Clinical trial · Interventional
Study of Salirasib to Treat Non-Small Cell Lung Cancer
Salirasib for Treatment of Advanced Non-Small Cell Lung Cancer: a Phase II Study
NCT00531401CI-TRIAL-00004978completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Salirasib | Drug | Salirasib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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)
- timeFrame
- 10 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.