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

July 9, 2012
September 18, 2014
July 2012
February 2015   (final data collection date for primary outcome measure)
Objective response rate [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Objective response rate is based on RECIST criteria
Same as current
Complete list of historical versions of study NCT01677455 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer
An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • HER-2 Positive Breast Cancer
  • Triple Negative Breast Cancer
  • ER/Progressive Response (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.
  • Experimental: HER2+ breast cancer
    Intervention: Drug: ganetespib
  • Experimental: Triple negative breast cancer
    Closed to enrollment
    Intervention: Drug: ganetespib
  • Experimental: ER/PR+ Refractory to Prior Hormonal Treatment
    Intervention: Drug: ganetespib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
51
May 2015
February 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   United Kingdom,   Korea, Republic of,   United States,   Argentina,   Brazil,   Peru,   Spain
 
NCT01677455
9090-11
No
Synta Pharmaceuticals Corp.
Synta Pharmaceuticals Corp.
Not Provided
Not Provided
Synta Pharmaceuticals Corp.
September 2014

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