Save

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

PHASE3RECRUITING

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).

Simpliy with AI

Study details:

Cancer associated thrombosis (CAT) is a severe medical condition which is characterized by high incidence of Venous thromboembolism (VTE) recurrence and high risk for bleeding. Patients with intact GI and GU cancer have increased bleeding risk with oral direct anticoagulants (DOACs), Guidelines advice caution with those DOACs or state preference for low molecular weight heparin (LMWH) in this population. The ANT-008 study will compare treatment with abelacimab monthly administration to LMWH daily subcutaneous (sc) administration over 6-month treatment.

The study outcomes include VTE recurrence, bleeding event and treatment discontinuation at 6 months.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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.

Simplify with AI

Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-09-27

Primary completion: 2026-12-01

Study completion finish: 2027-02-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05171075

Intervention or treatment

BIOLOGICAL: Abelacimab

DRUG: Dalteparin

Conditions

• Venous Thromboembolism
• Deep Venous Thrombosis
• Pulmonary Embolism

Condition: Venous Thromboembolism, Deep Venous Thrombosis and more
BIOLOGICAL: Abelacimab and other drugs
Blacktown, New South Wales, Australia and more
Sponsor: Anthos Therapeutics, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Blacktown Hospital

Research sites nearby

Select from list below to view details:

Blacktown Hospital
Blacktown, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Northern Health
Epping, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Abelacimab Abelacimab intravenous administration followed by monthly administration of the same dose subcutaneously	BIOLOGICAL: Abelacimab Abelacimab 150 mg
ACTIVE_COMPARATOR: Dalteparin Dalteparin administered subcutaneously daily	DRUG: Dalteparin Dalteparin 200 IU/kg/day followed by 150 IU/kg/day

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Time to first event of centrally adjudicated VTE recurrence consisting of new proximal deep venous thrombosis, new pulmonary embolism (PE) or fatal PE, including unexplained death for which PE cannot be ruled out	Not Specified	6 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Time to first event of ISTH-adjudicated major or clinically relevant non-major (CRNM) bleeding events	Not Specified	6 months
Net clinical benefit defined as survival without VTE recurrence, or major or CRNM bleeding	Not Specified	6 months

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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