Study of Salirasib to Treat Non-Small Cell Lung Cancer

NCT00531401 | Completed Phase 2

• 1 other identifier: CCA-FTS-201
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Salirasib DRUG

600mg BID until disease progression or unacceptable toxicity occurs.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Concordia Pharmaceuticals, Inc: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

farnesylthiosalicylic acid

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gregory J Riely, MD PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 17, 2007
• First Posted: September 18, 2007
• Study Start: September 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: June 9, 2011

Record last verified: 2011-06

Locations

US (1)