Open-label, dose escalation Phase 1/2a study (liver related cancers)
Research type
Research Study
Full title
A Phase 1/2a Study in 3 Parts (Phase 1a and Phase 1b - Dose Escalations and Phase 2a Expansion Cohorts) to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of MIV-818 in Patients with Liver Cancer Manifestations
IRAS ID
245556
Contact name
Elizabeth Plummer
Contact email
Sponsor organisation
Medivir AB
Eudract number
2018-000995-14
Duration of Study in the UK
3 years, 6 months, 0 days
Research summary
The purpose of this study is to evaluate the safety of the experimental drug MIV-818 and to investigate the response in the patients’ tumour after receiving MIV-818. The investigational product, MIV-818, is an orally administered drug, aimed as a treatment for liver related cancers.
This study is divided into three parts that are referred to as “phases”. These phases are described below:
1) Both Phase 1a and Phase 1b of the study will be conducted to understand the side effects of the drug is. Patients will have either advanced liver cancer or a different type of cancer which has spread
to the liver. The patient may get more than one dose level the study drug in phase 1a to determine a suitable dose for further evaluation in later parts of the study. The dose levels of study drug given to
patients in successive groups will increase when lower doses are considered well tolerated in phase 1b.a) A Safety Review Committee (SRC) will review all safety data for each patient, prior to the next patient being enrolled in phase 1a.
b) The SRC will review all safety data for all patients in a group, prior to the next group being treated at a higher dose level in phase 1b. If more than 2 patients’ in a group of 6 patients has predefined safety
concerns at a given dose level, no higher doses will be explored, and that dose level will be considered suitable for further investigation.2) Phase 2a will be conducted once phases 1a and 1b have been completed. The purpose of the phase 2a is to test the safety and effectiveness of the drug is and to evaluate the patients with specific
advanced liver cancers only.REC name
West of Scotland REC 1
REC reference
18/WS/0121
Date of REC Opinion
1 Aug 2018
REC opinion
Further Information Favourable Opinion