Know Cancer

or
forgot password

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
Open (Enrolling)
Both
Non Small Cell Lung Cancer

Thank you

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 SiteKettering, Ohio  45429
Synta Pharmaceuticals Investigative SiteTampa, Florida  33612
Synta Pharmaceuticals Investigative SiteDetroit, Michigan  48201