A Phase 1, Open-Label, Dose Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of AMG 386 in Adult Japanese Patients with Advanced Solid Tumors
- Conditions
- Advanced solid tumor
- Registration Number
- JPRN-jRCT2080221126
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 18
Major inclusion criteria include the following:
1)Men or women, 20 to 74 years old
2)Histologically or cytologically documented and definitively diagnosed, advanced solid tumor that is refractory to standard treatment or for which no curative therapy is available
3)Eastern Cooperative Oncology Group (ECOG) of 0 or 1
Major exclusion criteria include the following:
1)Primary central nervous system (CNS) tumors, including any CNS lymphoma
2)History of CNS metastases
3)Hematological malignancies
4)Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to CTCAE grade 0 or 1, or to levels specified in the inclusion/exclusion criteria with the exception of alopecia
5)Clinically significant cardiovascular disease within 1 year prior to enrollment, including myocardial infarction, unstable angina, New York Heart Association class 2 or greater heart failure, peripheral vascular disease, cerebrovascular accident, transient ischemic attack, or arrhythmias not controlled by outpatient medication
6)Uncontrolled hypertension [diastolic > 90 mmHg; systolic >150 mmHg].
7)History of arterial or venous (deep vein) thrombosis within 1 year before enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method