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Sponsored by: |
MedImmune LLC |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00627627 |
To evaluate the antitumor activity following treatment with IPI-504 in patients with breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: IPI-504 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study |
Official Title: | A Phase 2, Open-Label, Single-Arm, Multicenter, Multinational Study to Evaluate the Antitumor Activity and Safety of IPI-504, A Novel Small Molecule Inhibitor of Heat Shock Protein 90(HSP90), in Patients With Locally Advanced or Metastatic Human Epidermal Growth Factor Receptor 2-Positive(HER2+) Breast Cancer That Has Progressed Despite Prior Her2=Targeted Therapy |
Estimated Enrollment: | 56 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
IPI-504
|
Drug: IPI-504
dose of 400 mg/m2 as a 30-60 minute IV infusion as part of a 21-day treatment cycle
|
To evaluate the antitumor activity following treatment with IPI-504 in patients with locally advanced or metastatic HER2+ breast cancer that has progressed despite prior HER2-targeted therapy.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Progression after treatment with at least 1 but not more than 3 regimens containing trastuzumab or lapatinib (treatment regimens that do not include trastuzumab or lapatinib do not qualify) for adjuvant, neoadjuvant, locally advanced, or metastatic disease with either one of the following stipulations:
Exclusion Criteria:
United States, District of Columbia | |
Georgetown Univ Medical Cntr, Lombardi Comprehensive Cancer Center, | |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Lynn Regional Cancer - West Campus | |
Boca Raton, Florida, United States, 33428 | |
Medical Specialists of the Palm Beaches | |
Lake Worth, Florida, United States, 33454 | |
United States, North Carolina | |
"Duke University Med Cntr Breast Oncology Research Program | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
University Hospitals Case Medical Center | |
Cleveland, Ohio, United States, 44122 | |
Cleveland Clinic Medical Center | |
Cleveland, Ohio, United States, 44195 | |
United States, South Carolina | |
Low County Hen/Onc | |
Mt. Pleasant, South Carolina, United States, 29464 |
Study Director: | David E. Weng, M.D., PhD | MedImmune LLC |
Responsible Party: | MedImmune Inc. ( David E. Weng, M.D., Ph. D. ) |
Study ID Numbers: | MI-CP153 |
Study First Received: | February 21, 2008 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00627627 |
Health Authority: | United States: Food and Drug Administration |
Skin Diseases Shock Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |