Study of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Participants With Advanced Sarcoma (MK-8669-018 AM1)(COMPLETED)

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

A Phase II Study of AP23573, An mTOR Inhibitor, in Patients With Advanced Sarcoma

The purpose of this study is to assess the efficacy of ridaforolimus when administered once daily for 5 consecutive days (QDx5) every two weeks in participants with advanced sarcoma.

Study Overview

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 2

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

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients ≥15 years of age with metastatic and/or unresectable sarcomas of the following histological subgroups: Bone sarcomas, such as osteosarcoma and Ewings sarcoma; Leiomyosarcoma; Liposarcomas; Any other soft tissue sarcoma except gastrointestinal stromal tumors (GIST). Patients with well-differentiated liposarcoma or desmoid tumors must have demonstrated progressive disease within the previous 6 months
  • Presence of at least one measurable lesion that: Can be accurately measured in at least one dimension with longest diameter ≥20 mm using conventional techniques or ≥10 mm with spiral computerized tomography (CT) scan (or otherwise at least twice the reconstruction interval for CT or magnetic resonance imaging [MRI] scans)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Minimum life expectancy of 3 months
  • Adequate renal and hepatic function, as specified in the protocol
  • Adequate bone marrow function, as specified in the protocol
  • Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL
  • Male and female patients who are not surgically sterile or postmenopausal must agree to use reliable methods of birth control for the duration of the study until 30 days after the last dose of study drug
  • Able to understand and give written informed consent

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Presence of brain metastases
  • Prior therapy with rapamycin, rapamycin analogues or tacrolimus
  • Prior anticancer treatment (chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifiers, signal transduction inhibitors, etc) within 4 weeks prior to the first dose of ridaforolimus
  • Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of ≤ grade 1 by National Cancer Institute (NCI) toxicity criteria)
  • Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ)
  • Known or suspected hypersensitivity to drugs formulated with polysorbate 80 (Tween) or any other excipient contained in the study drug
  • Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin)
  • Significant uncontrolled cardiovascular disease
  • Active infection requiring systemic therapy
  • Known human immunodeficiency virus (HIV) infection
  • Treatment with any investigational agent within 4 weeks prior to the first dose of ridaforolimus
  • Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for 2 weeks prior to first planned dose of study drug
  • Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of ridaforolimus
  • Presence of any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluating the safety of the study drug

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ridaforolimus
12.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks
12.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks
Other Names:
  • AP23573
  • MK-8669
  • deforolimus (until May 2009)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Clinical Benefit Response (CBR) Using Response Criteria in Solid Tumors (RECIST)
Time Frame: Day 1 up to 4 years or discontinuation from study
Day 1 up to 4 years or discontinuation from study

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Tumor Progression
Time Frame: Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
Progression Free Survival
Time Frame: Day 1 to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
Day 1 to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
Overall Survival
Time Frame: Day 1 to the date of death, or the date of last contact (up to 4 years)
Day 1 to the date of death, or the date of last contact (up to 4 years)
Duration of Response
Time Frame: Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
Number of participants experiencing adverse events
Time Frame: From first dose up to 30 days after last dose (up to 1 year)
From first dose up to 30 days after last dose (up to 1 year)
Number of participants who discontinued study drug due to adverse events
Time Frame: From first dose up to the last dose (up to 1 year)
From first dose up to the last dose (up to 1 year)
Mean ridaforolimus blood levels within 5 minutes post intravenous infusion
Time Frame: Day 1 and Day 5 of Cycle 1
Day 1 and Day 5 of Cycle 1

Collaborators and Investigators

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

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.

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, 2004

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 30, 2004

First Submitted That Met QC Criteria

October 1, 2004

First Posted (Estimate)

October 4, 2004

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

Other Study ID Numbers

  • 8669-018
  • AP23573-04-202 (Other Identifier: Ariad Pharmaceuticals, Inc.)
  • 2004-002231-92 (EudraCT Number)

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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