Study of AZD4573 in Relapsed or Refractory Haematological Malignancies
Research type
Research Study
Full title
A Phase 1, Open-Label, Multicentre, Non-Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of AZD4573, a Potent and Selective CDK9 Inhibitor, in Subjects with Relapsed or Refractory Haematological Malignancies
IRAS ID
230053
Contact name
Andrew Davies
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2017-000817-22
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is a multicentre, open-label, phase 1, first-in-human, dose escalation research study on participants with blood cell related cancers that have has either stayed the same or worsened during or after the last treatment (known as relapsed or refractory) and no further standard of care exists for their current condition. There is currently a high unmet need for treatment in this population.
The purpose of this study sponsored by AstraZeneca AB is to assess the safety and tolerability of the study medicine AZD4573. Samples will be collected to understand how well AZD4573 is taken up by the body (Pharmacokinetics) and to understand the effect of AZD4573 on biological readouts (Pharmacodynamics).Approximately 42 participants will take part. The total length of participation including the ramp up cycles is up to about 10 months. This includes 30 days screening period and 30-day post treatment safety follow-up visit.
The study involves four ramp up cycles during which the dose of AZD4573 (given into the vein) will be slowly increased every 2 weeks. After reaching the final dose, if no side effects are experienced, they will continue in the study for up to six months. The study has at least five treatment groups. Each group will receive different doses of AZD4573.
After each dose level during the dose escalation phase, a safety review committee will evaluate the safety/tolerability and Pharmacodynamics of AZD4573 to decide whether to progress to the next dose.
To closely monitor how the body responds to AZD4573, participants will be admitted to the hospital for occasional overnight stays.
Study procedures include: Physical examination, heart check (12-lead ECG), ECHO/MUGA (heart function test), blood and urine tests, review of medications and how the participant is feeling, tests to assess the status of the Myeloma, skeletal survey, bone marrow biopsy & aspirate, CT/MRI/PET scans.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0317
Date of REC Opinion
12 Sep 2017
REC opinion
Further Information Favourable Opinion