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

Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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Trial Information

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

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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)

Outcome Time Frame:

10 weeks

Safety Issue:


Principal Investigator

Gregory J Riely, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2007

Completion Date:

November 2009

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021