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

• Sponsor: Synta Pharmaceuticals Corp. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01562015
• Collaborator: (none)
• Enrollment: 12
• Locations: 5
• Arm: 1
• Duration (Months): 31
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: Ganetespib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ganetespib Ganetespib IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval	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).

Outcome Measures

Primary Outcome Measures

1. Objective response rate [1 year]

Secondary Outcome Measures

1. Duration of Response [1 year]

2. Disease Control Rate [6 weeks and 12 weeks]

3. Adverse events [1 year]

4. 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]

5. Overall Survival [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Synta Pharmaceuticals Investigative Site	Tampa	Florida	United States	33612
2	Synta Pharmaceuticals Investigative Site	Cleveland	Ohio	United States	44195
3	Synta Pharmaceuticals Investigative Site	Hamilton	Ontario	Canada	ON L8V 5C2
4	Synta Pharmaceuticals Investigative Site	Ottawa	Ontario	Canada	K1H 8L6
5	Synta Pharmaceuticals Investigative Site	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

• Synta Pharmaceuticals Corp.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Synta Pharmaceuticals Corp.
• ClinicalTrials.gov Identifier: NCT01562015
• Other Study ID Numbers: 9090-09
• First Posted: Mar 23, 2012
• Last Update Posted: May 20, 2015
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of May 20, 2015