Study of Salirasib to Treat Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Concordia Pharmaceuticals, Inc
• Treatments: Farnesylthiosalicylic acid; Salicylates

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