An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer

Breast Cancer Clinical Trial

— Enchant  

Official title:

An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677455
• Other study ID #: 9090-11
• Status: Completed
• Phase: Phase 2
• First received: July 9, 2012
• Last updated: November 4, 2015
• Start date: July 2012
• Est. completion date: August 2015

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• ER/Progressive Response (PR) + Refractory to Prior Hormonal Treatment
• HER-2 Positive Breast Cancer
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• ganetespib
Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Synta Pharmaceuticals Corp.

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Korea, Republic of,  Peru,  Spain,  United Kingdom, 

Outcome

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