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Sponsors and Collaborators: |
Ariad Pharmaceuticals Merck |
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Information provided by: | Ariad Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00736970 |
This clinical trial will study the use of deforolimus in metastatic breast cancer subjects whose tumors have shown a resistance to trastuzumab (herceptin). The goal of this study is to find out if subjects treated with deforolimus in combination with trastuzumab have a positive response to the treatment, and if treatment with deforolimus in combination with trastuzumab prolongs survival.
Condition | Intervention | Phase |
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Breast Cancer Breast Neoplasms |
Drug: ridaforolimus Drug: trastuzumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | A Phase II Trial of Oral Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, in Combination With Trastuzumab for Patients With HER2-Positive Trastuzumab-Refractory Metastatic Breast Cancer |
Estimated Enrollment: | 37 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: ridaforolimus
10 mg oral tablets administered at 40 mg once daily for 5 consecutive days each week, followed by 2 days without deforolimus.
Drug: trastuzumab
single intravenous infusion every week; initial dose of 4 mg/kg over 90 minutes, then 2 mg/kg over 30 minutes
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Frank Haluska, MD, PhD | 617-494-0400 | Frank.Haluska@ariad.com |
United States, Florida | |
ARIAD Investigational Site #111 | Recruiting |
Fort Myers, Florida, United States, 33916 | |
United States, Illinois | |
ARIAD Investigational Site #109 | Recruiting |
Maryville, Illinois, United States, 62062 | |
United States, Louisiana | |
ARIAD Investigational Site #035 | Recruiting |
Metairie, Louisiana, United States, 70006 | |
United States, Tennessee | |
ARIAD Investigational Site #076 | Recruiting |
Nashville, Tennessee, United States, 37203 | |
ARIAD Investigational Site #112 | Recruiting |
Chattanooga, Tennessee, United States, 37404 | |
United States, Texas | |
ARIAD Investigational Site #106 | Withdrawn |
Dallas, Texas, United States, 75231 | |
ARIAD Investigational Site #113 | Recruiting |
Abilene, Texas, United States, 79606 | |
United States, Virginia | |
ARIAD Investigational Site #069 | Recruiting |
Richmond, Virginia, United States, 23230 | |
Chile | |
ARIAD Investigational Site #823, Instituto Clinico Oncologico del Sur (ICOS) | Recruiting |
Temuco, Chile, 01745 | |
Czech Republic | |
ARIAD Investigational Site #771, Fakultni nemocnice Olomouc | Recruiting |
Olomouc, Czech Republic, 77520 | |
ARIAD Investigational Site #717, Masarykuv onkogicky ustav | Recruiting |
Brno, Czech Republic, 65653 | |
ARIAD Investigational Site #770, Fakulni nemocnice Na Bulovce | Recruiting |
Praha 8, Czech Republic, 18001 | |
France, Ile-de-France | |
ARIAD Investigational Site #781, Institut Curie | Recruiting |
Paris, Ile-de-France, France, 75005 | |
France, Rhone-Alps | |
ARIAD Investigational Site #746, Centre Leon Berard | Recruiting |
Lyon, Rhone-Alps, France, 69373 |
Study Director: | Frank Haluska, MD, PhD | Ariad Pharmaceuticals |
Responsible Party: | ARIAD Pharmacueticals, Inc. ( Frank Haluska, MD, PhD, VP, Clinical Research ) |
Study ID Numbers: | AP23573-08-207 |
Study First Received: | August 14, 2008 |
Last Updated: | May 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00736970 History of Changes |
Health Authority: | United States: Food and Drug Administration |
deforolimus AP23573 breast cancer |
Skin Diseases Trastuzumab Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Antineoplastic Agents Therapeutic Uses |
Trastuzumab Breast Neoplasms Pharmacologic Actions Breast Diseases |