Non-Functional Pituitary Adenoma, Pituitary Tumor, Nonfunctioning
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, efficacy, PK, and PD of the chimeric dopamine-somatostatin receptor agonist, TBR-760, in adult patients with NFPA over 52 weeks.
Detailed description
This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, efficacy, PK, and PD of the chimeric dopamine-somatostatin receptor agonist, TBR-760, in adult patients with NFPA over 52 weeks. Approximately 150 patients will be enrolled.
Interventions
DRUGTBR-760
TBR-760 is intended for SC administration. The target dose to be studied in this study is 6 mg SC given once weekly.
DRUGPlacebo
Placebo
Sponsors
Tiburio Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double blind placebo controlled
Intervention model description
Double blind placebo controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Confirmed diagnosis of NFPA (defined as lack of clinical and biochemical evidence of adenohypophyseal hormone excess), and be status-post one TSS with a NFPA remnant of ≥ 10mm (maximum diameter) * Study subjects must be capable of giving informed consent and reading and signing the informed consent form after the nature of the study has been fully explained by the Investigator or Investigator designee * Study subject must be willing and able to complete all study assessments and procedures and to communicate effectively with the Investigator and site staff. Key
Exclusion criteria
* Has undergone more than one TSS, or had TSS \<6 months prior to screening, or is anticipated to require TSS within 6 months of Screening * Has undergone radiation therapy to the head for any reason, or is already planned to have or anticipated to require radiation therapy during the study period; * Has any contraindications to magnetic resonance imaging including allergy or intolerance to gadolinium or gadolinium-based contrast; * In the opinion of the Investigator, the patient is unable to meet the requirements of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tumor volume reduction | 52 weeks | the primary efficacy endpoint is the percentage of patients with tumor volume reduction |
Outcome results
None listed