- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01562015
A Study of Ganetespib in Subjects With ALK-Positive Non-Small-Cell Lung Cancer (NSCLC) (CHIARA)
May 18, 2015 updated by: Synta Pharmaceuticals Corp.
A Single Arm, Phase 2 Study of Ganetespib in Subjects With Advanced Non-Small-Cell Lung Cancer With Anaplastic Lymphoma Kinase Gene Rearrangement (ALK-Positive NSCLC)
Phase 2 study of subjects with ALK positive, advanced NSCLC who have failed up to 3 prior therapies.
The study will take place globally at multiple study centers.
Subjects will be enrolled to receive ganetespib one time per week for three weeks followed by a rest week; and will repeat this schedule until the cancer gets worse or the subject is unable to tolerate ganetespib.
The primary goal of the study is to determine how ganetespib is tolerated and how active it is in ALK positive NSCLC.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
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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Ontario
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Hamilton, Ontario, Canada, ON L8V 5C2
- Synta Pharmaceuticals Investigative Site
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Ottawa, Ontario, Canada, K1H 8L6
- Synta Pharmaceuticals Investigative Site
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Toronto, Ontario, Canada, M5G 2M9
- Synta Pharmaceuticals Investigative Site
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Florida
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Tampa, Florida, United States, 33612
- Synta Pharmaceuticals Investigative Site
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Ohio
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Cleveland, Ohio, United States, 44195
- Synta Pharmaceuticals Investigative Site
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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:
- Males or females aged 18 years or older
- Pathological confirmation of advanced NSCLC
- Evidence of a translocation or an inversion event involving the ALK gene locus
- ECOG Performance Status 0 or 1
Exclusion Criteria:
- Prior therapy with ALK-targeted agents
- Prior treatment with Hsp90 inhibitor
- Known EGFR activating mutation
- Presence of active or untreated central nervous system (CNS) metastases
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ganetespib
Ganetespib IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval
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Ganetespib 200 mg/m2 administered 1 time per week for the first three weeks of a four week treatment cycle (Days 1, 8, and 15 of the 28 Day treatment cycle).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response rate
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: 1 year
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1 year
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Adverse events
Time Frame: 1 year
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1 year
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Duration of Response
Time Frame: 1 year
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1 year
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Disease Control Rate
Time Frame: 6 weeks and 12 weeks
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6 weeks and 12 weeks
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Progression Free Survival
Time Frame: From the date of study drug start until the date of first documented progression or date of death from any cause, whichever comes frist, assessed up to 3 years
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From the date of study drug start until the date of first documented progression or date of death from any cause, whichever comes frist, assessed up to 3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
April 1, 2012
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
March 14, 2012
First Submitted That Met QC Criteria
March 21, 2012
First Posted (Estimate)
March 23, 2012
Study Record Updates
Last Update Posted (Estimate)
May 20, 2015
Last Update Submitted That Met QC Criteria
May 18, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9090-09
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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