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

Phase 2

Terminated

• Conditions: Non-small Cell Lung Cancer Stage IIIB; Non-small Cell Lung Cancer Stage IV; Non-small Cell Lung Cancer Metastatic
• Interventions: Drug: Combination of ganetespib and docetaxel; Drug: Docetaxel

• Registration Number: NCT01348126
• Lead Sponsor: Synta Pharmaceuticals Corp.

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 subjects with advanced non-small cell lung cancer.

Detailed 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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-02
• Study First Submitted QC: 2011-05-03
• Study First Posted: 2011-05-05
• Primary Completion: 2014-04
• Study Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-04
• Last Update Posted: 2015-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 385

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination of ganetespib and docetaxel	Combination of ganetespib and docetaxel	-
Single agent docetaxel	Docetaxel	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival in two co-primary populations	14 months

Secondary Outcome Measures

Name	Time	Method
Determine plasma drug concentrations of the combination	14 months	Assessed via measurement of Cmax levels.
Evaluate Quality of Life	14 months	As measured by the EORTC QLQ -C30 questionnaire
Determine qualitative and quantitative toxicities	14 months	AEs will be graded by NCI-CTC criteria. Tabulations of adverse events by frequency, relatedness and severity will be presented. Data will be presented by treatment arm and overall. No formal statistical analyses are planned.
Disease Control Rate	14 months	Disease Control Rate is defined as the proportion of patients with best response, according to modified RECIST 1.1, of CR, PR or SD, where the SD must be for at least 6 weeks or 12 weeks.
Overall Response Rate	14 months	ORR is the proportion of subjects who achieve tumor response
Tumor size change	14 months	Tumor size changes from baseline to at least 6 and 12 weeks
Overall survival	21 months

Trial Locations

Locations (4)

Synta Pharmaceuticals Investigative Site; 🇬🇧 London, United Kingdom

Synta Pharmaceuticals Investigational Site; 🇬🇧 Sutton, United Kingdom

Synta Pharmaceutials Investigative Site; 🇺🇸 Boston, Massachusetts, United States

Synta Pharmaceuticals Investgative Site; 🇧🇦 Sarajevo, Bosnia and Herzegovina