An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer
NCT ID: NCT01677455
Last Updated: 2015-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
51 participants
INTERVENTIONAL
2012-07-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HER2+ breast cancer
ganetespib
Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.
Triple negative breast cancer
Closed to enrollment
ganetespib
Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.
ER/PR+ Refractory to Prior Hormonal Treatment
ganetespib
Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.
Interventions
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ganetespib
Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Synta Pharmaceuticals Corp.
INDUSTRY
Responsible Party
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Locations
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Synta Pharmaceuticals Investigative Site
Birmingham, Alabama, United States
Synta Pharmaceuticals Investigative Site
Altanta, Georgia, United States
Synta Pharmaceuticals Investigative Site
Boston, Massachusetts, United States
Synta Pharmaceuticals Investigative Site
New York, New York, United States
Synta Pharmaceuticals Investigative Site
Durham, North Carolina, United States
Synta Pharmaceuticals Investigative Site
Columbus, Ohio, United States
Synta Pharmaceuticals Investigative Site
Philadelphia, Pennsylvania, United States
Synta Pharmaceutical Investigative Site
Houston, Texas, United States
Synta Pharmaceuticals Investigative Site
Córdoba, , Argentina
Synta Pharmaceuticals Investigative Site
Rosario Santa Fe, , Argentina
Synta Pharmaceuticals Investigative Site
Brussels, , Belgium
Synta Pharmaceutical Investigative Site
Charleroi, , Belgium
Synta Pharmaceuticals Investigative Site
Wilrijk, , Belgium
Synta Pharmaceuticals Investigative Site
São Paulo, , 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, , Spain
Synta Pharmaceutical Investigative Site
Edinburgh, , United Kingdom
Synta Pharmaceutical Investigative Site
Glasgow, , United Kingdom
Synta Pharmaceutical Investigative Site
Nottingham, , United Kingdom
Synta Pharmaceuticals Investigative Site
Oxford, , United Kingdom
Synta Pharmaceutical Investigative Site
Peterborough, , United Kingdom
Countries
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Other Identifiers
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9090-11
Identifier Type: -
Identifier Source: org_study_id
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