NCT02285738|CompletedEarly Phase 1DMCFDA Drug
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Sponsor study identifier
interventional
17
1 country
1
Study Start
December 30, 2014
Actual (reported)Primary Completion
July 17, 2017
Actual (reported)Study Completion
October 1, 2018
Actual (reported)This research study examines the safety and feasibility of aspirin with or without Simvastatin in solid tumor patients at risk for VTE (Venous Thromboembolism - or blood clots - in the arms, lets, lungs, or other part of the body). One-fifth of all thrombotic (clotting) events occur in patients that have cancer. Changes in sP-selectin will be used as a measure of efficacy. We have chosen sP-selectin as the primary marker because of its role in hemostasis, because it is predictive of thrombosis in cancer patients and because of promising preliminary data. We expect that sP-selectin levels will be elevated in patients before therapy with aspirin and/or statin, but that these levels will fall significantly during treatment, rise during the observation phase, and fall during the second study period. Patients who take part in the study have been diagnosed with a solid tumor cancer and are considered to be intermediate to high risk for VTE. The standard of care is to give chemotherapy for solid tumors and treat clots which develop using blood thinners.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 5, 2014
Actual (reported)November 7, 2014
Actual (reported)December 30, 2014
Actual (reported)July 17, 2017
Actual (reported)October 1, 2018
Actual (reported)Change in average sP-selectin levels
Change in sP-selectin levels as indicator of measure efficacy
at 16 weeks of treatment
Frequency of major bleeding complications or clinically significant non-bleeding complications per patient
at 17 weeks after beginning treatment
Change in average Platelet Factor 4
at 16 weeks of treatment
Change in average CD40 ligand
at 16 weeks of treatment
Change in average serum thromboxane B2
at 16 weeks of treatment
Change in average serum VEGF
at 16 weeks of treatment
Aspirin 81mg/day for 4 weeks followed by 2-week washout, followed by 4 weeks of Aspirin 81mg/day with daily dose of Simvastatin with a 2-week washout period, ending with 4 weeks of observation
Aspirin 81mg/day for 4 weeks followed by 2-week washout, followed by 4 weeks of observation with 2-week washout, ending with Aspirin 81mg/day with daily dose of Simvastatin
81mg/day for 4 weeks
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195, United States
Alok A Khorana, MD
Case Comprehensive Cancer Center
17 participants (actual enrollment reported by the registry).
First Submitted
November 5, 2014
First Posted
November 7, 2014
Study Start
December 30, 2014
Actual (reported)Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude
Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin followed by 2-week washout, followed by 4 weeks of observation with 2-week washout, ending with Aspirin 81mg/day
Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin followed by 2-week washout, followed by 4 weeks of Aspirin 81mg/day and a 2-week washout, ending with observation for 4 weeks.
Observation for 4 weeks with 2-week washout, followed by Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin followed by 2-week washout, ending with Aspirin 81mg/day for 4 weeks.
Observation for 4 weeks with 2-week washout, followed by Aspirin 81mg/day for 4 weeks followed by 2-week washout, ending with Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin.
Daily dose of Simvastatin for 4 weeks
participants will be observed for thrombotic evens for 4 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 17, 2017
Actual (reported)Study Completion
October 1, 2018
Actual (reported)Last Updated
May 8, 2019
Record last verified: 2019-05
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Source: ClinicalTrials.gov.
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