Study of Salirasib to Treat Non-Small Cell Lung Cancer

Concordia Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Salirasib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00531401

CCA-FTS-201

Details and patient eligibility

About

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.

Enrollment

71 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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