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

Phase 1

• Conditions: Advanced solid tumor

• Registration Number: JPRN-jRCT2080221129
• Lead Sponsor: Takeda Pharmaceutical Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 18

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

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 <= 5 x ULN will be acceptable if the subject has liver metastases.
7)Uncontrolled diabetes, defined as having hemoglobin A1c (HbA1c) >= 6.5% and fasting blood glucose level >= 130 mg/d

Study & Design

• Study Type: Interventional
• Study Design: Not specified