A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
18 Years and older, Male and Female
ANT-008 (primary)
NCI-2022-08854
2021-003085-12
Summary
This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of
abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in
patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia)
Objectives
Cancer associated thrombosis (CAT) is a severe medical condition which is characterized by
high incidence of Venous thromboembolism (VTE) recurrence and high risk for bleeding.
Patients with intact GI and GU cancer have increased bleeding risk with oral direct
anticoagulants (DOACs), Guidelines advice caution with those DOACs or state preference for
low molecular weight heparin (LMWH) in this population. The ANT-008 study will compare
treatment with abelacimab monthly administration to LMWH daily subcutaneous (sc)
administration over 6-month treatment. The study outcomes include VTE recurrence, bleeding
event and treatment discontinuation at 6 months
Eligibility
- 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:
- Unresectable, locally advanced, metastatic, or non-metastatic GI/GU cancer and
- No intended curative surgery during the study
- Confirmed symptomatic or incidental proximal lower limb deep vein thrombosis (DVT) (i.e., popliteal, femoral, iliac, and/or inferior vena cava vein thrombosis) and/or a confirmed symptomatic pulmonary embolism (PE), or an incidental PE in a segmental, or larger pulmonary artery. Patients are eligible within 120 hours from diagnosis of the qualifying VTE.
- Anticoagulation therapy with LMWH for at least 6 months is indicated
- Able to provide written informed consent
Treatment Sites in Georgia
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