Oral Deforolimus With Trastuzumab for Patients With HER2-positive Trastuzumab-Refractory Metastatic Breast Cancer (8669-009)

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Sirolimus; Trastuzumab

Criteria

Inclusion Criteria:

• Female, 18 years of age or older

• Histologically confirmed HER2-positive metastatic breast cancer

• Trastuzumab-resistance

• Measurable disease, according to RECIST guidelines

• ECOG performance status less than or equal to 1

• Life expectancy greater than 3 months

• No prior treatment with temsirolimus, everolimus, rapamycin, or any other mTOR inhibitor

• At least 4 weeks must have lapsed between prior investigational therapy, chemotherapy or radiotherapy, and the first dose of ridaforolimus

• Left ventricular ejection greater than or equal to 50%

• Adequate cardiovascular function

• Adequate hematological, hepatic, and renal function

• Serum cholesterol less than or equal to 350 mg/dL and triglycerides less than or equal to 400 mg/dL

• Negative pregnancy test within 7 days prior to first dose of study drug and must use an approved contraceptive method from screening to 30 days after the last dose of study drug

• Availability and patient consent to obtain archival tissue samples

• Signed informed consent

Exclusion Criteria:

• Inadequate recovery from any prior surgical procedure or having undergone any major surgery within 2 weeks before trial entry

• Grade 1 or Grade 2 hypersensitivity reactions to prior trastuzumab therapy if these reactions prevented further trastuzumab administration

• Grade 3 or Grade 4 hypersensitivity reaction to prior trastuzumab

• Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest

• Known allergy to macrolide antibiotics

• Pregnant or breast-feeding

• Know history of HIV

• Diagnosis of brain metastasis or leptomeningeal carcinomatosis within 3 months

• Other malignancies within the past 3 years, except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin

• Active infection requiring prescription intervention

• Newly diagnosed or poorly controlled Type 1 or 2 diabetes

• Other concurrent illness which, in the Investigator's judgment, would either compromise the patient's safety or interfere with the evaluation of the safety of the study drug

• Concurrent treatment with medications that strongly induce or inhibit cytochrome P450.

• Any condition that renders patient unable to fully understand and provide informed consent and/or comply with the protocol