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 - Tabular View

Tracking Information
First Received Date ^ICMJE	September 10, 2005
Last Updated Date	November 2, 2005
Start Date ^ICMJE	September 2005
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: September 13, 2005)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00179699 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 13, 2005)	To explore the anit-tumor activity of the combination of lenalidomide and pemetrexed when given to subjects with advanced NSCLC
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
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.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety Study
Condition ^ICMJE	Non-Small Cell Lung Cancer
Intervention ^ICMJE	Drug: CC-5013 Drug: pemetrexed
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	40
Completion Date	November 2006
Primary Completion Date
Eligibility Criteria ^ICMJE	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. 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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00179699
Responsible Party
Study ID Numbers ^ICMJE	CC-5013-NSCL-002
Study Sponsor ^ICMJE	Celgene Corporation
Collaborators ^ICMJE	Prologue Research International
Investigators ^ICMJE
Information Provided By	Celgene Corporation
Verification Date	October 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP