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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.

Tracking Information
First Submitted Date  ICMJE March 14, 2012
First Posted Date  ICMJE March 23, 2012
Last Update Posted Date May 20, 2015
Study Start Date  ICMJE April 2012
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2012)
Objective response rate [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2012)
  • Duration of Response [ Time Frame: 1 year ]
  • Disease Control Rate [ Time Frame: 6 weeks and 12 weeks ]
  • Adverse events [ Time Frame: 1 year ]
  • 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 ]
  • Overall Survival [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Ganetespib in Subjects With ALK-Positive Non-Small-Cell Lung Cancer (NSCLC)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: Ganetespib
Ganetespib IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval
Intervention: Drug: Ganetespib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2015)
12
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2012)
100
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01562015
Other Study ID Numbers  ICMJE 9090-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Synta Pharmaceuticals Corp.
Study Sponsor  ICMJE Synta Pharmaceuticals Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Synta Pharmaceuticals Corp.
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP