Phase II Study of Ridaforolimus (MK-8669) With Metastatic Bone or Soft-tissue Sarcoma Patients (MK-8669-030 AM1)
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|ClinicalTrials.gov Identifier: NCT01010672|
Recruitment Status : Completed
First Posted : November 10, 2009
Last Update Posted : April 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: Ridaforolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01010672
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|