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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00179699
• Other study ID #: CC-5013-NSCL-002
• Status: Terminated
• Phase: Phase 1
• First received: September 10, 2005
• Last updated: November 2, 2005
• Start date: September 2005
• Est. completion date: November 2006

Study information

• Verified date: October 2005
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• CC-5013

• pemetrexed

Locations

Country	Name	City	State
United States	North Shore Hem/Onc Associates	East Setauket	New York
United States	University of Iowa	Iowa City	Iowa
United States	Norton Healthcare	Louisville	Kentucky
United States	MD Anderson - Orlando	Orlando	Florida
United States	Washington University	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Celgene Corporation	Prologue Research International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To explore the anit-tumor activity of the combination of lenalidomide and pemetrexed when given to subjects with advanced NSCLC