Phase II Study of Ridaforolimus (MK-8669) With Metastatic Bone or Soft-tissue Sarcoma Patients (MK-8669-030 AM1)
- Registration Number
- NCT01010672
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The study evaluates efficacy of Ridaforolimus when administered as maintenance therapy to patients with metastatic bone or soft-tissue sarcoma in Japan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Documented histologic diagnosis of bone or soft-tissue sarcoma that has metastasized, and who derive benefit following chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization
- Adequate organ and bone marrow function
Exclusion Criteria
- Presence of brain or central nervous system (CNS) metastases, unless successfully treated
- Prior therapy with rapamycin or rapamycin analogs
- Ongoing toxicity associated with prior anticancer therapy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ridaforolimus 40 mg Ridaforolimus -
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method