Study of Salirasib to Treat Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Concordia Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00531401
First received: September 17, 2007
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Salirasib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Salirasib for Treatment of Advanced Non-Small Cell Lung Cancer: a Phase II Study

Resource links provided by NLM:


Further study details as provided by Concordia Pharmaceuticals, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 71
Study Start Date: September 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Salirasib
    600mg BID until disease progression or unacceptable toxicity occurs.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531401

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

No publications provided

Responsible Party: Victor Bauer, Concordia Pharmaceutical
ClinicalTrials.gov Identifier: NCT00531401     History of Changes
Other Study ID Numbers: CCA-FTS-201
Study First Received: September 17, 2007
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

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
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 16, 2014