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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Sarcoma

Treatments: Drug: Ridaforolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01010672

2009_688

MK-8669-030 (Other Identifier)

8669-030

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Ridaforolimus 40 mg

Experimental group

Treatment:

Drug: Ridaforolimus