Oral Apixaban (Eliquis) Versus Enoxaparin (Lovenox) for Thromboprophylaxis in Women With Suspected Pelvic Malignancy

Apixaban (Eliquis) is an oral anticoagulant for the treatment and prevention of
thromboembolic events. It is advantageous as there is no need to perform routine blood
monitoring tests including, international normalized ratio (INR), partial thromboplastin time
(PTT) and Factor Xa, to determine clotting in participants receiving treatment. Several
studies have shown the efficacy of apixaban for the treatment and prevention of VTE.

We anticipate that the same efficacy could be replicated in the prevention of VTE in women
undergoing surgery for gynecologic cancer. An oral-anticoagulant for standard treatment for
prevention of VTE outcomes following surgery could help improve the surgical mortalities
associated with gynecologic oncology surgical patients, improve patient adherence for
outpatient treatment, and reduce VTE surveillance and outcomes.

Inclusion Criteria:

- Suitable candidate for surgery (meets appropriate performance status, no significant
cardiac/renal/hepatic dysfunction

- Diagnosis of pelvic malignancy (suspected/confirmed ovarian, endometrial/uterine,
cervical cancers, and vulvar cancers) undergoing surgical debulking,

- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to
surgery,

- Women must not be breastfeeding, WOCBP must agree to follow instructions for method(s)
of contraception for the duration of treatment with study drug(s) apixaban plus 5
half-lives of study drug apixaban (2.5 days) plus 30 days (duration of ovulatory
cycle) for a total of 32.5 days post-treatment completion.

Exclusion Criteria:

- Malignancy or mass that is non-gynecologic in origin (mass/tumor of origin other than
reproductive organ such as rectal, abdominal, breast)

- Positive pregnancy test on day of surgery,

- Known history of Venous (Thromboembolism) VTE prior to diagnosis (DVT or Pulmonary
Embolism (PE)) due to increased underlying risk of new event

- Concomitant NSAIDS or other anticoagulant/antiplatelet therapy including
Acetylsalicylic Acid (Aspirin) (ASA) >81mg/day,

- SSRIs and SNRIs (common anti-depressant therapies),

- Uncontrolled severe hypertension (systolic >200 mmHg or diastolic >120 mmHg),

- With prosthetic heart valves,

- Active bleeding condition (not limited to: thrombocytopenia, haemophilias, potential
bleeding lesions, recent trauma or surgery, recent stroke, confirmed intracranial or
intraspinal bleeding),

- Known or documented bleeding disorders not limited to: anti-phospholipid syndrome,
homozygotes for Factor V Leiden deficiency, antithrombin III deficiency, protein C
deficiency, Protein S deficiency, hyperhomocysteinemia, systemic lupus erythematous,
or Prothrombin G2020 gene mutation,

- Significant renal disease as defined by creatinine clearance less than 30 mL/min,

- Significant liver disease as defined as Aspartate Transaminase (AST) or Alanine
Transaminase (ALT) twice than normal,

- Concomitant use of dual strong inhibitors or inducers (CYP3A4, P-gp)

- Protein C deficiency (increased risk of skin necrosis do those on injectable
anticoagulation),

- Documented allergy to apixaban and/or enoxaparin,

- Patient's deemed otherwise clinically unfit for clinical trial per Investigator's
discretion