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

This study has been completed.
Sponsor:
Collaborator:
Ariad Pharmaceuticals
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01010672
First received: November 6, 2009
Last updated: April 10, 2013
Last verified: April 2013
History of Changes

November 6, 2009
April 10, 2013
November 2009
September 2011   (final data collection date for primary outcome measure)
Progression free rate (PFR) at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Progression free rate (PFR) at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01010672 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Phase II Study of Ridaforolimus (MK-8669) With Metastatic Bone or Soft-tissue Sarcoma Patients (MK-8669-030 AM1)
A Phase II Study of MK-8669 When Administered as Maintenance Therapy to Japanese Patients With Metastatic Bone or Soft-tissue Sarcomas

The study evaluates efficacy of Ridaforolimus when administered as maintenance therapy to patients with metastatic bone or soft-tissue sarcoma in Japan.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sarcoma
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
Experimental: Ridaforolimus 40 mg
Intervention: Drug: Ridaforolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2013
September 2011   (final data collection date for primary outcome measure)

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
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01010672
8669-030, 2009_688, MK-8669-030
Yes
Merck
Merck
Ariad Pharmaceuticals
Study Director: Medical Monitor Merck
Merck
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP