Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer (GALAXY)

Synta Pharmaceuticals

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Non-small Cell Lung Cancer Stage IIIB; Non-small Cell Lung Cancer Stage IV; Non-small Cell Lung Cancer Metastatic

Treatments: Drug: Docetaxel; Drug: Combination of ganetespib and docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01348126

9090-08

Details and patient eligibility

About

The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of subjects with advanced non-small cell lung cancer.

Full description

Preliminary signals of clinical activity of ganetespib as a single agent have been observed in NSCLC. A novel approach to treatment of NSCLC is the combination of Hsp90 inhibitors, such as ganetespib, and taxanes. Such combinations have shown potential for synergy in preclinical and clinical evaluations with other Hsp90 inhibitors. Preclinical studies with ganetespib and taxanes have indicated that the combination of these drugs was more effective than either drug alone at inducing cell death, and an ongoing phase 1 study indicates that the combination is well tolerated and warrants systematic evaluation in a larger study.

Enrollment: 385 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• confirmed diagnosis of NSCLC
• Stage IIIB or IV NSCLC
• ECOG Performance Status 0 or 1
• Prior therapy defined as 1 prior systemic therapy for advanced disease
• measurable disease
• Radiologic evidence of disease progression following most recent prior treatment.
• Adequate hematologic, hepatic, renal function

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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385 participants in 2 patient groups

Single agent docetaxel

Active Comparator group

Treatment:

Drug: Docetaxel

Combination of ganetespib and docetaxel

Experimental group

Treatment:

Drug: Combination of ganetespib and docetaxel