- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00093080
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
Status
Completed
Intervention / Treatment
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:
|
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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
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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