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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)

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ClinicalTrials.gov Identifier: NCT01031225
Recruitment Status : Completed
First Posted : December 14, 2009
Last Update Posted : September 19, 2014
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: STA 9090 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: 1 Drug: STA 9090
STA-9090 IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval




Primary Outcome Measures :
  1. Progression Free Survival rate [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Objective Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival [ Time Frame: 18 months ]
  2. Safety and tolerability as measured by adverse event rates and laboratory evaluations [ Time Frame: 16 months ]


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:

  • 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

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): NCT01031225


  Show 21 Study Locations
Sponsors and Collaborators
Synta Pharmaceuticals Corp.

Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT01031225     History of Changes
Other Study ID Numbers: 9090-06
First Posted: December 14, 2009    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014

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

Additional relevant MeSH terms:
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