NCT02285738

Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis

Completed EARLY_PHASE1 Last updated 8 May 2019

What this trial tests

EARLY_PHASE1 trial testing Aspirin in Solid Tumor in 17 participants. Completed in 1 October 2018.

Timeline

30 December 2014

Primary endpoint
17 July 2017

1 October 2018

Quick facts

Lead sponsor	Case Comprehensive Cancer Center
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	17
Start date	30 December 2014
Primary completion	17 July 2017
Estimated completion	1 October 2018
Sites	1 location across United States

Drugs / interventions tested

• Aspirin — full drug profile →
• Simvastatin (simvastatin) — full drug profile →
• Observation

Conditions studied

• Solid Tumor — all drugs for Solid Tumor →
• Cancer — all drugs for Cancer →

Sponsor

Case Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Solid Tumor or Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Inflammation and tumor progression: signaling pathways and targeted intervention.
   Zhao H, Wu L, Yan G, Chen Y, et al · · 2021 · cited 1932× · PMID 34248142 · DOI 10.1038/s41392-021-00658-5
2. Risk of Arterial Thromboembolism in Patients With Cancer.
   Navi BB, Reiner AS, Kamel H, Iadecola C, et al · · 2017 · cited 475× · PMID 28818202 · DOI 10.1016/j.jacc.2017.06.047
3. Cancer-associated pathways and biomarkers of venous thrombosis.
   Hisada Y, Mackman N. · · 2017 · cited 289× · PMID 28807983 · DOI 10.1182/blood-2017-03-743211
4. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy.
   Di Nisio M, Porreca E, Candeloro M, De Tursi M, et al · · 2016 · cited 68× · PMID 27906452 · DOI 10.1002/14651858.cd008500.pub4
5. Managing thrombosis in cancer patients.
   Wang TF, Li A, Garcia D. · · 2018 · cited 35× · PMID 30046747 · DOI 10.1002/rth2.12102
6. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy.
   Rutjes AW, Porreca E, Candeloro M, Valeriani E, et al · · 2020 · cited 29× · PMID 33337539 · DOI 10.1002/14651858.cd008500.pub5
7. Posttranslational control of lipogenesis in the tumor microenvironment.
   Zhu Y, Lin X, Zhou X, Prochownik EV, et al · · 2022 · cited 27× · PMID 36038892 · DOI 10.1186/s13045-022-01340-1
8. Thromboembolism in Patients with Bladder Cancer: Incidence, Risk Factors and Prevention.
   Zareba P, Duivenvoorden WCM, Pinthus JH. · · 2018 · cited 14× · PMID 29732385 · DOI 10.3233/blc-170146