Breast Cancer Clinical Trial
— EnchantOfficial title:
An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer
Verified date | November 2015 |
Source | Synta Pharmaceuticals Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 51 |
Est. completion date | August 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Synta Pharmaceuticals Investigative Site | Cordoba | |
Argentina | Synta Pharmaceuticals Investigative Site | Rosario Santa Fe | |
Belgium | Synta Pharmaceuticals Investigative Site | Brussels | |
Belgium | Synta Pharmaceutical Investigative Site | Charleroi | |
Belgium | Synta Pharmaceuticals Investigative Site | Wilrijk | |
Brazil | Synta Pharmaceuticals Investigative Site | Sao Paulo | |
Korea, Republic of | Synta Pharmaceutical Investigative Site | Seoul | Gangnam-GU |
Korea, Republic of | Synta Pharmaceuticals Investigative Site | Seoul | Jongno-Gu |
Korea, Republic of | Synta Pharmaceuticals Investigative Site | Seoul | Songpa-Gu |
Korea, Republic of | Synta Pharmacuetical Investigative Site | Seoul | Seodaemun-GU |
Peru | Synta Pharmaceuticals Investigative Site | Lima | |
Spain | Synta Pharmaceuticals Investigative Site | Barcelona | |
United Kingdom | 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 States | Synta Pharmaceuticals Investigative Site | Altanta | Georgia |
United States | Synta Pharmaceuticals Investigative Site | Birmingham | Alabama |
United States | Synta Pharmaceuticals Investigative Site | Boston | Massachusetts |
United States | Synta Pharmaceuticals Investigative Site | Columbus | Ohio |
United States | Synta Pharmaceuticals Investigative Site | Durham | North Carolina |
United States | Synta Pharmaceutical Investigative Site | Houston | Texas |
United States | Synta Pharmaceuticals Investigative Site | New York | New York |
United States | Synta Pharmaceuticals Investigative Site | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Synta Pharmaceuticals Corp. |
United States, Argentina, Belgium, Brazil, Korea, Republic of, Peru, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate | Objective response rate is based on RECIST criteria | Week 12 | No |
Secondary | Duration of response and progression free survival | Progressive disease based on RECIST criteria. CT scans at week 6, week 12 and every 6 weeks thereafter for the duration of the study. | Every six weeks until progression | No |
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