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NCT02285738 · ClinicalTrials.gov registry record · Early Phase 1
Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis
A Early Phase 1 study, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 17
- Enrollment target
NCT02285738 is a Early Phase 1 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 17 participants.
The verdict
NCT02285738, a Early Phase 1 study, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
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.
Interventions
- OTHER Observation
- DRUG Aspirin
- DRUG Simvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2014-12-30 |
| Est. Completion | 2018-10-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02285738
The ClinicalTrials.gov registry entry for NCT02285738 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Comprehensive Cancer Center, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Observation is the first listed.
NCT02285738 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02285738 about?
NCT02285738 is a clinical study titled "Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis". 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...
What is the current status of trial NCT02285738?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 17 participants. The study started on 2014-12-30. Estimated completion is 2018-10-01.
What interventions are being tested in trial NCT02285738?
The interventions under investigation include: Observation (OTHER), Aspirin (DRUG), Simvastatin (DRUG).
Who is sponsoring clinical trial NCT02285738?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
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