Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Non-Small-Cell Lung
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.
Interventions
DRUGSalirasib
600mg BID until disease progression or unacceptable toxicity occurs.
Sponsors
Concordia Pharmaceuticals, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed