A Phase II Trial of Ridaforolimus and Exemestane, Compared to Ridaforolimus, Dalotuzumab and Exemestane in Participants With Breast Cancer (MK-8669-064 AM3)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01605396

First received: May 22, 2012

Last updated: May 1, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	May 22, 2012
Last Updated Date	May 1, 2013
Start Date ^ICMJE	July 2012
Estimated Primary Completion Date	October 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 22, 2012)	Progression-free Survival (PFS) [ Time Frame: Baseline until disease progression, assessed throughout entire study duration (up to approximately 27 months) ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01605396 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 22, 2012)	Percent Reduction in Sum of Target Lesion Sizes [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ] Objective response rate (ORR) [ Time Frame: Baseline until participant no longer responds to treatment, assessed throughout entire study duration (up to approximately 27 months) ] [ Designated as safety issue: No ] Overall survival (OS) [ Time Frame: Baseline until death, assessed throughout entire study duration (up to approximately 27 months) ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Phase II Trial of Ridaforolimus and Exemestane, Compared to Ridaforolimus, Dalotuzumab and Exemestane in Participants With Breast Cancer (MK-8669-064 AM3)
Official Title ^ICMJE	A Phase II Randomized Trial of the Combination of Ridaforolimus and Exemestane, Compared to Ridaforolimus, Dalotuzumab and Exemestane in High Proliferation, Estrogen Receptor Positive Breast Cancer Patients
Brief Summary	The purpose of the study is to evaluate the progression free survival (PFS) of ridaforolimus, dalotuzumab and exemestane (R/D/E) compared to the combination of ridaforolimus and exemestane (R/E) in post-menopausal participants with breast cancer.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Breast Neoplasms
Intervention ^ICMJE	Drug: Ridaforolimus Participants receiving 10 mg PO (orally) QD (daily) of ridaforolimus in the triplet and 30 mg in the doublet may escalate to 20 mg QDx5 and 40 mg QDx5 respectively in the absence of grade 2 or above stomatitis in the initial cycle of treatment. Other Names: MK-8669 Deforolimus (until May, 2009) AP23573 Drug: Dalotuzumab 10 mg/kg/week intravenously. Note: Based upon evaluation of additional data the sponsor may adjust the starting dose of dalotuzumab, which may be changed to 7.5 mg/kg/week. Other Names: MK-0646 h7C10 Drug: Exemestane 25 mg PO QD Other Name: Aromasin
Study Arm (s)	Experimental: Ridaforolimus 10 mg PO QD x5 + Dalotuzumab + Exemestane Interventions: Drug: Ridaforolimus Drug: Dalotuzumab Drug: Exemestane Active Comparator: Ridaforolimus 30 mg PO QDx5 + Exemestane Interventions: Drug: Ridaforolimus Drug: Exemestane
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	84
Estimated Completion Date	October 2014
Estimated Primary Completion Date	October 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Females with a histologically confirmed diagnosis of breast cancer that is metastatic or locally advanced (locally advanced tumors must not be amenable to surgery or radiation therapy with curative intent) with the following pathological characteristics determined locally: estrogen receptor positive and Human Epidermal Growth Factor Receptor 2 (HER-2) negative, and Ki67 (a tumor marker) ≥ 15% determined by the central study laboratory Post-menopausal With advanced breast cancer whose disease was refractory to previous letrozole or anastrozole Has at least one confirmed measurable metastatic lesion Has a performance status ≤ 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale Has a life expectancy of at least 3 months Adequate organ function Exclusion Criteria: Is receiving any other concurrent systemic tumor therapy, including hormonal agents and HER-2 inhibitors Previously received rapamycin or rapamycin analogs, including ridaforolimus, temsirolimus, or everolimus Received prior treatment with Insulin-like Growth Factor 1 Receptor (IGF-1R) inhibitors, Phosphatidylinositol 3-Kinase (PI3K) inhibitors, or other experimental agents that target PI3K, Protein Kinase B (AKT), or Mammalian Target of Rapamycin (mTOR) pathway Is receiving chronic corticosteroids administered at doses greater than those used for normal replacement therapy Has active brain metastasis or leptomeningeal carcinomatosis; patients with adequately treated brain metastases are eligible if they meet certain criteria Known allergy to macrolide antibiotics Has an active infection requiring antibiotics Significant or uncontrolled cardiovascular disease Poorly controlled Type 1 or 2 diabetes Is known to be Human Immunodeficiency Virus (HIV) positive Has a known history of active hepatitis B or C. Healthy carriers of hepatitis B are not allowed on this study
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01605396
Other Study ID Numbers ^ICMJE	8669-064
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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