A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC (Galaxy 2)

Synta Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: 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

Treatments: Drug: Docetaxel; Drug: Ganetespib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01798485

9090-14

2012-004349-34 (EudraCT Number)

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 patients with advanced non-small cell lung cancer.

Full description

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.

Update: An independent data monitoring committee (DMC) was established to review accumulating unblinded safety data, and efficacy data at two specified Interim Analyses. The DMC monitored the conduct of the trial (including the accrual/retention of patients) and reviewed the risks and benefits. The study was stopped after the first Interim Analysis due to futility.

The efficacy portion of this report is based on a 05 October 2015 data cut after the number of protocol-defined death events (336) for the first interim analysis had been achieved. The safety portion is based on the final database locked on 23 December 2015.

Enrollment: 696 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced Stage IIIB or IV non-small-cell lung cancer (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

• Epidermal growth factor receptor (EGFR) mutations
• Anaplastic lymphoma kinase (ALK) translocations
• Predominantly squamous, adenosquamous or unclear histologic type
• Active or untreated central nervous system (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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696 participants in 2 patient groups

Ganetespib and Docetaxel

Experimental group

Description:

Ganetespib (150 mg/m\^2) and docetaxel (75 mg/m\^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.

Treatment:

Drug: Docetaxel

Drug: Ganetespib

Docetaxel

Active Comparator group

Description:

Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.

Treatment:

Drug: Docetaxel