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)
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer
Both
Non Small Cell Lung Cancer
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response rate
Outcome Time Frame:
1 year
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
9090-09
NCT ID:
NCT01562015
Start Date:
April 2012
Completion Date:
September 2015
Related Keywords:
- Non Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Synta Pharmaceuticals Investigative Site | Kettering, Ohio 45429 |
| Synta Pharmaceuticals Investigative Site | Tampa, Florida 33612 |
| Synta Pharmaceuticals Investigative Site | Detroit, Michigan 48201 |
