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TBR-760 in Non-Functioning Pituitary Adenomas
NCT04335357Phase 2
Key facts
- Status
- Unknown
- Start
- May 2020
- Primary completion
- Mar 2023
- Sponsor
- Tiburio Therapeutics
- Modality
- Peptides, Small Molecules
- Drugs
- onzigolide
- Conditions
- non-functioning pituitary adenoma (NFPA)
01
Overview
Phase 2, randomised, double-blind trial in non-functioning pituitary adenoma (NFPA) comparing Placebo Arm with TBR-760 Arm (2 arms). Primary endpoint: Tumor Volume Reduction at 52 weeks. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo Arm
Placebo administered SC once weekly
TBR-760 Arm
TBR-760 6 mg administered SC once weekly
03
Who it enrols
Adult patients with confirmed non-functioning pituitary adenoma (NFPA) who have undergone one transsphenoidal surgery (TSS) with a remnant tumor ≥ 10mm. Patients must not have had more than one TSS, TSS < 6 months prior, or any prior radiation therapy.
04
Endpoints
Primary
Tumor Volume Reduction
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