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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ganetespib

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

Group Type EXPERIMENTAL

Ganetespib

Intervention Type 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).

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No