A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anthos Therapeutics, Inc.
• Collaborators: IQVIA Biotech; Itreas
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

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:

• 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 acute 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 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) occurrence of 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 for VTE treatment prior to randomization (e.g., atrial fibrillation, mechanical heart valve, prior VTE)

• PE leading to hemodynamic instability (systolic BP <90 mmHg or shock).

• Acute ischemic or hemorrhagic stroke or intracranial hemorrhage, in the last 4 weeks preceding screening.

• Brain trauma, or cerebral or a spinal cord surgery in the 4 weeks preceding screening

• Need for aspirin in a dosage of more than 100 mg/day or, any other antiplatelet agent alone or in combination with aspirin

• Bleeding requiring medical attention at the time of randomization or in 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 of <3 months at randomization

• Calculated creatinine clearance (CrCl) <30 mL/min

• Platelet count <50,000/ mm3

• Hemoglobin <8 g/dL

• Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase ≥3 times and/or bilirubin ≥2 times the upper limit of normal in the absence of clinical explanation

• Uncontrolled hypertension (systolic blood pressure [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

• 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 judgement of the Investigator 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 pharmacodynamic effect has returned to baseline, whichever is longer. Participation in academic non-interventional studies or interventional studies, comprising testing different strategies or different combinations of registered drugs is permitted.