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Phase II Study of MK8669 With Metastatic Bone or Soft-tissue Sarcoma Patients
This study is currently recruiting participants.
Verified by Merck, June 2010
First Received: November 6, 2009   Last Updated: June 23, 2010   History of Changes
Sponsor: Merck
Collaborator: Ariad Pharmaceuticals
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT01010672
  Purpose

The study evaluates efficacy of MK 8669 when administered as maintenance therapy to patients with metastatic bone or soft-tissue sarcoma in Japan.


Condition Intervention Phase
Sarcoma
Drug: ridaforolimus
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Control: Uncontrolled
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of MK8669 When Administered as Maintenance Therapy to Patients With Metastatic Bone or Soft-tissue Sarcomas

Resource links provided by NLM:


Further study details as provided by Merck:

Primary Outcome Measures:
  • progression free rate (PFR) at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
ridaforolimus
Drug: ridaforolimus
MK8669 oral tablet, 40 mg once daily for 5 consecutive days followed by 2-day dosing holiday each week.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented histologic diagnosis of bone or soft-tissue sarcoma that has metastasized, and who derive benefit following chemotherapy.
  • 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010672

Locations
Japan, Chiyodaku
Merck Ltd., Japan Recruiting
Tokyo, Chiyodaku, Japan, 102-8667
Contact: Tadaaki Taniguchi     81-3-6272-1547        
Sponsors and Collaborators
Merck
Ariad Pharmaceuticals
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
ClinicalTrials.gov Identifier: NCT01010672     History of Changes
Other Study ID Numbers: 2009_688, MK8669-030
Study First Received: November 6, 2009
Last Updated: June 23, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on September 07, 2010