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

Phase 1

Suspended

• Conditions: Advanced Solid Tumours

• Registration Number: JPRN-jRCT2080225236
• Lead Sponsor: AstraZeneca KK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: suspended
• Sex: All
• Target Recruitment: 12

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>-

Secondary Outcome Measures

Name	Time	Method
efficacy<br>pharmacokinetics<br>-