Trial of Deforolimus in Combination With Bevacizumab for Patients With Advanced Cancers (8669-010)(COMPLETED)
- Registration Number
- NCT00781846
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to assess the safety, tolerability, and recommended phase 2 dose of oral ridaforolimus administered in combination with intravenous bevacizumab in patients with advanced cancers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
- 18 years of age or older
- Advanced or metastatic solid tumor malignancy
- ECOG performance status of less than or equal to 1
- Life expectancy of greater than 3 months
- At least 4 weeks must have elapsed between prior investigational therapy, chemotherapy, or radiotherapy, and the first dose of deforolimus
- 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
- Signed informed consent
- Women of childbearing potential must have a negative serum pregnancy test within 7 days of starting therapy and must use an approved contraceptive method from time of screening until 30 days after the last dose of study drug
Exclusion Criteria
- Tumor location in close proximity to a major blood vessel
- History of brain metastases, spinal cord compression, or carcinomatous meningitis. Primary brain tumors (for example, glioblastoma) are allowed.
- New brain metastases, spinal cord compression, or leptomeningeal metastases on screening CT scan or MRI
- Hemoptysis or hematemesis within 28 days prior to entering the trial
- Clinical significant unexplained bleeding within 28 days prior to entering the trial
- Uncontrolled hypertension
- Proteinuria at screening
- Clinically significant cardiovascular disease
- Newly diagnosed or poorly controlled type 1 or 2 diabetes
- Active infection requiring prescribed intervention
- Other concurrent illness that, in the Investigator's judgement, would either compromise the patient's safety or interfere with the evaluation of the safety of the study drug
- Major surgery within 28 days before trial entry, or any incompletely healed surgical incision; minor surgery or procedures within 7 days
- Pregnant or breastfeeding
- Known allergy to macrolide antibiotics
- Known hypersensitivity to any component of bevacizumab
- Concurrent treatment with medications that strongly induce or inhibit cytochrome P450 (CYP3A)
- Known history of HIV sero-positivity
- Any condition in the Investigator's judgement that renders the patient unable to fully understand and provide informed consent and/or comply with the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 ridaforolimus 30mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks 1 bevacizumab 30mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks 2 bevacizumab 40mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks 2 ridaforolimus 40mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks 3 bevacizumab 40mg QDx5/wk ridaforolimus plus 15mg/kg Q3wks bevacizumab for 3 weeks 3 ridaforolimus 40mg QDx5/wk ridaforolimus plus 15mg/kg Q3wks bevacizumab for 3 weeks
- Primary Outcome Measures
Name Time Method Identification of recommended phase 2 dose of ridaforolimus in combination with bevacizumab Duration of the trial
- Secondary Outcome Measures
Name Time Method Characterize the overall safety and tolerability of ridaforolimus in combination with bevacizumab Duration of the study Description of the anti-tumor activity of ridaforolimus in combination with bevacizumab Duration of the study