Phase II Study of Ridaforolimus (MK-8669) With Metastatic Bone or Soft-tissue Sarcoma Patients (MK-8669-030 AM1)
This study has been completed.
Information provided by (Responsible Party):
First received: November 6, 2009
Last updated: April 10, 2013
Last verified: April 2013
The study evaluates efficacy of Ridaforolimus when administered as maintenance therapy to patients with metastatic bone or soft-tissue sarcoma in Japan.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
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 ]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.
|Study Start Date:||November 2009|
|Study Completion Date:||January 2013|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
|Experimental: Ridaforolimus 40 mg||
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
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