Text Size

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

This study is currently recruiting participants.
Verified May 2013 by Synta Pharmaceuticals Corp.
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT01562015
First received: March 14, 2012
Last updated: May 22, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Non Small Cell Lung Cancer
 Drug: Ganetespib
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Synta Pharmaceuticals Corp.:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of Response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Disease Control Rate [ Time Frame: 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562015

Contacts
Contact: Synta Pharmaceuticals clinicaltrials.gov call center 855 499-9664 9090-09_StudyInfo@syntapharma.com

Locations
United States, Florida
Synta Pharmaceuticals Investigative Site Not yet recruiting
Tampa, Florida, United States, 33612
United States, Michigan
Synta Pharmaceuticals Investigative Site Recruiting
Detroit, Michigan, United States, 48201
United States, Ohio
Synta Pharmaceuticals Investigative Site Not yet recruiting
Cleveland, Ohio, United States, 44195
Canada, Alberta
Synta Pharmaceuticals Investigative Site Recruiting
Calgary, Alberta, Canada, T2N 4N2
Synta Pharmaceuticals Investigative Site Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Synta Pharmaceuticals Investigative Site Recruiting
Hamilton, Ontario, Canada, ON L8V 5C2
Synta Pharmaceuticals Investigative Site Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Synta Pharmaceuticals Investigative Site Recruiting
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
  More Information

No publications provided

Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT01562015     History of Changes
Other Study ID Numbers: 9090-09
Study First Received: March 14, 2012
Last Updated: May 22, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013