A Phase 2 Multicenter Study Evaluating the Efficacy and Safety of IPI-504 in Combination With Trastuzumab in Patients With Pretreated, Locally Advanced or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer
Recent clinical data has demonstrated that even in heavily pretreated patients with
trastuzumab-refractory HER-2 positive breast cancer, targeting HER2 is efficacious.
IPI-504 is an HSP90 inhibitor and is chemically related to 17-AAG and it has been studied in
a clinical trial in combination with trastuzamab and a response rate of 26% (7/27) was
demonstrated in patients with pretreated, HER2-positive breast cancer. These data provide a
strong scientific rationale for clinical testing of IPI-504 plus trastuzumab in patients
with pretreated, locally advanced or metastatic HER2-positive breast cancer
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of the study is to evaluate overall response rate, safety, and tolerability of IPI-504 plus trastuzumab in patients with pretreated, locally advanced or metastatic HER2 positive breast cancer
After initial 20 patients are enrolled and treated for one cycle - if less that 33% of the subjects experience a dose limiting toxicity an additional 26 subjects will be enrolled
Yes
Pedro Santabarbara, MD
Study Director
Infinity Pharmaceuticals, Inc.
United States: Food and Drug Administration
IPI-504-07
NCT00817362
March 2009
May 2011
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Comprehensive Cancer Center at Desert Regional Medical Center | Palm Springs, California 92262 |
West Cancer Clinic | Memphis, Tennessee 38120 |
Weill Cornell Breast Center | New York, New York 10021 |
US Oncology | Houston, Texas 77060 |
Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3500 |
Peachtree Hematology-Oncology Consultants, P.C. | Atlanta, Georgia 30309 |
Florida Cancer Research Institute | Davie, Florida |
Boca Raton Comphrensive Cancer Care | Boca Raton, Florida 33431 |