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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-Functional Pituitary Adenoma, Pituitary Tumor, Nonfunctioning

Intervention / Treatment
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* Drug: TBR-760
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind placebo controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>The appearance and fill of placebo syringes will be identical to the active comparator. | Drug: Placebo<br>* Placebo<br>|
| Active Comparator: TBR-760<br>TBR-760 is supplied as a ready-to-use solution in pre-filled syringes at a concentration of 5 mg/ml. | Drug: TBR-760<br>* TBR-760 is intended for SC administration. The target dose to be studied in this study is 6 mg SC given once weekly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor volume reduction | the primary efficacy endpoint is the percentage of patients with tumor volume reduction | 52 weeks |