A Phase 1, Open-Label, Dose Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of AMG 479 in Adult Japanese Patients with Advanced Solid Tumors

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221129

Enrollment

Registered

2010-06-11

Start date

2010-06-11

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

investigational material(s) Generic name etc : AMG 479 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Major inclusion criteria include the following: 1)Histologically or cytologically documented and definitively diagnosed, advanced solid tumor that is refractory to standard treatment or for which no curative therapy is available 2)Eastern Cooperative Oncology Group (ECOG) performance status : 0 or 1 3)20 to 74 years old at the time of obtaining the informed consent

Exclusion criteria

Exclusion criteria: Major exclusion criteria include the following: 1)Hematological malignancies 2)Primary central nervous system (CNS) tumors, including primary CNS lymphoma 3)Presence of untreated CNS metastases 4)Presence of symptomatic CNS metastases 5)Unresolved Common Terminology Criteria for Adverse Events (CTCAE) hematologic toxicities >= grade 2 from prior anti-cancer therapy. Lymphopenia >= 500/microL and hemoglobin >= 9.0 g/dL will be acceptable. 6)Unresolved CTCAE non-hematological toxicities >= grade 2 from prior anti-cancer therapy, excluding alopecia. AST or ALT = 6.5% and fasting blood glucose level >= 130 mg/dL

Outcome results

None listed

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