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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT01677455
First received: July 9, 2012
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
HER-2 Positive Breast Cancer
Triple Negative Breast Cancer
ER/Progressive Response (PR) + Refractory to Prior Hormonal Treatment
Drug: ganetespib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Synta Pharmaceuticals Corp.:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Objective response rate is based on RECIST criteria


Secondary Outcome Measures:
  • 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.


Enrollment: 51
Study Start Date: July 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677455

  Show 25 Study Locations
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
  More Information

No publications provided

Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT01677455     History of Changes
Other Study ID Numbers: 9090-11
Study First Received: July 9, 2012
Last Updated: September 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Synta Pharmaceuticals Corp.:
Hsp90 inhibitor
ganetespib
STA 9090

Additional relevant MeSH terms:
Triple Negative Breast Neoplasms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014