A Phase 2 Study Evaluating Ganetespib in Women With Metastatic HER2+ or Triple Negative Breast Cancer

This study is currently recruiting participants.

Verified May 2013 by Synta Pharmaceuticals Corp.

Sponsor:

Information provided by (Responsible Party):

Synta Pharmaceuticals Corp.

ClinicalTrials.gov Identifier:

NCT01677455

First received: July 9, 2012

Last updated: May 21, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 9, 2012

Last Updated Date

May 21, 2013

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Objective response rate [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Objective response rate is based on RECIST criteria

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01677455 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Duration of response and progression free survival [ Time Frame: Every six weeks until progression ] [ Designated as safety issue: No ]

Progressive disease based on RECIST criteria. CT scans at week 6, week 12 and every 6 weeks thereafter for the duration of the study.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Phase 2 Study Evaluating Ganetespib in Women With Metastatic HER2+ or Triple Negative Breast Cancer

Official Title ^ICMJE

An Open Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib(STA-9090) Monotherapy in Women With Previously Untreated Metastatic HER2 Positive or Triple Negative Breast Cancer

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Breast Cancer
HER-2 Positive Breast Cancer
Triple Negative Breast Cancer

Intervention ^ICMJE

Drug: ganetespib

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

Study Arm (s)

Experimental: HER2+ breast cancer
Intervention: Drug: ganetespib
Experimental: Triple negative breast cancer
Intervention: Drug: ganetespib

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2013

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Pathologically confirmed diagnosis of invasive breast cancer.
Stage IV disease.
Documented HER2 and hormonal receptor status per protocol.
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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Synta Pharmaceuticals ClinicalTrials.gov call center

855-499-9664

9090-11_StudyInfo@syntapharma.com

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT01677455

Other Study ID Numbers ^ICMJE

9090-11

Has Data Monitoring Committee

Responsible Party

Synta Pharmaceuticals Corp.

Study Sponsor ^ICMJE

Synta Pharmaceuticals Corp.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Synta Pharmaceuticals Corp.

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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