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

February 12, 2015 updated by: Merck Sharp & Dohme LLC

A Phase I Trial of Oral Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, in Combination With Bevacizumab for Patients With Advanced Cancers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
30mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks
Drug: ridaforolimus
oral tablets, daily for 5 days/week
Other Names:
  • deforolimus
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009
Drug: bevacizumab
IV infusion
Other Names:
  • avastin
EXPERIMENTAL: 2
40mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks
Drug: ridaforolimus
oral tablets, daily for 5 days/week
Other Names:
  • deforolimus
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009
Drug: bevacizumab
IV infusion
Other Names:
  • avastin
EXPERIMENTAL: 3
40mg QDx5/wk ridaforolimus plus 15mg/kg Q3wks bevacizumab for 3 weeks
Drug: ridaforolimus
oral tablets, daily for 5 days/week
Other Names:
  • deforolimus
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009
Drug: bevacizumab
IV infusion
Other Names:
  • avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification of recommended phase 2 dose of ridaforolimus in combination with bevacizumab
Time Frame: Duration of the trial
Duration of the trial

Secondary Outcome Measures

Outcome Measure
Time Frame
Characterize the overall safety and tolerability of ridaforolimus in combination with bevacizumab
Time Frame: Duration of the study
Duration of the study
Description of the anti-tumor activity of ridaforolimus in combination with bevacizumab
Time Frame: Duration of the study
Duration of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Ariad Pharmaceuticals

Investigators

  • Study Director: Frank Haluska, MD, PhD, Ariad Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

October 28, 2008

First Submitted That Met QC Criteria

October 28, 2008

First Posted (ESTIMATE)

October 29, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 13, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8669-010
  • AP23573-08-111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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