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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01010672
Recruitment Status : Completed
First Posted : November 10, 2009
Last Update Posted : April 30, 2015
Ariad Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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
Sarcoma Drug: Ridaforolimus Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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 : November 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Progression free rate (PFR) at 6 months [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01010672

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Ariad Pharmaceuticals
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01010672     History of Changes
Other Study ID Numbers: 8669-030
MK-8669-030 ( Other Identifier: protocol number )
First Posted: November 10, 2009    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs