A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

• Male or female subjects >=18 years old or other legal maturity age according
to the country of residence
• Confirmed GI (colorectal, pancreatic, gastric, esophageal, gastro-esophageal
junction or hepatobiliary) or confirmed GU (renal, ureteral, bladder, prostate,
or urethra) cancers if:
o Unresectable, locally advanced, metastatic, or non-metastatic GI/GU cancer and
o No intended curative surgery during the study
• Confirmed symptomatic or incidental proximal lower limb acute DVT (i.e.,
popliteal, femoral, iliac, and/or inferior vena cava vein thrombosis) and/or a
confirmed symptomatic PE, or an incidental PE in a segmental, or larger
pulmonary artery. Patients are eligible within 72 hours from diagnosis of the
qualifying VTE.
• Anticoagulation therapy with LMWH for at least 6 months is indicated.
• 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) DVT and/or PE
• More than 72 hours of pre-treatment with therapeutic doses of UFH, LMWH, or
other anticoagulants
• An indication to continue treatment with therapeutic doses of an
anticoagulant other than that for VTE treatment prior to randomization (e.g.,
AF, mechanical heart valve, prior VTE)
• PE leading to hemodynamic instability (blood pressure [BP] <90 mmHg or
shock)
• Acute ischemic or hemorrhagic stroke or intracranial hemorrhage within 4
weeks of screening
• Brain trauma or a cerebral or spinal cord surgery within 4 weeks of screening
• Need for aspirin in a dosage of >100 mg/day or any other antiplatelet
agent alone or in combination with aspirin
• Bleeding requiring medical attention at the time of randomization or within
the preceding 4 weeks
• Planned major surgery at baseline
• History of heparin-induced thrombocytopenia
• Primary brain cancer or untreated intracranial metastasis
• Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 at
screening
• Life expectancy <3 months at randomization
• Calculated creatinine clearance (CrCl) <30 mL/min (Cockcroft-Gault
equation)
• Platelet count <50,000/mm3
• Hemoglobin <8 g/dL
• Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine
aminotransferase (ALT) >=3 x and/or bilirubin >=2 x upper limit of normal (ULN)
in absence of clinical explanation
• Uncontrolled hypertension (systolic BP >180 mm Hg or diastolic BP >100
mm Hg) despite antihypertensive treatment
• Women of child-bearing potential (WOCBP) who are unwilling or unable to use
highly effective contraceptive measures during the study from screening up to 3
days after last treatment of dalteparin or 100 days after administration of
abelacimab (See Section 5.3.6 for highly effective contraceptive measures)
• Sexually active males with sexual partners of childbearing potential must
agree to use a condom or other reliable contraceptive measure up to 3 days
after last treatment of dalteparin or 100 days after administration of
abelacimab.
• Pregnant or breast-feeding women
• History of hypersensitivity to any of the study drugs (including dalteparin)
or its excipients, to drugs of similar chemical classes, or any
contraindication listed in the label for dalteparin
• Subjects with any condition that in the Investigator*s judgement would place
the subject at increased risk of harm if he/she participated in the study
• Use of other investigational (not-registered) drugs within 5 half-lives prior
to enrollment or until the expected PD effect has returned to baseline,
whichever is longer. Participation in academic non-interventional studies or
interventional studies testing different strategies or different combinations
of registered drugs is permitted.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to assess whether abelacimab is<br /><br>non-inferior to dalteparin for preventing VTE recurrence through 6 months<br /><br>post randomization in patients with GI or GU cancer and recently diagnosed VTE.<br /><br>If non-inferiority is demonstrated, then superiority will be<br /><br>assessed.</p><br>

Secondary Outcome Measures