Study of Salirasib to Treat Non-Small Cell Lung Cancer

NCT ID: NCT00531401

Last Updated: 2011-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-11-30

Brief Summary

The purpose of this study is to determine whether Salirasib is effective to shrink or prevent the growth of the tumors associated with non-small cell lung cancer in both patients who are newly diagnosed or have recurrent disease.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Salirasib

600mg BID until disease progression or unacceptable toxicity occurs.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18 or older
• Non-Small Cell Lung Cancer not amenable to curative therapy with surgery or radiation
• Measurable disease
• Adenocarinoma of the lung, have not received prior chemotherapy for the malignancy and has a ≥ 15 pack year history of smoking; OR previously treated with recurrent disease and documented KRAS mutation
• Last dose of radiotherapy > 3 weeks prior to study entry and recovered from all acute toxicities associated with the prior therapy
• No history of another malignancy in the past 5 years except treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix
• Karnofsky Performance status of 70 or greater
• Body Weight > 50 kg
• Life expectancy ≥ 3 months
• Serum Creatinine ≤2.0 mg/dL, total bilirubin ≤ 2.0 mg/dL, ALT and AST ≤ 3x ULN, alkaline phosphatase ≤ 5x ULN, WBC > 3000/mm³, ANC ≥ 1500/mm³, platelets ≥ 100,000/mm³, hemoglobin ≥ 10g/dL.
• No coexisting cardiac or medical problems that would limit compliance in the study
• Willing to undergo blood sampling for pharmacokinetic analysis
• Negative pregnancy test, if applicable

Exclusion Criteria

• Evidence of active heart disease including myocardial infarction within previous 3 months
• Active infectious process
• Active central nervous system metastases (requiring increasing doses of corticosteroids over the prior month, known progressing lesions)
• Pregnant or lactating
• Major surgery without full recovery or major surgery within 3 weeks prior to treatment start
• QTc Interval > 470 msec
• Gastrointestinal tract disease resulting in inability to take or absorb oral medications

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Concordia Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Concordia Pharmaceutical

Principal Investigators

Gregory J Riely, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

CCA-FTS-201

Identifier Type: -

Identifier Source: org_study_id