"A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-Tumour Activity of Adavosertib (AZD1775) in Japanese Patients with Advanced Solid Tumours"

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225236

Enrollment

Registered

2020-06-18

Start date

2020-06-24

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 Tumours

Interventions

investigational material(s) Generic name etc : Adavosertib (AZD1775) INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: "Japanese patients 20 years or more of age at the time of study entry Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0,1 Adequate bone marrow reserve or organ function Female patients who are not of child-bearing potential, and fertile females of childbearing potential who agree to use adequate contraceptive measures Male patients should be willing to use barrier contraception Predicted life expectancy 12 weeks or more Histologically or cytologically documented locally advanced or metastatic solid tumour, excluding lymphoma, for which standard therapy does not exist or has proven ineffective or intolerable Measurable or non-measurable disease according to RECIST v1.1"

Exclusion criteria

Exclusion criteria: "Use of anti-cancer treatment drug during the past 21 days or 5 half-lives (whichever is shorter) prior to the first dose of adavosertib Use of an investigational drug during the past 30 days or 5 half-lives (whichever is longer) prior to the first dose of the study treatment Common Terminology Criteria for Adverse Events (CTCAE) Grade >1 toxicity from prior therapy Inability to swallow oral medication or any other condition that may impact adavosertib intake/absorption Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases Any of the cardiac diseases currently or within the last 6 months Any underlying medical condition that would impair the patient's ability to receive study treatment Other invasive malignancy within 5 years prior to the first dose of study drug except for non-invasive malignancies"

Design outcomes

Primary

Measure	Time frame
safety -	—

Secondary

Measure	Time frame
efficacy pharmacokinetics -	—

Countries

Japan

Outcome results

None listed

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