Status:
UNKNOWN
TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas
Lead Sponsor:
Tiburio Therapeutics
Conditions:
Non-Functional Pituitary Adenoma
Pituitary Tumor, Nonfunctioning
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04335357
Start Date
May 1 2020
End Date
June 1 2023
Last Update
April 6 2020
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