NCT04949425

A Study to Assess the Safety and Tolerability of Adavosertib for Patients With Advanced Solid Tumours

An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of Adavosertib for Patients With Advanced Solid Tumours Enrolled in Adavosertib Clinical Pharmacology Studies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to allow continued adavosertib treatment of patients with advanced solid tumours participating in the adavosertib clinical pharmacology studies and to assess the continued safety and tolerability of adavosertib for patients enrolled in adavosertib clinical pharmacology studies (hereafter referred to as the 'parent studies') who continue to use the therapy

Detailed description

Patients will be screened within 14 days of Day 1 of the treatment period. During screening, patients will undergo an appropriate washout period after the last dose of adavosertib in the parent clinical pharmacology study before receiving the first dose of adavosertib in this study. Patients will continue to receive adavosertib as long as they are benefiting from treatment in the investigator's opinion and do not meet any other discontinuation criteria. The number of patients who enroll is dependent on the number of patients who complete the parent studies, and who tolerate adavosertib in the parent study. The anticipated total duration of the study is approximately 3 years.

Conditions

• Advanced Solid Tumours

Interventions

Type	Name	Description
DRUG	Adavosertib	Patients will receive Adavosertib orally.

Timeline

• Start date: 2021-09-13
• Primary completion: 2022-04-21
• Completion: 2022-04-21
• First posted: 2021-07-02
• Last updated: 2022-09-02

Locations

2 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study