AZD6738 in combination with other agents in Solid Malignancies

• Research type

  Research Study

• Full title

  A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD6738 in combination with Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients with Advanced Solid Malignancies

• IRAS ID

  160200

• Contact name

  Kate Beaujeaux

• Contact email

  beaujeuxk@medimmune.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2014-002233-66

• Duration of Study in the UK

  2 years, 1 months, 19 days

• Research summary

  Information submitted previously:
  AZD6738 is a new anti-cancer treatment being developed. It has not yet been approved for use by the regulatory authorities and therefore this study is part of a research project. This study is being carried out to investigate the safety and tolerability of AZD6738, taken in combination with other anti-cancer agents, in patients with advanced cancer for whom no standard treatment options are available.

  There are two parts in this study:
  • Part A is to find the highest dose of AZD6738, which does not result in too many unacceptable side effects, in combination with other anti-cancer agents in patients with any type of cancer
  • Part B is to collect further information on the combination of AZD6738 and other anti-cancer agents in patients who have a particular type of advanced cancer. In module 1, looking at combination of AZD6738 with carboplatin, two specific groups of patients will be enrolled:
  1. Non-small cell lung adenocarcinoma (NSCLC) with tumours that have low expression of ATM (Ataxia Telangiectasia Mutated) enzyme
  2. Platinum resistant high grade serous ovarian cancer

  When patients have finished taking part in this study, their Study Doctor will decide how to continue to manage their condition.

  New information added 26Feb2024, to support ARSAC application for Module 5 only.
  Module 5 of D5330C00004 is a Phase I, open-label, multicentre study to assess the safety, tolerability,
  pharmacokinetics and pharmacodynamics of ceralasertib in combination with AZD5305 to determine the maximum tolerated dose or recommended phase 2 dose of the combination, in participants with advanced/metastatic ovarian cancer.

  There are 2 parts to this combination module of this study:
  - Part A, dose escalation of ceralasertib in combination with AZD5305; and
  - Part B, dose expansion of ceralasertib in combination with AZD5305.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  14/NW/1238

• Date of REC Opinion

  15 Sep 2014

• REC opinion

  Favourable Opinion