TBR-760 in patients with NFPA
Research type
Research Study
Full title
A One Year, Randomized, Double-Blind, Placebo-Controlled Study of TBR-760 in Adult Patients with Non-Functioning Pituitary Adenomas
IRAS ID
271821
Contact name
Niki Karavitaki
Contact email
Sponsor organisation
Tiburio Therapeutics, Inc.
Eudract number
2019-003142-32
Duration of Study in the UK
1 years, 11 months, 12 days
Research summary
This multinational study will be conducted at about 30 study sites and in 150 adult patients with non-functioning pituitary adenomas (NFPA), over a period of 52 weeks, excluding a screening period of 6 weeks.
This is the first study of TBR-760 in adult patients with NFPAs.Eligible patients will have a remnant NFPA status post transsphenoidal surgery (TSS), meaning not all of the benign adenoma tissue could be removed during surgery. These enrolled patients will be randomised to receive either TBR-760 (the investigational drug) or placebo, with a 50% chance to receive either. Patients randomized to receive TBR-760 will receive subcutaneous (SC) dosing
on Day 1 (1 mg), Day , Day 8 (2mg), Day 15 (4mg), Day 22 (6mg) and thereafter at weekly intervals.
Patients randomised to placebo will receive placebo at the same dosing intervals as for the study drug, with pre-filled syringe fill volumes identical to those receiving TBR-760.
The first 4 doses of study drug or placebo, will be administered under the supervision of the site during on-site visits, when patients will be trained in
self-administration of the study drug which will be provided in pre-filled syringes.Safety will be assessed via vital signs, laboratory tests (from blood collected at certain time points in the study), targeted physical examinations and collection of adverse events (AEs).
Efficacy will be assessed with pituitary magnetic resonance imaging (MRI) to measure tumour remnant size (volume and diameter).
PK and PD measures will be performed at selected site visits. Comprehensive PK blood sampling will take place on approximately 40 patients.
Quality of Life questionnaires will be completed to assess the potential effects of the study drug.
Concomitant medications will be monitored throughout the study.
A Data Safety Monitoring Board (DSMB) will meet at regular intervals to monitor the overall safety of the patients in the study.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0055
Date of REC Opinion
19 Mar 2020
REC opinion
Further Information Favourable Opinion