Study of Salirasib to Treat Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00531401
Recruitment Status : Completed
First Posted : September 18, 2007
Last Update Posted : June 9, 2011
Information provided by:
Concordia Pharmaceuticals, Inc

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Salirasib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Salirasib for Treatment of Advanced Non-Small Cell Lung Cancer: a Phase II Study
Study Start Date : September 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  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) [ Time Frame: 10 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00531401

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10017
Sponsors and Collaborators
Concordia Pharmaceuticals, Inc
Principal Investigator: Gregory J Riely, MD PhD Memorial Sloan Kettering Cancer Center

Responsible Party: Victor Bauer, Concordia Pharmaceutical Identifier: NCT00531401     History of Changes
Other Study ID Numbers: CCA-FTS-201
First Posted: September 18, 2007    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: June 2011

Keywords provided by Concordia Pharmaceuticals, Inc:
Non-Small-Cell Lung

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Farnesylthiosalicylic acid
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors