JPRN-jRCT2080221126UnknownPhase 1
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
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 18
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to <= 74age old (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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