Study of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Pa… (NCT00093080) | Clinical Trial Compass
CompletedPhase 2
Study of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Participants With Advanced Sarcoma (MK-8669-018 AM1)(COMPLETED)
216 participantsStarted 2004-10
Plain-language summary
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.
Who can participate
Age range15 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 trea…
What they're measuring
1
Number of participants with Clinical Benefit Response (CBR) Using Response Criteria in Solid Tumors (RECIST)
Timeframe: Day 1 up to 4 years or discontinuation from study