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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01677455
Other study ID # 9090-11
Secondary ID
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


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
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