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

NCT ID: NCT01010672

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2013-01-31

Brief Summary

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

Conditions

Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ridaforolimus 40 mg

Group Type: EXPERIMENTAL

Ridaforolimus

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

MK-8669, AP23573, deforolimus; Ridaforolimus was also known as deforolimus until May 2009

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ariad Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2009_688

Identifier Type: -

Identifier Source: secondary_id

MK-8669-030

Identifier Type: OTHER

Identifier Source: secondary_id

8669-030

Identifier Type: -

Identifier Source: org_study_id