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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
Sponsor:
Collaborator:
Ariad Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
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
 (submitted: January 23, 2013)
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
 (submitted: January 23, 2013)
  • Time to Tumor Progression [ Time Frame: Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years) ]
  • Progression Free Survival [ Time Frame: Day 1 to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years) ]
  • Overall Survival [ Time Frame: Day 1 to the date of death, or the date of last contact (up to 4 years) ]
  • Duration of Response [ Time Frame: Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years) ]
  • Number of participants experiencing adverse events [ Time Frame: From first dose up to 30 days after last dose (up to 1 year) ]
  • Number of participants who discontinued study drug due to adverse events [ Time Frame: From first dose up to the last dose (up to 1 year) ]
  • Mean ridaforolimus blood levels within 5 minutes post intravenous infusion [ Time Frame: Day 1 and Day 5 of Cycle 1 ]
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
Condition  ICMJE
  • Leiomyosarcoma
  • Liposarcoma
  • Osteosarcoma
  • Sarcoma, Soft Tissue
  • Metastases
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:
  • deforolimus (until May 2009)
  • AP23573
  • MK-8669
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
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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2011)
216
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
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:

  • Patients ≥15 years of age with metastatic and/or unresectable sarcomas of the following histological subgroups: Bone sarcomas, such as osteosarcoma and Ewings sarcoma; Leiomyosarcoma; Liposarcomas; Any other soft tissue sarcoma except gastrointestinal stromal tumors (GIST). Patients with well-differentiated liposarcoma or desmoid tumors must have demonstrated progressive disease within the previous 6 months
  • Presence of at least one measurable lesion that: Can be accurately measured in at least one dimension with longest diameter ≥20 mm using conventional techniques or ≥10 mm with spiral computerized tomography (CT) scan (or otherwise at least twice the reconstruction interval for CT or magnetic resonance imaging [MRI] scans)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Minimum life expectancy of 3 months
  • Adequate renal and hepatic function, as specified in the protocol
  • Adequate bone marrow function, as specified in the protocol
  • Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL
  • Male and female patients who are not surgically sterile or postmenopausal must agree to use reliable methods of birth control for the duration of the study until 30 days after the last dose of study drug
  • Able to understand and give written informed consent

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Presence of brain metastases
  • Prior therapy with rapamycin, rapamycin analogues or tacrolimus
  • Prior anticancer treatment (chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifiers, signal transduction inhibitors, etc) within 4 weeks prior to the first dose of ridaforolimus
  • Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of ≤ grade 1 by National Cancer Institute (NCI) toxicity criteria)
  • Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ)
  • Known or suspected hypersensitivity to drugs formulated with polysorbate 80 (Tween) or any other excipient contained in the study drug
  • Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin)
  • Significant uncontrolled cardiovascular disease
  • Active infection requiring systemic therapy
  • Known human immunodeficiency virus (HIV) infection
  • Treatment with any investigational agent within 4 weeks prior to the first dose of ridaforolimus
  • Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for 2 weeks prior to first planned dose of study drug
  • Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of ridaforolimus
  • Presence of any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluating the safety of the study drug
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Ariad Pharmaceuticals
Investigators  ICMJE Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date February 2015

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