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

Phase 3TerminatedNCT01348126

Synta Pharmaceuticals Corp.385 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

385

Conditions

Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer Metastatic

Interventions

DocetaxelDRUG

75 mg/m2 administered on Day 1 of a 3-week treatment cycle by 1-hour intravenous infusion

Combination of ganetespib and docetaxelDRUG

Ganetespib 150 mg/m2 in combination with docetaxel 75 mg/m2. On Day 1 of each 3-week treatment cycle, ganetespib and docetaxel will be administered as separate 1-hour intravenous infusions. Ganetespib 150 mg/m2 will be administered again on Day 15 of each cycle.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (53)

Outcomes

Primary Outcomes

Progression-free survival in two co-primary populations

Time frame: 14 months

Secondary Outcomes

Overall Response Rate

ORR is the proportion of subjects who achieve tumor response

Time frame: 14 months

Determine qualitative and quantitative toxicities

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.

Time frame: 14 months

Determine plasma drug concentrations of the combination

Assessed via measurement of Cmax levels.

Time frame: 14 months

Evaluate Quality of Life

As measured by the EORTC QLQ -C30 questionnaire

Time frame: 14 months

Disease Control Rate

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.

Time frame: 14 months

Tumor size change

Tumor size changes from baseline to at least 6 and 12 weeks

Time frame: 14 months

Overall survival

Time frame: 21 months

Data from ClinicalTrials.gov

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