Abelacimab versus apixaban in the treatment of cancer associated VTE

JRCT ID: jRCT2041230073

Registered date:29/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cancer associatated thrombosis
• Date of first enrollment: 11/01/2024
• Target sample size: 66
• Countries of recruitment: USA,Japan,Canada,Japan,Australia,Japan,Korea,Japan,Taiwan,Japan,China,Japan,Austria,Japan,Czechia,Japan,France,Japan,Germany,Japan,Hungary,Japan,Ireland,Japan,Italy,Japan,Latvia,Japan,Netherlands,Japan,Norway,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan
• Study type: Interventional
• Intervention(s): Patients who consent to study participation should undergo a screening/run-in period of up to 120 hours to confirm eligibility criteria. A SoC treatment for VTE (e.g., recommended dose of a direct oral anticoagulant [DOAC], unfractionated heparin [UFH], LMWH or fondaparinux) should be administered during the screening/run-in period. Patients who continue to meet all inclusion and exclusion criteria will be randomized to abelacimab or apixaban in a 1:1 ratio. Patients will be stratified by study region, cancer location (GI/GU vs. other), and symptomatic vs incidental VTE. Patients assigned to abelacimab will receive abelacimab 150 mg iv on Day 1, followed by once monthly 150 mg sc dosing approximately 30 days (+- 5 days) after the iv dose for 5 additional months (6 total treatments). Patients assigned to apixaban will directly start 10 mg of po apixaban twice-daily (bid) for 7 days following randomization, then 5 mg po bid for a total treatment duration of 6 months. The above-mentioned events occurring up to the end of study visit will be adjudicated in all randomized patients. Patients who complete 6 months of treatment will enter a follow-up period of up to 70 days.

Outcome(s)

Primary Outcome

Recurrent VTE is either:
- Confirmed new symptomatic or incidental proximal DVT of the legs, iliac veins and/or inferior vena cava
- Confirmed new symptomatic PE
- Confirmed new incidental PE located in segmental or more proximal arteries.
- Fatal PE (including unexplained death for which PE cannot be ruled out).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Adult male or female subjects are eligible for study participation if they have confirmed (histology, adequate imaging modality) diagnosis of cancer (other than basal-cell or squamous cell carcinoma of the skin) and presentation with acute VTE, for which long-term treatment with DOACs is indicated. The key eligibility criteria include (all the following must be met at the screening and randomization visits):
- Male or female subjects >= 18 years old or another legal maturity age according to the country of residence
- Confirmed diagnosis of cancer (by histology or adequate imaging modality), other than basal-cell or squamous-cell carcinoma of the skin alone with one of the following:
- Active cancer, defined as either locally active, regionally invasive, or metastatic cancer at the time of randomization, and/or
- Currently receiving or having received anticancer therapy(radiotherapy, chemotherapy, hormonal therapy, any kind of targeted therapy or any other anticancer therapy) in the last 6 months.
- 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.

Exclude 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, fondaparinux, DOAC, or other anticoagulants
- An indication to continue treatment with therapeutic doses of an anticoagulant other than that used for VTE treatment prior to randomization (e.g., atrial fibrillation, mechanical heart valve, prior VTE)
- Platelet count <50,000/mm3 at the screening visit
- PE leading to hemodynamic instability (systolic blood pressure [BP] <90 mmHg or shock)
- Acute ischemic or hemorrhagic stroke or intracranial hemorrhage within 4 weeks preceding screening
- Brain trauma, or a cerebral or a spinal cord surgery or spinal procedures such as lumbar puncture or epidural/spinal anesthesia in the 4 weeks preceding screening
- Need for aspirin in a dosage of more than 100 mg/per day or any other antiplatelet agent alone or in combination with aspirin
- Primary brain cancer or untreated intracranial metastases
- Acute myeloid or lymphoid leukemia
- 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
- 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 at the screening visit
- Hemoglobin less than 8 g/dL at the screening visit
- Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range 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)

Related Information

• Primary Sponsor: Hara Yochiro
• Secondary ID(s): NCT05171049