Cancer Venous Thromboembolism (VTE)

February 8, 2019 updated by: Daiichi Sankyo, Inc.

A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer

The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH) compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will be compared with dalteparin for superiority.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1046

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium
  • France
      • Saint-Etienne cedex 2, France
  • Hungary
    • Hajdu-Bihar Megye
      • Debrecen, Hajdu-Bihar Megye, Hungary
  • Italy
      • Varese, Italy
  • Netherlands
      • Amsterdam, Netherlands
  • United States
    • Florida
      • Brandon, Florida, United States
    • Georgia
      • Jonesboro, Georgia, United States
    • Michigan
      • Detroit, Michigan, United States
    • Virginia
      • Norfolk, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects with age ≥ 18 years or the otherwise legal lower age according to the country of residence;
  • Confirmed acute lower extremity proximal DVT or PE for which long term treatment with low molecular weight heparin (LMWH) is indicated;
  • Cancer, other than basal-cell or squamous-cell carcinoma of the skin;
  • Able to provide written informed consent.

Exclusion Criteria:

  • Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) episode of DVT and/or PE;
  • Treatment with therapeutic doses of an anticoagulant other than that used for pretreatment of the current (index) VTE episode prior to randomization;
  • Active bleeding or high risk for bleeding contraindicating treatment with LMWH or edoxaban;
  • Any other contraindication listed in the local labeling of dalteparin, enoxaparin, or edoxaban;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Edoxaban group
After 5 days of low molecular weight heparin (LMWH), patients receive edoxaban treatment daily - tablet for oral use
Drug: Edoxaban
After the 5 day treatment with LMWH, patients receive edoxaban 60 mg once daily (QD) as 2 × 30 mg tablets (or 1 x 30 mg tablet QD for patients requiring dose adjustment) for the remainder of the treatment period.
Other Names:
  • DU-176b
Drug: Low molecular weight heparin
Therapeutic doses of subcutaneous LMWH were administered for at least 5 days (to patients in the edoxaban group); this 5-day period may have included the pre-randomization LMWH (if applicable). The choice of parenteral LMWH was up to the treating physician.
Other Names:
  • LMWH
Active Comparator: Dalteparin group
Participants receive Dalteparin treatment daily -solution for subcutaneous injection
Drug: Dalteparin
Dalteparin was administered via subcutaneous injection at a dose of 200 IU/kg (maximum daily dose 18,000 IU) for 30 days, and at a dose of 150 IU/kg from Day 31 to the end of treatment.
Other Names:
  • Active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adjudicated Major Bleeding Events While on Treatment
Time Frame: 12 months
The primary safety endpoint was major bleeding events during the On-Treatment Study Period (defined as on-study drug or up to 3 days after the last dose of study drug).
12 months
Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period
Time Frame: 12 months
12 months
Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period
Time Frame: 12 months
12 months
Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period
Time Frame: 12 months
12 months
Number of Participants With VTE-Related Death
Time Frame: 12 months
12 months
Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2015

Primary Completion (Actual)

September 15, 2017

Study Completion (Actual)

September 15, 2017

Study Registration Dates

First Submitted

February 25, 2014

First Submitted That Met QC Criteria

February 25, 2014

First Posted (Estimate)

February 27, 2014

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

February 8, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DU176b-D-U311
  • 2014-004708-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD Sharing Time Frame

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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