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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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