lenalidomide.
8. Pregnant or lactating females.
9. Prior > or = to grade 3 rash or any desquamating (blistering) rash while taking
thalidomide.
10. Prior > or = to grade 3 allergic reaction/hypersensitivity to thalidomide.
11. Use of any standard/experimental anti-cancer drug therapy within 28 days of the
initiation of study drug therapy.
12. Known Hepatitis C.
Locations and Contacts
MD Anderson - Orlando, Orlando, Florida 32806, United States
University of Iowa, Iowa City, Iowa 52242, United States
Norton Healthcare, Louisville, Kentucky 40202, United States
Washington University, St. Louis, Missouri 63110, United States
North Shore Hem/Onc Associates, East Setauket, New York 11733-3456, United States
Additional Information
Starting date: September 2005
Ending date: November 2006
Last updated: November 2, 2005
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