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Solid TumorEarly Phase 1NCT02285738

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

A Early Phase 1 study testing Aspirin, Simvastatin and Observation in people with Solid Tumor and Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Cancer
What is being tested?
Aspirin, Simvastatin and Observation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
30 Dec 2014to 1 Oct 2018
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic diagnosis of malignancy of a solid organ or lymphoma
  • Planned to initiate a new systemic chemotherapy regimen (including patients starting on first chemotherapy or patients previously treated but starting on a new regimen)
  • VTE Risk Score ≥1
  • Written, informed consent.

Who cannot join

  • Hematologic malignancies including acute and chronic leukemias, myelodysplastic syndromes, lymphoma and myeloma
  • Primary brain tumors
  • Active bleeding or high risk of bleeding in the opinion of the investigator
  • Hepatic dysfunction (elevated transaminases or bilirubin > 3 times normal)
  • Planned stem cell transplant
  • Life expectancy < 6 months
Show all 10Show fewer
  • Acute or chronic renal insufficiency with creatinine clearance < 30 mL/min
  • Pregnancy
  • Known allergy to or prior intolerance of aspirin and/or simvastatin.
  • Ongoing anticoagulant, statin and/or anti-platelet therapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis: A Pilot Study

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.

Read the detailed description

Objectives

Primary: To determine efficacy of aspirin with and without simvastatin in solid tumor patients at high- or intermediate-risk for VTE, in reducing markers of platelet activation, levels of inflammatory and angiogenic cytokines measured using high-throughput approaches, and clinical and investigational measures of hemostatic activation.

Secondary: To determine safety and feasibility of aspirin with or without simvastatin in solid tumor patients at high- or intermediate-risk for VTE

Conditions
Solid Tumor, Cancer
Being tested
Aspirin, Simvastatin, Observation
Keywords
solid tumor, cancer, simvastatin, aspirin, blood clot, VTE, venous thromboembolism
Medical subject headings
Neoplasms, Thrombosis, Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AspirinDrug

    81mg/day for 4 weeks

  • SimvastatinDrug

    Daily dose of Simvastatin for 4 weeks

  • ObservationOther

    participants will be observed for thrombotic evens for 4 weeks

Study groups in NCT02285738
Study groupRoleWhat they receive
Aspirin+Asprin/Simvastatin+Observation (ASO)Active comparatorAspirin 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
Receives: Drug: Aspirin; Drug: Simvastatin; Other: Observation
Aspirin+Observation+Asprin/Simvastatin (AOS)ExperimentalAspirin 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
Receives: Drug: Aspirin; Drug: Simvastatin; Other: Observation
Aspirin/Simvastatin+Observation+Asprin (SOA)ExperimentalAspirin 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
Receives: Drug: Aspirin; Drug: Simvastatin; Other: Observation
Aspirin/Simvastatin+Asprin+Observation (SAO)ExperimentalAspirin 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.
Receives: Drug: Aspirin; Drug: Simvastatin; Other: Observation
Observation+Aspirin/Simvastatin+Asprin (OSA)ExperimentalObservation 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.
Receives: Drug: Aspirin; Drug: Simvastatin; Other: Observation
Observation+Aspirin+Asprin/Simvastatin (OAS)ExperimentalObservation 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.
Receives: Drug: Aspirin; Drug: Simvastatin; Other: Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in average sP-selectin levels

    Change in sP-selectin levels as indicator of measure efficacy

    Measured: at 16 weeks of treatment

Secondary outcomes (13)

  1. Frequency of major bleeding complications or clinically significant non-bleeding complications per patient

    The safety endpoint will be bleeding complications over 17 weeks (16 weeks of study plus an additional week of observation). This will include major bleeding events and clinically significant non-major bleeding events. A bleeding event will be defined as major if it satisfies one or more of the following: decrease in hemoglobin of 2 g/dL or more, leads to transfusion of two or more units of blood or packed cells, occurs in a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial) or leads to death. Clinically significant, non-major bleeding will be defined as bleeding that does not meet the criteria for major bleeding, and has at least one of the following characteristics: multiple-source bleeding; spontaneous hematoma >25 cm2; epistaxis >5 min; macroscopic hematuria not related to instrumentation; spontaneous rectal bleeding; gingival bleeding > 5 min; hemoptysis; hematemesis; or prolonged bleeding (> 5 min) after venipuncture.

    Measured: at 17 weeks after beginning treatment

  2. Change in average Platelet Factor 4

    measure of efficacy using plasma level of platelet activation markers

    Measured: at 16 weeks of treatment

  3. Change in average CD40 ligand

    measure of efficacy using plasma level of platelet activation markers

    Measured: at 16 weeks of treatment

  4. Change in average serum thromboxane B2

    measure of efficacy using plasma level of platelet activation markers

    Measured: at 16 weeks of treatment

  5. Change in average serum VEGF

    measure of efficacy using plasma level of angiogenesis markers

    Measured: at 16 weeks of treatment

  6. Change in average serum angiopoietin-2

    measure of efficacy using plasma level of angiogenesis markers

    Measured: at 16 weeks of treatment

  7. Change in average serum hepatocyte growth factor

    measure of efficacy using plasma level of angiogenesis markers

    Measured: at 16 weeks of treatment

  8. Change in average serum PECAM

    measure of efficacy using plasma level of angiogenesis markers

    Measured: at 16 weeks of treatment

  9. Change in average serum PDGF

    measure of efficacy using plasma level of angiogenesis markers

    Measured: at 16 weeks of treatment

  10. Change in average plasma F1.2

    measure of efficacy using plasma level of hemostatic activation markers

    Measured: at 16 weeks of treatment

  11. Change in average plasma TAT complexes

    measure of efficacy using plasma level of hemostatic activation markers

    Measured: at 16 weeks of treatment

  12. Change in average plasma D-dimer

    measure of efficacy using plasma level of hemostatic activation markers

    Measured: at 16 weeks of treatment

  13. Change in the number of thrombotic events

    the number of thrombotic events measured by the number of events related to venus thrombosis, pulmonary embolism, visceral vein thrombosis as well as arterial thromboembolic events including stroke, myocardial infarction or arterial embolism

    Measured: 17 weeks after beginning treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2014 (estimated)
  2. Study start30 Dec 2014
  3. Primary completion17 Jul 2017
  4. Study completion1 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02285738
Sponsor's protocol ID
CASE8Y14
Status last verified
May 2019
First submitted
5 Nov 2014
Last updated
8 May 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Aspirin, Simvastatin and Observation in people with Solid Tumor and Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in average sP-selectin levels (time frame: at 16 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02285738.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.

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