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Sponsors and Collaborators: |
Infinity Pharmaceuticals ICON Clinical Research |
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Information provided by: | Infinity Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00817362 |
The purpose of this study is to see if IPI-504 in combination with trastuzamab is an effective treatment in HER2 positive metastatic breast cancer
Condition | Intervention | Phase |
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Breast Cancer Advanced Breast Cancer Metastatic Breast Cancer Cancer of the Breast |
Drug: IPI-504 and Trastuzumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 92 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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IPI-504 and Trastuzumab: Experimental |
Drug: IPI-504 and Trastuzumab
IPI-504 IV infusion 300 mg/m2 once weekly in combination with trastuzumab infusion every 3 weeks. (Continuous schedule) Three week cycle with IPI-504 twice per week for 2 weeks and trastuzumab once per cycle followed by one week without treatment. Trastuzumab IV infusion 8 mg/kg as the first dose of trastuzumab, followed by trastuzumab 6 mg/kg every 3 weeks. Subjects whose last dose of trastuzumab was <4 weeks prior to study entry will receive 6 mg/kg as the first dose of trastuzumab. For all additional cycles in Stage 1, trastuzumab will be administered with the first dose of IPI-504. IPI-504 and trastuzumab will be administered for all cycles. Until progression or unacceptable toxicity develops. |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Organ and marrow function:
Exclusion Criteria:
United States, Florida | |
Lynn Cancer Institute, Boca Raton Community Hospital 800 Meadow Road | |
Boca Raton, Florida, United States, 33431 | |
Florida Cancer Research Institute | |
Davie, Florida, United States, 33328 |
Study Director: | Eduardo Rodenas, MD | Infinity Pharmaceuticals, Inc |
Responsible Party: | Infinity Pharmaceticals, Inc ( Eduardo Rodenas, MD ) |
Study ID Numbers: | IPI-504-07 |
Study First Received: | January 5, 2009 |
Last Updated: | July 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00817362 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Breast Cancer Advanced Breast Cancer Metastatic Breast Cancer HER2 Positive Breast Cancer |
Cancer of the breast Trastuzumab Herceptin |
Skin Diseases Trastuzumab Mitogens Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Antineoplastic Agents Therapeutic Uses |
Trastuzumab Breast Neoplasms Pharmacologic Actions Breast Diseases |