Back to resultsPhase II Study of Ridaforolimus (MK-8669) With Metastatic Bone or Soft-tissue Sarcoma Patients (MK-8669-030 AM1)
Primary Purpose
Sarcoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ridaforolimus
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoma
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ridaforolimus 40 mg
Arm Description
Outcomes
Primary Outcome Measures
Progression free rate (PFR) at 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
Full Information
NCT ID
NCT01010672
First Posted
November 6, 2009
Last Updated
April 29, 2015
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Ariad Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01010672
Brief Title
Phase II Study of Ridaforolimus (MK-8669) With Metastatic Bone or Soft-tissue Sarcoma Patients (MK-8669-030 AM1)
Official Title
A Phase II Study of MK-8669 When Administered as Maintenance Therapy to Japanese Patients With Metastatic Bone or Soft-tissue Sarcomas
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Ariad Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ridaforolimus 40 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ridaforolimus
Other Intervention Name(s)
MK-8669, AP23573, deforolimus; Ridaforolimus was also known as deforolimus until May 2009
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression free rate (PFR) at 6 months
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of Ridaforolimus (MK-8669) With Metastatic Bone or Soft-tissue Sarcoma Patients (MK-8669-030 AM1)
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