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A Study of Ganetespib in Subjects With ALK-Positive Non-Small-Cell Lung Cancer (NSCLC) (CHIARA)

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.
 
ClinicalTrials.gov Identifier: NCT01562015
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Ganetespib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : April 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ganetespib
Ganetespib IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval
 Drug: Ganetespib
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).


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: 1 year ]
  2. Disease Control Rate [ Time Frame: 6 weeks and 12 weeks ]
  3. Adverse events [ Time Frame: 1 year ]
  4. 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 ]
  5. Overall Survival [ Time Frame: 1 year ]

Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01562015


Locations
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United States, Florida
Synta Pharmaceuticals Investigative Site
Tampa, Florida, United States, 33612
United States, Ohio
Synta Pharmaceuticals Investigative Site
Cleveland, Ohio, United States, 44195
Canada, Ontario
Synta Pharmaceuticals Investigative Site
Hamilton, Ontario, Canada, ON L8V 5C2
Synta Pharmaceuticals Investigative Site
Ottawa, Ontario, Canada, K1H 8L6
Synta Pharmaceuticals Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
More Information
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Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT01562015    
Other Study ID Numbers: 9090-09
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms