A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma
Overview
- Phase
- Phase 3
- Intervention
- Docetaxel
- Conditions
- Non-Small-Cell Lung Adenocarcinoma
- Sponsor
- Synta Pharmaceuticals Corp.
- Enrollment
- 696
- Locations
- 203
- Primary Endpoint
- Overall Survival as of 19 October 2015
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Ganetespib and Docetaxel
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.
Intervention: Docetaxel
Ganetespib and Docetaxel
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.
Intervention: Ganetespib
Docetaxel
Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Intervention: Docetaxel
Outcomes
Primary Outcomes
Overall Survival as of 19 October 2015
Time Frame: up to 36 months
Overall survival (OS) was measured from the date of randomization to the date of death from any cause.
Secondary Outcomes
- Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015(up to 36 months)
- Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015(up to 36 months)
- Progression-free Survival (PFS) as of 19 October 2015(up to 36 months)
- Objective Response Rate (ORR) as of 19 October 2015(up to 36 months)
- Disease Control Rate (DCR) as of 19 October 2015(up to 36 months)
- Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015(up to 36 months)
- Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015(up to 36 months)
- Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015(up to 36 months)
- Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015(up to 36 months)
- Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015(up to 36 months)
- Participants With Treatment-Emergent Adverse Events as of 23 December 2015(up to 36 months)
- Patient-Reported Symptom Improvement as Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) Version 4 Test(Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial)
- Patient-Reported Quality of Life as Measured by the European Quality Of Life - Five Dimensions - Three Levels (EQ-5D-3L) Survey(Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial)