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Completed

NCT Number: NCT01234857

A Study of Ridaforolimus (MK-8669) in Combination With Dalotuzumab (MK-0646) Compared to Standard of Care Treatment in Estrogen Receptor Positive Breast Cancer Patients (MK-8669-041 AM3)

This is a two-part study that will determine, if: 1) the combination of ridaforolimus and dalotuzumab will improve progression-free survival compared to exemestane; and 2) the combination of ridaforolimus and dalotuzumab will improve progression-free survival compared to both ridaforolimus and dalotuzumab as single agents, in participants with breast cancer.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The prospective participant must meet, at least, all of the criteria below to be eligible for study participation.

The participant:

  • Has a confirmed diagnosis of breast cancer that is metastatic or locally advanced and is estrogen receptor positive and human epidermal growth factor receptor 2 (HER-2) negative ;
  • Is post-menopausal;
  • Is at least 18 years of age;
  • Has a life expectancy of at least 3 months;
  • Has had a recurrence or progression of cancer after prior treatment and patient has received at least one line of endocrine therapy for metastatic disease, OR the patient's cancer has recurred within 6 months after the last dose of anastrozole or letrozole;
  • Has an available archival tumor specimen;
  • Has voluntarily agreed to participate by signing informed consent.

Exclusion criteria

If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation.

The participant:

  • Is receiving any other systemic tumor therapy;
  • Has previously received rapamycin or rapamycin analogs;
  • Has received prior treatment with insulin-like growth factor 1 receptor (IGF-1R) inhibitors, phosphoinositide 3-kinase (PI3K) inhibitors, or other experimental agents that target the PI3K, protein kinase B (AKT), or mammalian target of rapamycin (mTOR) pathways;
  • Has known allergy to macrolide antibiotics;
  • Has an active infection that requires antibiotics;
  • Has significant or uncontrolled cardiovascular disease;
  • Has poorly controlled Type 1 or 2 diabetes mellitus;
  • Is known to be human immunodeficiency virus (HIV) positive;
  • Has a known history of active Hepatitis B or C.

Treatment and study plan

Ridaforolimus + Dalotuzumab

Drug

Ridaforolimus 20 mg once daily (QD) five days a week, with the possibility of escalation to 30 mg once daily (QD) after the first cycle and dalotuzumab intravenous infusion 10 mg/kg once weekly (QW). Treatment will continue until disease progression.

Other names: MK-8669, MK-0646

Exemestane

Drug

Exemestane 25 mg daily (QD). Treatment will continue until disease progression. Patients may cross-over to the combination therapy after disease progression at the discretion of the investigator with Sponsor approval.

ridaforolimus

Drug

Ridaforolimus 40 mg QD five days a week. Treatment will continue until disease progression. Patients may cross-over to the combination therapy after disease progression at the discretion of the investigator with Sponsor approval. Note: the Sponsor-recommended dose of ridaforolimus when administered as a single agent is 40 mg/day, but when given in combination with dalotuzumab, it is given at 30 mg/day.

Other names: MK-8669

dalotuzumab

Drug

Dalotuzumab intravenous infusion 10 mg/kg QW. Treatment will continue until disease progression. Patients may cross-over to the combination therapy after disease progression at the discretion of the investigator with Sponsor approval.

Other names: MK-0646

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: Assessed every 8 weeks until documentation of disease progression or death.

    Progression free survival is defined as the time from randomization to progressive disease or death, which ever occurs earlier.

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: Assessed every 8 weeks until documentation of disease progression or death.

    Objective response rate (ORR) will be estimated by the proportion of patients who achieve partial response (PR) or complete response (CR) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

  2. Overall survival (OS)

    Time frame: Every 3 months after participants go off active treatment

    Overall survival is defined as the time from randomization to death due to any cause.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Two-Part Adaptive, Randomized Trial of Ridaforolimus in Combination With Dalotuzumab Compared to Exemestane or Compared to Ridaforolimus or Dalotuzumab Monotherapy in Estrogen Receptor Positive Breast Cancer Patients

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 4, 2010
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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