Oral Deforolimus With Trastuzumab for Patients With HER2-positive Trastuzumab-Refractory Metastatic Breast Cancer (8669-009)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: August 18, 2008
Last Update Posted: August 27, 2015
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.
|Breast Cancer Breast Neoplasms||Drug: ridaforolimus Drug: trastuzumab||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
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 ]
|Study Start Date:||July 2008|
|Study Completion Date:||May 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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
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