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Cancer Venous Thromboembolism (VTE)

Primary Purpose

Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Edoxaban
Dalteparin
Low molecular weight heparin
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thromboembolism (VTE) focused on measuring Active Cancer with Metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Edoxaban group

Dalteparin group

Arm Description

After 5 days of low molecular weight heparin (LMWH), patients receive edoxaban treatment daily - tablet for oral use

Participants receive Dalteparin treatment daily -solution for subcutaneous injection

Outcomes

Primary Outcome Measures

Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event

Secondary Outcome Measures

Number of Participants With Adjudicated Major Bleeding Events While on Treatment
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).
Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period
Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period
Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period
Number of Participants With VTE-Related Death
Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death

Full Information

First Posted
February 25, 2014
Last Updated
February 8, 2019
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02073682
Brief Title
Cancer Venous Thromboembolism (VTE)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 16, 2015 (Actual)
Primary Completion Date
September 15, 2017 (Actual)
Study Completion Date
September 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Cancer
Keywords
Active Cancer with Metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1046 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Edoxaban group
Arm Type
Experimental
Arm Description
After 5 days of low molecular weight heparin (LMWH), patients receive edoxaban treatment daily - tablet for oral use
Arm Title
Dalteparin group
Arm Type
Active Comparator
Arm Description
Participants receive Dalteparin treatment daily -solution for subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Other Intervention Name(s)
DU-176b
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dalteparin
Other Intervention Name(s)
Active comparator
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Low molecular weight heparin
Other Intervention Name(s)
LMWH
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Participants With Adjudicated Major Bleeding Events While on Treatment
Description
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).
Time Frame
12 months
Title
Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period
Time Frame
12 months
Title
Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period
Time Frame
12 months
Title
Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period
Time Frame
12 months
Title
Number of Participants With VTE-Related Death
Time Frame
12 months
Title
Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
City
Brandon
State/Province
Florida
Country
United States
City
Jonesboro
State/Province
Georgia
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Leuven
State/Province
Vlaams-Brabant
Country
Belgium
City
Saint-Etienne cedex 2
Country
France
City
Debrecen
State/Province
Hajdu-Bihar Megye
Country
Hungary
City
Varese
Country
Italy
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
29231094
Citation
Raskob GE, van Es N, Verhamme P, Carrier M, Di Nisio M, Garcia D, Grosso MA, Kakkar AK, Kovacs MJ, Mercuri MF, Meyer G, Segers A, Shi M, Wang TF, Yeo E, Zhang G, Zwicker JI, Weitz JI, Buller HR; Hokusai VTE Cancer Investigators. Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism. N Engl J Med. 2018 Feb 15;378(7):615-624. doi: 10.1056/NEJMoa1711948. Epub 2017 Dec 12.
Results Reference
derived
PubMed Identifier
26271200
Citation
van Es N, Di Nisio M, Bleker SM, Segers A, Mercuri MF, Schwocho L, Kakkar A, Weitz JI, Beyer-Westendorf J, Boda Z, Carrier M, Chlumsky J, Decousus H, Garcia D, Gibbs H, Kamphuisen PW, Monreal M, Ockelford P, Pabinger I, Verhamme P, Grosso MA, Buller HR, Raskob GE. Edoxaban for treatment of venous thromboembolism in patients with cancer. Rationale and design of the Hokusai VTE-cancer study. Thromb Haemost. 2015 Nov 25;114(6):1268-76. doi: 10.1160/TH15-06-0452. Epub 2015 Aug 13.
Results Reference
derived

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Cancer Venous Thromboembolism (VTE)

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