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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Solid Tumor

Treatments: Drug: ridaforolimus; Drug: bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00781846

8669-010

AP23573-08-111

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 3 patient groups

1

Experimental group

Description:

30mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks

Treatment:

Drug: bevacizumab

Drug: ridaforolimus

2

Experimental group

Description:

40mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks

Treatment:

Drug: bevacizumab

Drug: ridaforolimus

3

Experimental group

Description:

40mg QDx5/wk ridaforolimus plus 15mg/kg Q3wks bevacizumab for 3 weeks

Treatment:

Drug: bevacizumab

Drug: ridaforolimus