Solid Tumor
Conditions
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.
Interventions
DRUGridaforolimus
oral tablets, daily for 5 days/week
DRUGbevacizumab
IV infusion
Sponsors
Ariad Pharmaceuticals
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of recommended phase 2 dose of ridaforolimus in combination with bevacizumab | Duration of the trial |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed