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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 Purpose

Non-Small Cell Lung Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CC-5013
pemetrexed
Sponsored by
Celgene Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring cc-5013, Non Small Cell Lung Cancer, revlimid, celgene, cc5013

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MD Anderson - Orlando
  • University of Iowa
  • Norton Healthcare
  • Washington University
  • North Shore Hem/Onc Associates

Outcomes

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

Full Information

First Posted
September 10, 2005
Last Updated
November 2, 2005
Sponsor
Celgene Corporation
Collaborators
Prologue Research International
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1. Study Identification

Unique Protocol Identification Number
NCT00179699
Brief 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
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 Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Terminated
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Celgene Corporation
Collaborators
Prologue Research International

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
cc-5013, Non Small Cell Lung Cancer, revlimid, celgene, cc5013

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CC-5013
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To explore the anit-tumor activity of the combination of lenalidomide and pemetrexed when given to subjects with advanced NSCLC

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
MD Anderson - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Norton Healthcare
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
North Shore Hem/Onc Associates
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733-3456
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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