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Completed

NCT Number: NCT01562015

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

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.

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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

Synta Pharmaceuticals Investigative Site, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ganetespib

Drug

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).

Primary outcomes

  1. Objective response rate

    Time frame: 1 year

Secondary outcomes

  1. Duration of Response

    Time frame: 1 year

  2. Disease Control Rate

    Time frame: 6 weeks and 12 weeks

  3. Adverse events

    Time frame: 1 year

  4. 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

  5. Overall Survival

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Synta Pharmaceuticals Corp.

Industry

Registry information

Official study 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)

Acronym: CHIARA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 23, 2012
Registry last updated
May 20, 2015

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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