Abelacimab versus dalteparin in the treatment of GI/GU cancer and associated VTE

Phase 1

• Conditions: venous thromboembolism (VTE) in patients with gastrointestinal/genitourinary cancer; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-003085-12-ES
• Lead Sponsor: Anthos Therapeutics, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-24
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1020

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 acute 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 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
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 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 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 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 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 <3 months at randomization
• Calculated creatinine clearance (CrCl) <30 mL/min (Cockcroft-Gault equation)
• Platelet count <50,000/mm3
• Hemoglobin <8 g/dL
• Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase (ALT) =3 x and/or bilirubin =2 x upper limit of normal (ULN) 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified