Phase II Study of Ridaforolimus (MK-8669) With Metastatic Bone or Soft-tissue Sarcoma Patients (MK-8669-030 AM1)
Study Details
Study Description
Brief Summary
The study evaluates efficacy of Ridaforolimus when administered as maintenance therapy to patients with metastatic bone or soft-tissue sarcoma in Japan.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Ridaforolimus 40 mg
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Drug: Ridaforolimus
Ridaforolimus, oral tablet, 40 mg once daily for 5 consecutive days followed by 2-day dosing holiday each week. Participants treated until discontinuation criteria, such as progressive disease or unacceptable toxicity, were met.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Progression free rate (PFR) at 6 months [6 months]
Progression free rate at 6 months is defined as the proportion of participants who are a complete response (CR, disappearance of all target lesions), partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions) or stable disease (does not qualify for PR or progressive disease) at 6 months from the date of the first study drug administration.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Documented histologic diagnosis of bone or soft-tissue sarcoma that has metastasized, and who derive benefit following chemotherapy.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization
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Adequate organ and bone marrow function
Exclusion Criteria:
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Presence of brain or central nervous system (CNS) metastases, unless successfully treated
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Prior therapy with rapamycin or rapamycin analogs
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Ongoing toxicity associated with prior anticancer therapy
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History or current evidence of any clinically significant disease that might confound the results of the study, complicate the interpretation of the study results, interfere with the patient's participation, or pose an additional risk to the patient
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Merck Sharp & Dohme LLC
- Ariad Pharmaceuticals
Investigators
- Study Director: Medical Monitor, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 8669-030
- 2009_688
- MK-8669-030