An open-label phase I study of AS-0141 in patients with advanced, metastatic, relapsed or refractory malignancies

JRCT ID: jRCT2031210072

Registered date:07/05/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Solid tumors and hematologic malignancies (AML, MDS, DLBCL)
• Date of first enrollment: 11/06/2021
• Target sample size: 75
• Study type: Interventional
• Intervention(s): AS-0141 will be orally administered twice a day (5 days on/2 days off, or everyday) in a 21-day treatment cycle. The starting dose will be 40 mg/day.

Outcome(s)

• Primary Outcome: Dose limiting toxicity

Key inclusion & exclusion criteria

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

Include criteria

- Aged >18 years at time of informed consent
- Histlogically confirmed solid tumors, AML, MDS, or DLBCL for which no standard therapy is available
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) <= 1 (solid tumors and DLBCL) or <= 2 (AML and MDS)
- Life expectancy at least 3 months (90days)

Exclude criteria

- Patient with known high microsatellite instability(MSH-H)
- Any of the following complicating desease
1) Uncontrolled diabetes
2) Interstitial pneumonia, pulumonary fibrosis, radiation pneumonia (including history)
3) Active infection disease requiring systemic treatment such as antimicrobial agent, antivirus agent
4) AML patients with leukocytosis over 30,000/mm^3 in peripheral leukocyte count
- Any of following serious cardiac or cardiovascular condition
1) Congestive heart failure
2) Class III/ IV heart failure according to the New York Heart Association [NYHA] criteria
3) Ischemic myocardial disease (angina pectoris which needs treatment or revascularization, miocardinal infarction, unstable and symptomatic ischemic heart disease, etc) within 6 months before study drug administration
4) Uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, or ventricular tachycardia)
5) Uncontrolled hypertension
6) Ischemic cerebrovascular accident (history of transient ischemic attack, arterial blood circulation reconstruction, etc.)

Related Information

• Primary Sponsor: Arimura Akinori