Cancer Venous Thromboembolism (VTE)

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073682
• Other study ID #: DU176b-D-U311
• Secondary ID: 2014-004708-30
• Status: Completed
• Phase: Phase 3
• Start date: July 16, 2015
• Est. completion date: September 15, 2017

Study information

• Verified date: September 2018
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1046
• Est. completion date: September 15, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  France,  Hungary,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event		12 months
Secondary	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).	12 months
Secondary	Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period		12 months
Secondary	Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period		12 months
Secondary	Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period		12 months
Secondary	Number of Participants With VTE-Related Death		12 months
Secondary	Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death		12 months