Trial | NCT04335357  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    TBR-760 ...

  • Study Participants

    150
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.
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.
Study Started
May 31
2020
Anticipated
Primary Completion
Mar 31
2023
Anticipated
Study Completion
Jun 30
2023
Anticipated
Last Update
Apr 06
2020

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.

Drug Placebo

Placebo

placebo Placebo Comparator

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

TBR-760 Active Comparator

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

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.
No Results Posted