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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01010672
Collaborator
Ariad Pharmaceuticals (Industry)
50
Enrollment
1
Arm
38
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ridaforolimus 40 mg

Drug: 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.
Other Names:
  • MK-8669, AP23573, deforolimus; Ridaforolimus was also known as deforolimus until May 2009

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC
    • Ariad Pharmaceuticals

    Investigators

    • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT01010672
    Other Study ID Numbers:
    • 8669-030
    • 2009_688
    • MK-8669-030
    First Posted:
    Nov 10, 2009
    Last Update Posted:
    Apr 30, 2015
    Last Verified:
    Apr 1, 2015
    Additional relevant MeSH terms:
    Sarcoma
    Sirolimus

    Study Results

    No Results Posted as of Apr 30, 2015