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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01605396
First received: May 22, 2012
Last updated: July 8, 2014
Last verified: July 2014

May 22, 2012
July 8, 2014
July 2012
February 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01605396 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Phase II Trial of Ridaforolimus and Exemestane, Compared to Ridaforolimus, Dalotuzumab and Exemestane in Participants With Breast Cancer (MK-8669-064 AM3)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Neoplasms
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
84
October 2014
February 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01605396
8669-064
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP