Study of Salirasib to Treat Non-Small Cell Lung Cancer
Completed · Phase 2
Conditions studied: Carcinoma, Non-Small-Cell Lung
In brief
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.
Key facts
- Study ID
- NCT00531401
- Run by
- Concordia Pharmaceuticals, Inc
- People needed
- 71
- Starts
- 2007-09-01
- Expected to finish
- 2009-11-01
- Last updated by the study team
- 2011-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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