Study of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Participants With Advanced Sarcoma (MK-8669-018 AM1)(COMPLETED)
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ClinicalTrials.gov Identifier: NCT00093080 |
Recruitment Status :
Completed
First Posted : October 4, 2004
Last Update Posted : February 13, 2015
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Sponsor:
Merck Sharp & Dohme LLC
Collaborator:
Ariad Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
Tracking Information | |||
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First Submitted Date ICMJE | September 30, 2004 | ||
First Posted Date ICMJE | October 4, 2004 | ||
Last Update Posted Date | February 13, 2015 | ||
Study Start Date ICMJE | October 2004 | ||
Actual Primary Completion Date | November 2008 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Number of participants with Clinical Benefit Response (CBR) Using Response Criteria in Solid Tumors (RECIST) [ Time Frame: Day 1 up to 4 years or discontinuation from study ] | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Study of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Participants With Advanced Sarcoma (MK-8669-018 AM1)(COMPLETED) | ||
Official Title ICMJE | A Phase II Study of AP23573, An mTOR Inhibitor, in Patients With Advanced Sarcoma | ||
Brief Summary | The purpose of this study is to assess the efficacy of ridaforolimus when administered once daily for 5 consecutive days (QDx5) every two weeks in participants with advanced sarcoma. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 | ||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: ridaforolimus
12.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks
Other Names:
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Study Arms ICMJE | Experimental: Ridaforolimus
12.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks
Intervention: Drug: ridaforolimus
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Publications * | Chawla SP, Staddon AP, Baker LH, Schuetze SM, Tolcher AW, D'Amato GZ, Blay JY, Mita MM, Sankhala KK, Berk L, Rivera VM, Clackson T, Loewy JW, Haluska FG, Demetri GD. Phase II study of the mammalian target of rapamycin inhibitor ridaforolimus in patients with advanced bone and soft tissue sarcomas. J Clin Oncol. 2012 Jan 1;30(1):78-84. doi: 10.1200/JCO.2011.35.6329. Epub 2011 Nov 7. Erratum in: J Clin Oncol. 2017 Aug 10;35(23):2722. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
216 | ||
Original Enrollment ICMJE |
176 | ||
Actual Study Completion Date ICMJE | November 2008 | ||
Actual Primary Completion Date | November 2008 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 15 Years and older (Child, Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Not Provided | ||
Removed Location Countries | France, United States | ||
Administrative Information | |||
NCT Number ICMJE | NCT00093080 | ||
Other Study ID Numbers ICMJE | 8669-018 AP23573-04-202 ( Other Identifier: Ariad Pharmaceuticals, Inc. ) 2004-002231-92 ( EudraCT Number ) |
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Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Merck Sharp & Dohme LLC | ||
Original Responsible Party | Not Provided | ||
Current Study Sponsor ICMJE | Merck Sharp & Dohme LLC | ||
Original Study Sponsor ICMJE | Ariad Pharmaceuticals | ||
Collaborators ICMJE | Ariad Pharmaceuticals | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Merck Sharp & Dohme LLC | ||
Verification Date | February 2015 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |