NCT02450175

Brief Summary

The purpose of this research study is to understand if platelets in the blood become more active during cancer and specially advanced stages of cancer, in the future the investigators want to see if reducing platelet activity can improve survival in advanced cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

May 18, 2015

Last Update Submit

May 20, 2015

Conditions

Neoplasm

Keywords

Platelet Activationmetastasis

Outcome Measures

Primary Outcomes (1)

  • Platelet reactivity

    1 day

Secondary Outcomes (1)

  • Release of vasoactive substances, e.g. TGF Beta,

    1 day

Study Arms (2)

Cases

NO INTERVENTION

Patients with cancer whose platelets are examined

Control

PLACEBO COMPARATOR

Patients without cancer whose platelets are examined for comparison

Drug: EverolimusDrug: Letrozole

Interventions

EverolimusDRUG

10 mg of Everolimus daily (by mouth)

Control
LetrozoleDRUG

2.5mg taken daily (by mouth)

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cases:
  • Controls:
  • patients will be selected based on age (+/- 5 years), sex and ethnicity matches from the outpatient medicine Clinic at Sinai hospital, as well as the Sinai community care clinic.

You may not qualify if:

  • Thrombocytopenia, defined as a platelet count of \<100,000 at the time of
  • recruitment of in the last available laboratory data
  • History of known bleeding disorder or known platelet dysfunction
  • Patients on antiplatelet treatment or anticoagulant therapies at the time of enrollment or 10 days prior to testing
  • CKD stage IV or greater

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SInai Hospital of Baltimore, Inc.

Baltimore, Maryland, 21215, United States

RECRUITING

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Interventions

EverolimusLetrozole

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsNitrilesTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Oncologist

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 21, 2015

Study Start

June 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations

US(1)