D6014C00007, Phase I, Open-label, Continued Access to AZD1775
Research type
Research Study
Full title
An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of AZD1775 for Patients Enrolled in AZD1775 Clinical Pharmacology Studies
IRAS ID
228751
Contact name
Jeff Evans
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2016-001910-94
Duration of Study in the UK
2 years, 3 months, 31 days
Research summary
This is an open-label, non-randomised study to provide continued access (CA) to AZD1775 for eligible patients with advanced solid tumours who have previously completed an AZD1775 clinical study. The study will investigate the safety of a once daily monotherapy regimen of AZD1775 in patients with advanced solid tumours.
All patients who completed 1 of the parent clinical studies are eligible for this study after the specified washout period defined in the parent study protocol and meet the eligibility criteria specified in this protocol.
During the study, patients will continue to receive AZD1775 as long as they are benefiting from treatment in the Investigator’s opinion and do not meet any other discontinuation criteria.
Enrolment in the CA study will continue until all eligible patients in the parent clinical studies have done 1 of the following; enrolled in the CA study, discontinued from the parent study, or declined to participate in the CA study.
The study consists of a Screening Period (lasting a minimum of 4 days, up to a maximum of 14 days), a Treatment Period (each cycle lasting 21 days, cycles will be completed until patient no longer benefiting, withdraws or meets any other discontinuation criteria), an End of Treatment (EoT) visit (within 7 days after stopping treatment) and 30-Day Safety Follow-up period (to assess any Adverse Events).
This study will be conducted at approximately 25 study centres across the European Union and United States. The number of patients who enrol is dependent on the number of patients who complete 1 of the parent clinical studies, who tolerate AZD1775 in the parent study, who meet the eligibility criteria for this continued access study and are willing to participate in this continued access (CA) study.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0256
Date of REC Opinion
12 Sep 2017
REC opinion
Further Information Favourable Opinion