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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

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

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221126
Enrollment
18
Registered
2010-06-10
Start date
2010-06-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced solid tumor

Interventions

Sponsors

Takeda Pharmaceutical Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026