Clinical trial NCT01677455: An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer
Official title: An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
HER-2 Positive Breast Cancer
Triple Negative Breast Cancer
ER/Progressive Response (PR) + Refractory to Prior Hormonal Treatment
Keywords: Hsp90 inhibitor
ganetespib
STA 9090
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2012-09-03
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate
timeFrame: Week 12
Secondary outcomes:
measure: Duration of response and progression free survival
timeFrame: Every six weeks until progression
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Synta Pharmaceuticals Investigative Site
state: Alabama
city: Altanta
country: United States
facility: Synta Pharmaceuticals Investigative Site
state: Georgia
city: Boston
country: United States
facility: Synta Pharmaceuticals Investigative Site
state: Massachusetts
city: New York
country: United States
facility: Synta Pharmaceuticals Investigative Site
state: New York
city: Durham
country: United States
facility: Synta Pharmaceuticals Investigative Site
state: North Carolina
city: Columbus
country: United States
facility: Synta Pharmaceuticals Investigative Site
state: Ohio
city: Philadelphia
country: United States
facility: Synta Pharmaceuticals Investigative Site
state: Pennsylvania
city: Houston
country: United States
facility: Synta Pharmaceutical Investigative Site
state: Texas
city: Cordoba
country: Argentina
facility: Synta Pharmaceuticals Investigative Site
city: Rosario Santa Fe
country: Argentina
facility: Synta Pharmaceuticals Investigative Site
city: Brussels
country: Belgium
facility: Synta Pharmaceuticals Investigative Site
city: Charleroi
country: Belgium
facility: Synta Pharmaceutical Investigative Site
city: Wilrijk
country: Belgium
facility: Synta Pharmaceuticals Investigative Site
city: Sao Paulo
country: Brazil
facility: Synta Pharmaceuticals Investigative Site
city: Seoul
country: Korea, Republic of
facility: Synta Pharmaceutical Investigative Site
state: Gangnam-GU
city: Seoul
country: Korea, Republic of
facility: Synta Pharmaceuticals Investigative Site
state: Jongno-Gu
city: Seoul
country: Korea, Republic of
facility: Synta Pharmacuetical Investigative Site
state: Seodaemun-GU
city: Seoul
country: Korea, Republic of
facility: Synta Pharmaceuticals Investigative Site
state: Songpa-Gu
city: Lima
country: Peru
facility: Synta Pharmaceuticals Investigative Site
city: Barcelona
country: Spain
facility: Synta Pharmaceuticals Investigative Site
city: Edinburgh
country: United Kingdom
facility: Synta Pharmaceutical Investigative Site
city: Glasgow
country: United Kingdom
facility: Synta Pharmaceutical Investigative Site
city: Nottingham
country: United Kingdom
facility: Synta Pharmaceutical Investigative Site
city: Oxford
country: United Kingdom
facility: Synta Pharmaceuticals Investigative Site
city: Peterborough
country: United Kingdom
facility: Synta Pharmaceutical Investigative Site
Study officials:
References: