- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00531401
Study of Salirasib to Treat Non-Small Cell Lung Cancer
June 8, 2011 updated by: Concordia Pharmaceuticals, Inc
Salirasib for Treatment of Advanced Non-Small Cell Lung Cancer: a Phase II Study
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
71
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10017
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gregory J Riely, MD PhD, Memorial Sloan Kettering Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
September 17, 2007
First Submitted That Met QC Criteria
September 17, 2007
First Posted (Estimate)
September 18, 2007
Study Record Updates
Last Update Posted (Estimate)
June 9, 2011
Last Update Submitted That Met QC Criteria
June 8, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Farnesylthiosalicylic acid
Other Study ID Numbers
- CCA-FTS-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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