venous thromboembolism (VTE) in patients with gastrointestinal/genitourinary cancer
Conditions
Sponsors
Anthos Therapeutics
Eligibility
Sex/Gender
All
Inclusion 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: 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
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] 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 6 months post randomization;Main Objective: The primary objective of this study is to assess whether abelacimab is non-inferior to dalteparin for preventing VTE recurrence through 6 months post randomization in patients with GI or GU cancer and recently diagnosed VTE. If non-inferiority is demonstrated, then superiority will be assessed.;Secondary Objective: 1. To assess whether abelacimab is superior to dalteparin for preventing occurrence of the composite of major or CRNM bleeding 2. To assess whether abelacimab is superior to dalteparin on net clinical benefit defined as survival without VTE recurrence, or major or CRNM bleeding events 3. To assess whether abelacimab is superior to dalteparin on the rate of permanent treatment discontinuation not due to death 4. To assess whether abelacimab is superior to dalteparin for preventing occurrence of CRNM bleeding events 5. To assess whether abelacimab is superior to dalteparin for preventing occurrence of major bleeding events 6. To assess whether abelacimab is superior to dalteparin for preventing occurrence of the composite of GI major and CRNM bleeding 7. To evaluate safety and tolerability of abelacimab relative to dalteparin and to assess the incidence rate of injection site reactions, hypersensitivity reactions and immunogenicity in patients treated with abelacimab ;Primary end point(s): Time to first event of centrally adjudicated VTE recurrence | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to first event of ISTH-adjudicated major or CRNM bleeding events 2. Time to first event of VTE recurrence, ISTH-adjudicated major or ISTH-adjudicated CRNM bleeding events 3. Time to event of permanent treatment discontinuation not due to death 4. Time to first event of ISTH-adjudicated CRNM bleeding events 5. Time to first event of ISTH-adjudicated major bleeding events 6. Time to first event of GI ISTH-adjudicated major and GI CRNM bleeding events 7. All-cause death, vascular death, serious adverse events, adverse events leading to drug discontinuation, other adverse events, abnormal lab tests, etc. presented as rate per 100 patient-years • For patients treated with abelacimab: o Percentage of patients with injection site reactions o Percentage of patients with injection site reactions by severity status o Percentage of patients with hypersensitivity reactions o Percentage of patients with hypersensitivity reactions by severity status o Percentage of patients with ADA formation o Percentage of patients with persistent ADA formation o Percentage of patients with neutralizing antibody (NAb) formation. ;Timepoint(s) of evaluation of this end point: 6 months post randomization | — |
Countries
Australia, Austria, Canada, China, Czechia, France, Germany, Hungary, Ireland, Italy, Korea, Republic of, Latvia, Netherlands, Norway, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactInformation Desk
Anthos Therapeutics
Outcome results
None listed