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

November 4, 2015 updated by: Synta Pharmaceuticals Corp.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina
        • Synta Pharmaceuticals Investigative Site
      • Rosario Santa Fe, Argentina, S2000KZE
        • Synta Pharmaceuticals Investigative Site
  • Belgium
      • Brussels, Belgium, B-1000
        • Synta Pharmaceuticals Investigative Site
      • Charleroi, Belgium, 6000
        • Synta Pharmaceutical Investigative Site
      • Wilrijk, Belgium, 2610
        • Synta Pharmaceuticals Investigative Site
  • Brazil
      • Sao Paulo, Brazil, 01246
        • Synta Pharmaceuticals Investigative Site
  • Korea, Republic of
    • Gangnam-GU
      • Seoul, Gangnam-GU, Korea, Republic of
        • Synta Pharmaceutical Investigative Site
    • Jongno-Gu
      • Seoul, Jongno-Gu, Korea, Republic of
        • Synta Pharmaceuticals Investigative Site
    • Seodaemun-GU
      • Seoul, Seodaemun-GU, Korea, Republic of
        • Synta Pharmacuetical Investigative Site
    • Songpa-Gu
      • Seoul, Songpa-Gu, Korea, Republic of
        • Synta Pharmaceuticals Investigative Site
  • Peru
      • Lima, Peru
        • Synta Pharmaceuticals Investigative Site
  • Spain
      • Barcelona, Spain, 08035
        • Synta Pharmaceuticals Investigative Site
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Synta Pharmaceutical Investigative Site
      • Glasgow, United Kingdom, G12 0YN
        • Synta Pharmaceutical Investigative Site
      • Nottingham, United Kingdom, NG51PB
        • Synta Pharmaceutical Investigative Site
      • Oxford, United Kingdom, OX3 9DU
        • Synta Pharmaceuticals Investigative Site
      • Peterborough, United Kingdom, PE3 9GZ
        • Synta Pharmaceutical Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Synta Pharmaceuticals Investigative Site
    • Georgia
      • Altanta, Georgia, United States, 30341
        • Synta Pharmaceuticals Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Synta Pharmaceuticals Investigative Site
    • New York
      • New York, New York, United States, 10065
        • Synta Pharmaceuticals Investigative Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Synta Pharmaceuticals Investigative Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Synta Pharmaceuticals Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Synta Pharmaceuticals Investigative Site
    • Texas
      • Houston, Texas, United States, 77030
        • Synta Pharmaceutical Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HER2+ breast cancer
Drug: ganetespib
Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.
EXPERIMENTAL: Triple negative breast cancer
Closed to enrollment
Drug: ganetespib
Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.
EXPERIMENTAL: ER/PR+ Refractory to Prior Hormonal Treatment
Drug: ganetespib
Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: Week 12
Objective response rate is based on RECIST criteria
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response and progression free survival
Time Frame: Every six weeks until progression
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synta Pharmaceuticals Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

July 9, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (ESTIMATE)

September 3, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 5, 2015

Last Update Submitted That Met QC Criteria

November 4, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9090-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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