Open-label continued access study for adavosertib clinical pharmacology studies

• 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 Adavosertib for Patients With Advanced Solid Tumours Enrolled in Adavosertib Clinical Pharmacology Studies

• IRAS ID

  1003550

• Contact name

  Teresa Tian

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2020-005413-41

• Research summary

  Continued access study for participants enrolled in adavosertib clinical pharmacology studies
  AstraZeneca is sponsoring this open-label study, for adult patients with Advanced Solid Tumours who have taken part in other adavosertib clinical pharmacology studies (parent studies). The study drug is called adavosertib. The purpose of this study is to allow continued adavosertib treatment of patients with advanced solid tumours participating in the parent studies, and to assess the continued safety and tolerability of adavosertib for patients who continue the therapy. Based on clinical studies, adavosertib is expected to have anti-cancer activity in particular tumour types, however there is no certainty that participants will benefit from this study drug. The study will be conducted in the UK, Spain and USA and be open to patients who have completed a parent study. Approximately 70 participants are expected to take part. Participants will be in the study for as long as the participant and study doctor believe the participant is benefitting from adavosertib treatment. The study consists of the following periods:
  • Screening – determine whether patients meet the criteria to take part in the study.
  • Treatment – starts from first dose of adavosertib (given orally) and continues until the disease worsens, the participant decides to stop receiving adavosertib or leaves the study, or the study doctor decides it necessary for the participant to stop treatment.
  • End of Treatment Visit – occurs if participant stops taking adavosertib before disease worsens.
  • Follow-up – occurs after participant has stopped taking adavosertib.
  Participants will undergo procedures including, but not limited to signing an Informed Consent Form, providing medical history, physical examinations, and providing blood and urine samples. Participants can continue to receive adavosertib after the study ends if, in the opinion of the study doctor, they are continuing to receive clinical benefit.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  21/LO/0244

• Date of REC Opinion

  18 Jun 2021

• REC opinion

  Further Information Favourable Opinion