Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for early_phase_1

Timeline

Completed

Started Dec 2014

Longer than P75 for early_phase_1

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.8 years study duration

First Submitted

Initial submission to the registry

November 5, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed

2 months until next milestone

Study Start

First participant enrolled

December 30, 2014

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2017

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed

Last Updated

May 8, 2019

Status Verified

May 1, 2019

Enrollment Period

2.5 years

First QC Date

November 5, 2014

Last Update Submit

May 6, 2019

Conditions

Solid Tumor Cancer

Keywords

solid tumor, cancer, simvastatin, aspirin, blood clot, VTE, venous thromboembolism

Outcome Measures

Primary Outcomes (1)

Change in average sP-selectin levels
Change in sP-selectin levels as indicator of measure efficacy
at 16 weeks of treatment

Secondary Outcomes (13)

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
+8 more secondary outcomes

Study Arms (6)

Aspirin+Asprin/Simvastatin+Observation (ASO)

ACTIVE COMPARATOR

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