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

NCT ID: NCT00781846

Last Updated: 2015-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-02-28

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.

Conditions

Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

ridaforolimus

Intervention Type: DRUG

oral tablets, daily for 5 days/week

bevacizumab

Intervention Type: DRUG

IV infusion

2

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

Group Type: EXPERIMENTAL

ridaforolimus

Intervention Type: DRUG

oral tablets, daily for 5 days/week

bevacizumab

Intervention Type: DRUG

IV infusion

3

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

Group Type: EXPERIMENTAL

ridaforolimus

Intervention Type: DRUG

oral tablets, daily for 5 days/week

bevacizumab

Intervention Type: DRUG

IV infusion

Interventions

ridaforolimus

oral tablets, daily for 5 days/week

Intervention Type: DRUG

bevacizumab

IV infusion

Intervention Type: DRUG

Other Intervention Names

deforolimus; AP23573; MK-8669; ridaforolimus was also known as deforolimus until May 2009; avastin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ariad Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Haluska, MD, PhD

Role: STUDY_DIRECTOR

Ariad Pharmaceuticals

References

Nemunaitis J, Hochster HS, Lustgarten S, Rhodes R, Ebbinghaus S, Turner CD, Dodion PF, Mita MM. A phase I trial of oral ridaforolimus (AP23573; MK-8669) in combination with bevacizumab for patients with advanced cancers. Clin Oncol (R Coll Radiol). 2013 Jun;25(6):336-42. doi: 10.1016/j.clon.2013.02.005. Epub 2013 Apr 21.

Reference Type: RESULT

PMID: 23615181 (View on PubMed)

Other Identifiers

AP23573-08-111

Identifier Type: -

Identifier Source: secondary_id

8669-010

Identifier Type: -

Identifier Source: org_study_id