Study of Adavosertib(AZD1775) in Japanese Patients With Advanced Solid Tumours

• Status: Active, not recruiting
• Trial end date: 2021-07-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics(PK) and anti-tumour activity of adavosertib in Japanese patients with advanced solid tumours. This study consists of 2 cohorts, Cohort1 and Cohort2. At least 3, or up to 6, evaluable Japanese patients with advanced solid tumours will be enrolled in each cohort to confirm the tolerability.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Adavosertib; MK-1775

Criteria

Major Inclusion Criteria:

• Japanese patients ≥20 years 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

• 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

Major Exclusion Criteria:

• Use of anti-cancer treatment drug ≤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