Apixaban for the treatment of venous thromboembolism in patients with cancer

Phase 1

• Conditions: Venous thromboembolism in cancer patients; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003093-40-DE
• Lead Sponsor: Fondazione FADOI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-09
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1) Consecutive patients with a newly diagnosed, objectively confirmed:
• Symptomatic or unsuspected, proximal lower-limb DVT or
• Symptomatic PE or
• Unsuspected PE in a segmental or more proximal pulmonary artery.
2) Any type of cancer (other than basal-cell or squamous-cell carcinoma
of the skin, primary brain tumor or known intracerebral metastases and
acute leukemia) that meets at least one of the following:
• Active cancer defined as diagnosis of cancer within six months before
the study inclusion, or receiving treatment for cancer at the time of
inclusion or any treatment for cancer during 6 months prior to
randomization, or recurrent locally advanced or metastatic cancer.
• Cancer diagnosed within 2 years before the study inclusion (history of
cancer).
3) Signed and dated informed consent, available before the start of any
specific trial procedure.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 818
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

Exclusion Criteria

1) Age <18 years
2) ECOG Performance Status III or IV;
3) Life expectancy of less than 6 months;
Related to anticoagulant treatment:
4) Administration of therapeutic doses of LMWH, fondaparinux, or
unfractionated heparin (UFH) for more than 72 hours before
randomization;
5) 3 or more doses of a vitamin K antagonist before randomization;
6) Thrombectomy, vena cava filter insertion, or thrombolysis used to
manage the index episode;
7) Iindication for anticoagulant treatment for a disease other than the
index VTE episode;
8) Concomitant use of strong inhibitors or inducers of both cytochrome
P-450 3A4 and P-Glycoprotein (see Appendix 1);
Related to bleeding risk:
9) Concomitant thienopyridine therapy (clopidogrel, prasugrel, or
ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy;
10) Active bleeding or high risk of bleeding contraindicating
anticoagulant treatment
11) Recent (in the last 1 month prior to randomization) brain, spinal
or ophthalmic surgery
12) Hemoglobin level lower than 8 g/dL (5.0 mmol/L) or platelet count
<75x109/L or history of heparin-induced thrombocytopenia;
13) Creatinine clearance < 30 ml /min based on the Cockcroft Gault
equation;
14) Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine
aminotransferase level 3 times or more and/or bilirubin level 2 times or
more higher the upper limit of the normal range;
15) Uncontrolled hypertension (systolic BP> 180 mm Hg or diastolic BP
> 100 mm Hg despite antihypertensive treatment);
Standard criteria:
16) Bacterial endocarditis;
17) Hypersensitivity to the study drugs or to any of their excipients;
18) Patients participation in other pharmaco therapeutic program with
an experimental therapy that is known to effect the coagulation system.
19) Women of childbearing potential (WOCBP) who do not practice a
medically accepted highly effective contraception during the trial and
one month beyond. Highly effective contraception methods are:
a. combined (estrogen and progestogen containing) hormonal
contraception associated with inhibition of ovulation
b. progestogen-only hormonal contraception associated with inhibition
of ovulation
c. intrauterine device (IUD)
d. intrauterine hormone-releasing system (IUS)
e. bilateral tubal occlusion
f. vasectomized partner
g. sexual abstinence ;
20) Pregnancy, or breast feeding
21) Any condition that, as judged by the investigator, would place the
subject at increased risk of harm if he/she participated in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified