Trial of Deforolimus in Combination With Bevacizumab for Patients With Advanced Cancers (8669-010)(COMPLETED)

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Ariad Pharmaceuticals
• Treatments: Bevacizumab; Sirolimus

Criteria

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