Text Size

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
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
 Drug: Ridaforolimus
Drug: Dalotuzumab
Drug: Exemestane
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Exemestane
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 84
Study Start Date: July 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ridaforolimus 10 mg PO QD x5 + Dalotuzumab + Exemestane 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
Active Comparator: Ridaforolimus 30 mg PO QDx5 + Exemestane 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: Exemestane
25 mg PO QD
Other Name: Aromasin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01605396     History of Changes
Other Study ID Numbers: 8669-064
Study First Received: May 22, 2012
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Exemestane
Sirolimus
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 18, 2013