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

Non Small Cell Lung Cancer Clinical Trial

— CHIARA  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562015
• Other study ID #: 9090-09
• Status: Completed
• Phase: Phase 2
• First received: March 14, 2012
• Last updated: May 18, 2015
• Start date: April 2012
• Est. completion date: November 2014

Study information

• Verified date: May 2015
• Source: Synta Pharmaceuticals Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Canada	Synta Pharmaceuticals Investigative Site	Hamilton	Ontario
Canada	Synta Pharmaceuticals Investigative Site	Ottawa	Ontario
Canada	Synta Pharmaceuticals Investigative Site	Toronto	Ontario
United States	Synta Pharmaceuticals Investigative Site	Cleveland	Ohio
United States	Synta Pharmaceuticals Investigative Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Synta Pharmaceuticals Corp.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate		1 year	No
Secondary	Duration of Response		1 year	No
Secondary	Disease Control Rate		6 weeks and 12 weeks	No
Secondary	Adverse events		1 year	Yes
Secondary	Progression Free Survival		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	No
Secondary	Overall Survival		1 year	No