Clinical Trials List
Protocol NumberANT-008
NCT Number(ClinicalTrials.gov Identfier)NCT05171075
2022-04-01 - 2027-03-26
Phase III
Recruiting1
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)
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/11/17
Investigators and Locations
Principal Investigator
Tsai-Yun Chen
Co-Principal Investigator
- 楊舜如 Division of Hematology & Oncology
- Ya-Ting Hsu Division of Hematology & Oncology
- Chia-Jui Yen Division of Hematology & Oncology
- 顏志傑 Division of Hematology & Oncology
- Yu-Min Yeh Division of Hematology & Oncology
- Ya-Ping Chen Division of Hematology & Oncology
- Chun-Hui Lee Division of Hematology & Oncology
- Hui-Jen Tsai Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Venous Thromboembolism
Objectives
In patients with GI or GU cancer who have recently been diagnosed with VTE, the efficacy of abelacimab in preventing VTE recurrence was evaluated up to 6 months after randomization.
Test Drug
abelacimab
Active Ingredient
abelacimab
Dosage Form
Concentrate for solution for injection
Dosage
150
Endpoints
o Assess whether abelacimab is superior to dalteparin in preventing major or CRNM-related bleeding up to 6 months after randomization.
o Assess whether abelacimab is superior to dalteparin in net clinical benefit (defined as survival without VTE recurrence or major or CRNM-related bleeding events) up to 6 months after randomization.
o Assess whether abelacimab is superior to dalteparin in preventing VTE recurrence up to 6 months after randomization.
o Assess whether abelacimab is superior to dalteparin in the proportion of patients who permanently discontinue treatment not due to death up to 6 months after randomization.
o Assess whether abelacimab is superior to dalteparin in preventing CRNM-related bleeding events up to 6 months after randomization.
o Assess whether abelacimab is superior to dalteparin in preventing major bleeding events up to 6 months after randomization.
o Assess whether abelacimab is superior to dalteparin in preventing major bleeding events up to 6 months after randomization. Up to 6 months after randomization, is abelacimab superior to dalteparin in preventing major GI and CRNM-related bleeding?
The safety and tolerability of abelacimab relative to dalteparin were evaluated up to 6 months after randomization, and the incidence of injection site reactions, allergic reactions, and immunogenicity was assessed in patients treated with abelacimab.
o Assess whether abelacimab is superior to dalteparin in net clinical benefit (defined as survival without VTE recurrence or major or CRNM-related bleeding events) up to 6 months after randomization.
o Assess whether abelacimab is superior to dalteparin in preventing VTE recurrence up to 6 months after randomization.
o Assess whether abelacimab is superior to dalteparin in the proportion of patients who permanently discontinue treatment not due to death up to 6 months after randomization.
o Assess whether abelacimab is superior to dalteparin in preventing CRNM-related bleeding events up to 6 months after randomization.
o Assess whether abelacimab is superior to dalteparin in preventing major bleeding events up to 6 months after randomization.
o Assess whether abelacimab is superior to dalteparin in preventing major bleeding events up to 6 months after randomization. Up to 6 months after randomization, is abelacimab superior to dalteparin in preventing major GI and CRNM-related bleeding?
The safety and tolerability of abelacimab relative to dalteparin were evaluated up to 6 months after randomization, and the incidence of injection site reactions, allergic reactions, and immunogenicity was assessed in patients treated with abelacimab.
Inclution 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 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
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
Exclusion Criteria
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 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 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 or spinal procedures such as lumbar puncture or epidural/spinal anesthesia within 4 weeks of 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 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 of <3 months at randomization
Calculated creatinine clearance (CrCl) <30 mL/min 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 ≥3 times and/or bilirubin ≥2 times the upper limit of normal (ULN) at the screening visit 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.
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 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 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 or spinal procedures such as lumbar puncture or epidural/spinal anesthesia within 4 weeks of 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 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 of <3 months at randomization
Calculated creatinine clearance (CrCl) <30 mL/min 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 ≥3 times and/or bilirubin ≥2 times the upper limit of normal (ULN) at the screening visit 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.
The Estimated Number of Participants
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Taiwan
38 participants
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Global
1020 participants
