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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, HER-2 Positive Breast Cancer, Triple Negative Breast Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rate

Outcome Description:

Objective response rate is based on RECIST criteria

Outcome Time Frame:

Week 12

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

9090-11

NCT ID:

NCT01677455

Start Date:

July 2012

Completion Date:

October 2013

Related Keywords:

  • Breast Cancer
  • HER-2 Positive Breast Cancer
  • Triple Negative Breast Cancer
  • Hsp90 inhibitor
  • ganetespib
  • STA 9090
  • Breast Neoplasms

Name

Location

Synta Pharmaceuticals Investigative SiteAtlanta, Georgia  30322
Synta Pharmaceuticals Investigative SiteWinston-Salem, North Carolina  27103
Synta Pharmaceuticals Investigative SiteKettering, Ohio  45429
Synta Pharmaceuticals Investigative SiteBirmingham, Alabama  35249
Synta Pharmaceuticals Investigative SiteBoston, Massachusetts  02111
Synta Pharmaceuticals Investigative SiteNew York, New York  10065
Synta Pharmaceuticals Investigative SitePhiladelphia, Pennsylvania  19111-2497
Synta Pharmaceutical Investigative SiteHouston, Texas  77030