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A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma


Phase 3
18 Years
N/A
Open (Enrolling)
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

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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 SiteChicago, Illinois  60637
Synta Pharmaceuticals Investigative SiteWinston-Salem, North Carolina  27103