ATRiUM
Research type
Research Study
Full title
ATRiUM: A phase 1 trial to assess the safety, tolerability, pharmacokinetics and preliminary antitumor activity of ascending doses of combined therapy with ATR inhibitor AZD6738 and gemcitabine, Using a Model based design.
IRAS ID
236448
Contact name
Bristi Basu
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Eudract number
2017-003935-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
This trial is being carried out to explore the safety, tolerability and anti-tumour activity of a combination of gemcitabine and a new anti-cancer drug called AZD6738 in patients with solid tumours. Gemcitabine is anti-cancer drug which is routinely used as a treatment for various types of cancers.
There are 2 parts to this trial. All participants will receive both study drugs.
Part 1 is a dose escalation phase. During this phase AZD6738 will be given in combination with gemcitabine. Doses will be increased as participants are recruited. Within part 1 there are 2 treatment schedules, continuous and intermittent. Participants will be allocated to either the continuous administration schedule (AZD6738 once daily for 21 days and gemcitabine administered on days 3, 10 and 17 of every 28 days cycle) or the intermittent administration schedule (AZD6738 once daily on days 1 to 4, 8 to 11 and 15 to 18, and gemcitabine administered on days 3, 10 and 17 of every 28 days cycle).
Part 2 is a dose expansion phase and will only recruit patients with inoperable, locally advanced or metastatic pancreatic cancer. The schedule(s) and dose levels determined from Part 1 will be allocated to all participants.
Up to 55 evaluable participants will be recruited across approximately 4 participating sites. Up to forty (40) participants will be registered in to the dose escalation phase of the trial, followed by up to fifteen (15) participants in the treatment expansion phase. Participants will undergo routine and research tests and assessments. Participation is expected to last a maximum of 1 year, plus a 28 day screening period. Participants that have withdrawn or completed the study will be referred back to their usual hospital doctor.
REC name
East of England - Essex Research Ethics Committee
REC reference
19/EE/0128
Date of REC Opinion
13 Jun 2019
REC opinion
Further Information Favourable Opinion