Phase II Study of Ridaforolimus (MK-8669) With Metastatic Bone or Soft-tissue Sarcoma Patients (MK-8669-030 AM1)

A Phase II Study of MK-8669 When Administered as Maintenance Therapy to Japanese Patients With Metastatic Bone or Soft-tissue Sarcomas

The study evaluates efficacy of Ridaforolimus when administered as maintenance therapy to patients with metastatic bone or soft-tissue sarcoma in Japan.

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