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

NCT00781846 | Completed Phase 1

• 2 other identifiers: 8669-010AP23573-08-111
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Identification of recommended phase 2 dose of ridaforolimus in combination with bevacizumab

  Duration of the trial

Secondary Outcomes (2)

• 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

Study Arms (3)

1

EXPERIMENTAL

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

Drug: ridaforolimus; Drug: bevacizumab

2

EXPERIMENTAL

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

Drug: ridaforolimus; Drug: bevacizumab

3

EXPERIMENTAL

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

Drug: ridaforolimus; Drug: bevacizumab

Interventions

ridaforolimus DRUG

oral tablets, daily for 5 days/week

Also known as: deforolimus, AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009

1; 2; 3

bevacizumab DRUG

IV infusion

Also known as: avastin

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Ariad Pharmaceuticals: collaborator

Related Publications (1)

• 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.

  PMID: 23615181 RESULT

MeSH Terms

Interventions

ridaforolimus; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Frank Haluska, MD, PhD

  Ariad Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 29, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: February 13, 2015

Record last verified: 2015-02