Ridaforolimus in Treatment of Sarcoma-SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus)(8669-011 AM6)

This study has been completed.

Sponsor:

Collaborator:

Ariad Pharmaceuticals

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00538239

First received: September 28, 2007

Last updated: February 20, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	September 28, 2007
Last Updated Date	February 20, 2013
Start Date ^ICMJE	October 2007
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 20, 2013)	Progression-free Survival [ Time Frame: Up to 157 weeks after randomization ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: October 1, 2007)	Progression-free Survival
Change History	Complete list of historical versions of study NCT00538239 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 20, 2013)	Overall survival: First Analysis [ Time Frame: Up to 157 weeks after randomization ] [ Designated as safety issue: No ] Best Target Lesion Response (RECIST) [ Time Frame: Up to 157 weeks after randomization ] [ Designated as safety issue: No ] Overall Survival: Updated Analysis as of 30 April 2011 [ Time Frame: Up to 184 weeks after randomization ] [ Designated as safety issue: No ] Overall Survival: Updated Analysis as of 21 January 2012 [ Time Frame: Up to 222 weeks after randomization ] [ Designated as safety issue: No ] Safety and tolerability [ Time Frame: Up to 157 weeks after randomization ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: October 1, 2007)	Overall survival, antitumor response, change in cancer-related symptoms, safety, and tolerability.
Current Other Outcome Measures ^ICMJE (submitted: February 20, 2013)	Change in cancer-related symptoms [ Time Frame: Up to 157 weeks after randomization ] [ Designated as safety issue: No ]
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Ridaforolimus in Treatment of Sarcoma-SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus)(8669-011 AM6)
Official Title ^ICMJE	A Pivotal Trial to Determine the Efficacy and Safety of AP23573 When Administered as Maintenance Therapy to Patients With Metastatic Soft-Tissue or Bone Sarcomas
Brief Summary	The purpose of this study is to determine whether maintenance therapy with oral AP23573 (ridaforolimus), by preventing and controlling tumor growth for a prolonged period of time in patients with metastatic soft-tissue or bone sarcomas responding to chemotherapy, will result in clinically significant improvement in progression-free survival as compared to oral placebo.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Metastatic Soft-Tissue Sarcomas Metastatic Bone Sarcomas
Intervention ^ICMJE	Drug: ridaforolimus Four 10 mg tablets taken by mouth for 5 days per week continuously Other Names: deforolimus AP23573 MK-8669 ridaforolimus was also known as deforolimus until May 2009 Drug: Placebo Four 10 mg tablets taken by mouth for 5 days per week continuously
Study Arm (s)	Experimental: Ridaforolimus Intervention: Drug: ridaforolimus Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	711
Completion Date	December 2012
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Confirmed diagnosis of metastatic soft-tissue or bone sarcoma Ongoing complete response, partial response, or stable disease (RECIST) after a minimum of 4 cycles (and maximum of 12 months) of any one first, second, or third line of prior cytotoxic chemotherapy for metastatic disease Eastern Cooperative Oncology Group performance status of 0 or 1 Adequate organ and bone marrow function Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization Exclusion Criteria: Prior therapy with rapamycin or rapamycin analogs Ongoing toxicity associated with prior anticancer therapy Another primary malignancy within the past three years Concomitant medications that induce or inhibit CYP3A Significant, uncontrolled cardiovascular disease
Gender	Both
Ages	13 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00538239
Other Study ID Numbers ^ICMJE	MK-8669-011, AP23573-07-302
Has Data Monitoring Committee	Yes
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Ariad Pharmaceuticals
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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