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

Synta Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Ganetespib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01562015

9090-09

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Ganetespib

Experimental group

Description:

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

Treatment:

Drug: Ganetespib