Oral Deforolimus With Trastuzumab for Patients With HER2-positive Trastuzumab-Refractory Metastatic Breast Cancer (8669-009)
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|ClinicalTrials.gov Identifier: NCT00736970|
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : August 27, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
This clinical trial will study the use of ridaforolimus 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 ridaforolimus in combination with trastuzumab have a positive response to the treatment, and if treatment with ridaforolimus in combination with trastuzumab prolongs survival.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Breast Neoplasms||Drug: ridaforolimus Drug: trastuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2008|
|Primary Completion Date :||January 2011|
|Study Completion Date :||May 2011|
10 mg oral tablets administered at 40 mg once daily for 5 consecutive days each week, followed by 2 days without ridaforolimus
10 mg oral tablets administered at 40 mg once daily for 5 consecutive days each week, followed by 2 days without ridaforolimus.
Other Names:Drug: trastuzumab
single intravenous infusion every week; initial dose of 4 mg/kg over 90 minutes, then 2 mg/kg over 30 minutes
Other Name: Herceptin
Primary Outcome Measures :
- Objective Response Rate (ORR) measured by modified RECIST guidelines [ Time Frame: Duration of the study ]
Secondary Outcome Measures :
- Characterize the overall safety and tolerability of oral deforolimus administered in combination with standard dose trastuzumab [ Time Frame: Duration of the study ]
- Evaluate the clinical-benefit response rate (CR or PR, or SD ≥ six 4-week cycles) [ Time Frame: Throughout the trial ]
- Evaluate additional efficacy endpoints, such as duration of response, time to tumor progression, progression-free survival, progression free survival rate, and overall survival [ Time Frame: Duration of the trial ]
- Perform exploratory molecular analyses [ Time Frame: Duration of the trial ]
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