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Completed

NCT Number: NCT01031225

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

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).

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arizona Cancer Center; University of Arizona, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STA 9090

Drug

STA-9090 IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval

Primary outcomes

  1. Progression Free Survival rate

    Time frame: 16 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Synta Pharmaceuticals Corp.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Dec 14, 2009
Registry last updated
Sep 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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