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

NCT ID: NCT04335357

Last Updated: 2020-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-31
• Study Completion Date: 2023-06-30

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.

Conditions

Non-Functional Pituitary Adenoma; Pituitary Tumor, Nonfunctioning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

placebo

The appearance and fill of placebo syringes will be identical to the active comparator.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

TBR-760

TBR-760 is supplied as a ready-to-use solution in pre-filled syringes at a concentration of 5 mg/ml.

Group Type: ACTIVE_COMPARATOR

TBR-760

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tiburio Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TBR-760-NFPA-201

Identifier Type: -

Identifier Source: org_study_id