TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas

Non-Functional Pituitary Adenoma Clinical Trial

Official title:

A One Year, Randomized, Double-Blind, Placebo-Controlled Study of TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04335357
• Other study ID #: TBR-760-NFPA-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2020
• Est. completion date: June 2023

Study information

• Verified date: April 2020
• Source: Tiburio Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Non-Functional Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor, Nonfunctioning

Intervention

Drug:
• TBR-760
TBR-760 is intended for SC administration. The target dose to be studied in this study is 6 mg SC given once weekly.
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tiburio Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor volume reduction	the primary efficacy endpoint is the percentage of patients with tumor volume reduction	52 weeks