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

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Synta Pharmaceuticals Corp.

ClinicalTrials.gov Identifier:

NCT01348126

First received: May 2, 2011

Last updated: November 4, 2015

Last verified: November 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

May 2, 2011

Last Updated Date

November 4, 2015

Start Date ^ICMJE

May 2011

Primary Completion Date

April 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Progression-free survival in two co-primary populations [ Time Frame: 14 months ]

Original Primary Outcome Measures ^ICMJE

Progression free survival [ Time Frame: 14 months ]
Estimated median PFS of 4.5 months in the ganetespib treatment arm and 3 months in docetaxel alone arm
Overall survival in a subset of subjects with high baseline serum LDH [ Time Frame: 21 months ]
Estimated median OS of 8 months in the ganetespib treatment arm and 4 months in docetaxel alone arm

Change History

Complete list of historical versions of study NCT01348126 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall Response Rate [ Time Frame: 14 months ]
ORR is the proportion of subjects who achieve tumor response
Determine qualitative and quantitative toxicities [ Time Frame: 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.
Determine plasma drug concentrations of the combination [ Time Frame: 14 months ]
Assessed via measurement of Cmax levels.
Evaluate Quality of Life [ Time Frame: 14 months ]
As measured by the EORTC QLQ -C30 questionnaire
Disease Control Rate [ Time Frame: 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.
Tumor size change [ Time Frame: 14 months ]
Tumor size changes from baseline to at least 6 and 12 weeks
Overall survival [ Time Frame: 21 months ]

Original Secondary Outcome Measures ^ICMJE

Overall Response Rate [ Time Frame: 14 months ]
ORR is the proportion of subjects who achieve tumor response
Determine qualitative and quantitative toxicities [ Time Frame: 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.
Determine plasma drug concentrations of the combination [ Time Frame: 14 months ]
Assessed via measurement of Cmax levels.
Evaluate Quality of Life [ Time Frame: 14 months ]
As measured by the EORTC QLQ -C30 questionnaire
Clinical Benefit Rate [ Time Frame: 14 months ]
Clinical Benefit Rate is defined as best response of CR, PR and SD disease for at least 6 or 12 weeks
Mean tumor size change [ Time Frame: 14 months ]
Mean tumor size changes from baseline to at least 6 and 12 weeks

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Phase IIB/III Study of Ganetespib (STA-9090) in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Stage IIIb or IV Non-Small-Cell Lung Cancer

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 Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: Docetaxel
75 mg/m2 administered on Day 1 of a 3-week treatment cycle by 1-hour intravenous infusion
Drug: Combination of ganetespib and docetaxel
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.

Study Arms

Active Comparator: Single agent docetaxel
Intervention: Drug: Docetaxel
Experimental: Combination of ganetespib and docetaxel
Intervention: Drug: Combination of ganetespib and docetaxel

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

385

Completion Date

October 2015

Primary Completion Date

April 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Belgium, Bosnia and Herzegovina, Canada, Croatia, Czech Republic, Germany, Poland, Romania, Russian Federation, Serbia, Spain, United Kingdom, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01348126

Other Study ID Numbers ^ICMJE

9090-08

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Synta Pharmaceuticals Corp.

Study Sponsor ^ICMJE

Synta Pharmaceuticals Corp.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Synta Pharmaceuticals Corp.

Verification Date

November 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top