EUCTR2021-003085-12-NOActive, not recruitingPhase 1
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 - MAGNOLIA
Anthos Therapeutics0 sites1,020 target enrollmentStarted: February 10, 2022Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,020
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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 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 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
- •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 510
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 510
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 120 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 or spinal procedures such as lumbar puncture or epidural/spinal anesthesia 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 brain, spinal cord, cardiac, vascular, major thoracic and/or major abdominal surgery in the 4 weeks following randomization
- •History of heparin-induced thrombocytopenia
- •Infective acute or subacute endocarditis at the time of presentation
- •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) at the screening visit
- •Platelet count <50,000/mm3 at the screening visit
- •Hemoglobin <8 g/dL at the screening visit
- •Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase (ALT) =3 x and/or bilirubin =2 x upper limit of normal (ULN) at the screening visit 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.
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