TAS3681 in Metastatic Castration Resistant Prostrate Cancer
Research type
Research Study
Full title
A Phase 1, Open-Label, Non-Randomized, Safety, Tolerability, and Pharmacokinetic Study of TAS3681 in Patients with Metastatic Castration Resistant Prostate Cancer
IRAS ID
191408
Contact name
Johann De Bono
Contact email
Sponsor organisation
Taiho Oncology, Inc.
Eudract number
2015-002745-55
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
127092, IND number
Duration of Study in the UK
3 years, months, days
Research summary
TAS3681 is a new study medication developed for the treatment of advanced castration-resistant prostate cancer, for which no standard therapy exists.
There are two parts to this study: dose escalation and expansion. Participants only take part in one or the other part of the study, depending on which part is open at the time participation.
The purpose of the dose escalation part of this study is to determine the safety, tolerability, activity and preliminary anti-cancer activity of TAS3681 and to find the appropriate dose and dosing schedule of TAS3681 to be used in the expansion part of the study. The purpose of expansion part of the study is to determine the safety, efficacy and activity of TAS3681 at the dose and dosing regimen chosen at the end of dose escalation, and examine what genetic characteristics might be able to predict a response to the study medication.
The dose of study medication that participants will be given depends upon when they enter the clinical study. The medication they receive will be given to them in cycles. During each cycle, they will take their study medication for 28 days. Regardless of the phase of the study that they participate in, they will continue to receive TAS3681 for as long as their doctor believes they are receiving a benefit from the medication, or until they choose to discontinue their participation in this study.
Each participant attends 4 study visits plus 4 study visits in cycle 1 and 3 study visits for each subsequent cycle. They undergo a number of tests at each visit including blood tests, physical examinations and CT scans.
Approximately 130 patients from the US and EU are expected to take part in this study.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
15/LO/2028
Date of REC Opinion
8 Feb 2016
REC opinion
Further Information Favourable Opinion