Study of Salirasib to Treat Non-Small Cell Lung Cancer
Phase 2
Completed
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- NCT00531401
- Lead Sponsor
- Concordia Pharmaceuticals, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States