A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma
18 Years
N/A
Both
Non-Small-Cell Lung Adenocarcinoma, Non-small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Metastatic
Trial Information
A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma
Preliminary signals of clinical activity of ganetespib as a single agent have been observed
in patients with advanced NSCLC. A Phase 2b/3 Study (9090-08) was initiated to evaluate the
safety and activity of ganetespib in combination with docetaxel vs. docetaxel alone in
NSCLC. Study 9090-08 is ongoing. Results from an interim analysis show that the combination
has been well tolerated and an encouraging improvement in efficacy, including overall
survival(OS) has been observed.
Inclusion Criteria:
- Stage IIIB or IV NSCLC
- Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1
- Prior therapy defined as 1 prior systemic therapy for advanced disease
- Documented disease progression during or following most first line therapy for
advanced disease
- Adequate hematologic, hepatic, renal function
Exclusion Criteria:
- Predominantly squamous, adenosquamous or unclear histologic type
- Active or untreated CNS metastases
- Active malignancies other than NSCLC within the last 5 years with the exception of
adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or
squamous cell carcinoma of the skin
- Serious cardiac illness or medical conditions
- Pregnant or lactating women
- Uncontrolled intercurrent illness
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
19 months
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
9090-14
NCT ID:
NCT01798485
Start Date:
March 2013
Completion Date:
April 2015
Related Keywords:
- Non-Small-Cell Lung Adenocarcinoma
- Non-small Cell Lung Cancer Stage IIIB
- Non-small Cell Lung Cancer Stage IV
- Non-small Cell Lung Cancer Metastatic
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| Synta Pharmaceuticals Investigative Site | Chicago, Illinois 60637 |
| Synta Pharmaceuticals Investigative Site | Winston-Salem, North Carolina 27103 |
