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A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE (ASTER)

Abelacimab versus apixaban in the treatment of cancer associated VTE (ASTER)

Hara Yochiro

IQVIA Services Japan G.K.

4-10-18 Takanawa, Minato-ku, Tokyo 108-0074

yoichiro.hara@iqvia.com

jRCT Inquiry Receipt Center

IQVIA Services Japan G.K.

4-10-18 Takanawa, Minato-ku, Tokyo 108-0074

+81-3-6859-9500

yoichiro.hara@iqvia.com

Not Recruiting

Sept. 01, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

prevention purpose

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.

- 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)

Both

Cancer associatated thrombosis

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.

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).

+81-59-232-1111

April. 19, 2023

No

USA/Canada/Australia/Korea/Taiwan/China/Austria/Czechia/France/Germany/Hungary/Ireland/Italy/Latvia/Netherlands/Norway/Spain/Sweden/Switzerland