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A Study of the HSP90 Inhibitor, STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)

This study is currently recruiting participants.
Verified May 2011 by Synta Pharmaceuticals Corp.
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT01031225
First received: November 16, 2009
Last updated: July 11, 2012
Last verified: May 2011
History of Changes
  Purpose

This is a phase 2 study of the HSP90 inhibitor, STA-9090 (ganetespib) in subjects with stage IIIB or IV non-small cell lung cancer (NSCLC).


Condition Intervention Phase
Non Small Cell Lung Cancer
 Drug: STA 9090
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Non-Randomized, Open-label, Multi-Center, Multi-Cohort Phase 2 Study Evaluating the Efficacy and Safety of STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer

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:
  • Progression Free Survival rate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Safety and tolerability as measured by adverse event rates and laboratory evaluations [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 88
Study Start Date: November 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: STA 9090
STA-9090 IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed diagnosis of Stage IIIB (with pleural effusion) or Stage IV NSCLC with measurable disease by RECIST and evidence of progression
  • Availability of tissue for analysis
  • ECOG Performance Status 0 or 1
  • Adequate organ function as defined in the protocol.
  • Must be at least 18 years old and able and willing to sign a written informed consent document

Exclusion Criteria:

  • Poor venous access requiring an indwelling catheter for study drug administration
  • Women who are pregnant or lactating
  • Ventricular ejection fraction < or = to 55% at baseline
  • Any uncontrolled intercurrent illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031225

Contacts
Contact: Kelly Maslin 781-541-7150 kmaslin@syntapharma.com
Contact: Amy Gauger 781-541-7985 agauger@syntapharma.com

  Show 21 Study Locations
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
  More Information

No publications provided

Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT01031225     History of Changes
Other Study ID Numbers: 9090-06
Study First Received: November 16, 2009
Last Updated: July 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Synta Pharmaceuticals Corp.:
Synta
STA 9090
ganetespib)
 Lung Cancer
Non Small Cell Lung Cancer
NSCLC

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 19, 2013