Study of Salirasib to Treat Non-Small Cell Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531401
• Other study ID #: CCA-FTS-201
• Status: Completed
• Phase: Phase 2
• First received: September 17, 2007
• Last updated: June 8, 2011
• Start date: September 2007
• Est. completion date: November 2009

Study information

• Verified date: June 2011
• Source: Concordia Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Salirasib
600mg BID until disease progression or unacceptable toxicity occurs.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Concordia Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes