An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer
Enchant
1 other identifier
interventional
51
8 countries
25
Brief Summary
The purpose of this study is to determine if ganetespib (STA-9090) is effective in the treatment of patients with HER2+ or triple negative breast cancer who have not received prior systemic treatment in the metastatic setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Jul 2012
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 9, 2012
CompletedFirst Posted
Study publicly available on registry
September 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedNovember 5, 2015
November 1, 2015
2.8 years
July 9, 2012
November 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate
Objective response rate is based on RECIST criteria
Week 12
Secondary Outcomes (1)
Duration of response and progression free survival
Every six weeks until progression
Study Arms (3)
HER2+ breast cancer
EXPERIMENTALTriple negative breast cancer
EXPERIMENTALClosed to enrollment
ER/PR+ Refractory to Prior Hormonal Treatment
EXPERIMENTALInterventions
Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.
Eligibility Criteria
You may qualify if:
- Pathologically confirmed diagnosis of invasive breast cancer.
- Stage IV disease.
- Documented HER2 and hormonal receptor status per protocol, ER/PR+ patients must be refractory to at least one prior hormonal treatment.
- ECOG Performance status 0-1.
- Measurable disease per RECIST (1.1).
- Adequate hematological function per protocol.
- Adequate hepatic function per protocol.
- Adequate renal function per protocol.
- Negative serum pregnancy test at study entry for patients of childbearing potential.
- Ability to understand and sign written consent and to comply with the study protocol.
You may not qualify if:
- Presence of active or untreated CNS metastases as determined by MRI/CT scan performed during screening.
- Active malignancies other than MBC within the last 5 years except adequately treated in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin.
- Bone as the only site of metastatic disease from breast cancer.
- Prior radiotherapy to the only area of measurable disease. NOTE: Radiotherapy to a limited area other than the sole site of measurable disease is allowed, if received prior to initiation of ganetespib treatment. Patients must have completed treatment and recovered from all acute treatment-related toxicities prior to administration of first dose of ganetespib.
- Pregnancy or lactation.
- Known serious cardiac illness.
- Uncontrolled intercurrent illness per protocol.
- Other severe acute or chronic medical condition or abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or that in the judgment of the investigator would make the patient inappropriate for entry into the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Synta Pharmaceuticals Investigative Site
Birmingham, Alabama, 35249, United States
Synta Pharmaceuticals Investigative Site
Altanta, Georgia, 30341, United States
Synta Pharmaceuticals Investigative Site
Boston, Massachusetts, 02111, United States
Synta Pharmaceuticals Investigative Site
New York, New York, 10065, United States
Synta Pharmaceuticals Investigative Site
Durham, North Carolina, 27710, United States
Synta Pharmaceuticals Investigative Site
Columbus, Ohio, 43210, United States
Synta Pharmaceuticals Investigative Site
Philadelphia, Pennsylvania, 19111-2497, United States
Synta Pharmaceutical Investigative Site
Houston, Texas, 77030, United States
Synta Pharmaceuticals Investigative Site
Córdoba, Argentina
Synta Pharmaceuticals Investigative Site
Rosario Santa Fe, S2000KZE, Argentina
Synta Pharmaceuticals Investigative Site
Brussels, B-1000, Belgium
Synta Pharmaceutical Investigative Site
Charleroi, 6000, Belgium
Synta Pharmaceuticals Investigative Site
Wilrijk, 2610, Belgium
Synta Pharmaceuticals Investigative Site
São Paulo, 01246, Brazil
Synta Pharmaceuticals Investigative Site
Lima, Peru
Synta Pharmaceutical Investigative Site
Seoul, Gangnam-GU, South Korea
Synta Pharmaceuticals Investigative Site
Seoul, Jongno-Gu, South Korea
Synta Pharmacuetical Investigative Site
Seoul, Seodaemun-GU, South Korea
Synta Pharmaceuticals Investigative Site
Seoul, Songpa-Gu, South Korea
Synta Pharmaceuticals Investigative Site
Barcelona, 08035, Spain
Synta Pharmaceutical Investigative Site
Edinburgh, EH4 2XU, United Kingdom
Synta Pharmaceutical Investigative Site
Glasgow, G12 0YN, United Kingdom
Synta Pharmaceutical Investigative Site
Nottingham, NG51PB, United Kingdom
Synta Pharmaceuticals Investigative Site
Oxford, OX3 9DU, United Kingdom
Synta Pharmaceutical Investigative Site
Peterborough, PE3 9GZ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2012
First Posted
September 3, 2012
Study Start
July 1, 2012
Primary Completion
April 1, 2015
Study Completion
August 1, 2015
Last Updated
November 5, 2015
Record last verified: 2015-11