Study of Salirasib to Treat Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Salirasib for Treatment of Advanced Non-Small Cell Lung Cancer: a Phase II Study

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Salirasib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Salirasib|600mg BID until disease progression or unacceptable toxicity occurs.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of non-progression (as reflected in the tumor control rate of percent patients with CR+PR+SD) defined as the number of patients whose tumor did not progress (<20% tumor increase to total disappearance of tumor according to RECIST) |  | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Small-Cell Lung