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

• ClinicalTrials.gov Identifier: NCT04335357
• Recruitment Status: Not yet recruiting
• First Posted: April 6, 2020
• Last Update Posted: April 6, 2020
• Sponsor: Tiburio Therapeutics
• Information provided by (Responsible Party): Tiburio Therapeutics

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-Functional Pituitary Adenoma; Pituitary Tumor, Nonfunctioning	Drug: TBR-760; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double blind placebo controlled
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Double blind placebo controlled
• Primary Purpose: Treatment
• Official Title: A One Year, Randomized, Double-Blind, Placebo-Controlled Study of TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas
• Estimated Study Start Date: May 2020
• Estimated Primary Completion Date: March 2023
• Estimated Study Completion Date: June 2023

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: placebo; The appearance and fill of placebo syringes will be identical to the active comparator.	Drug: Placebo; Placebo
Active Comparator: TBR-760; TBR-760 is supplied as a ready-to-use solution in pre-filled syringes at a concentration of 5 mg/ml.	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.

Outcome Measures

Primary Outcome Measures :

1. tumor volume reduction [ Time Frame: 52 weeks ]
   the primary efficacy endpoint is the percentage of patients with tumor volume reduction

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Tiburio Therapeutics
• ClinicalTrials.gov Identifier: NCT04335357
• Other Study ID Numbers: TBR-760-NFPA-201
• First Posted: April 6, 2020
• Last Update Posted: April 6, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Adenoma; Pituitary Neoplasms; Pituitary Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms