Back to resultsTBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas
Primary Purpose
Non-Functional Pituitary Adenoma, Pituitary Tumor, Nonfunctioning
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TBR-760
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-Functional Pituitary Adenoma
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
TBR-760
Arm Description
The appearance and fill of placebo syringes will be identical to the active comparator.
TBR-760 is supplied as a ready-to-use solution in pre-filled syringes at a concentration of 5 mg/ml.
Outcomes
Primary Outcome Measures
tumor volume reduction
the primary efficacy endpoint is the percentage of patients with tumor volume reduction
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04335357
Brief Title
TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas
Official Title
A One Year, Randomized, Double-Blind, Placebo-Controlled Study of TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2020 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tiburio Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Functional Pituitary Adenoma, Pituitary Tumor, Nonfunctioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double blind placebo controlled
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double blind placebo controlled
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
The appearance and fill of placebo syringes will be identical to the active comparator.
Arm Title
TBR-760
Arm Type
Active Comparator
Arm Description
TBR-760 is supplied as a ready-to-use solution in pre-filled syringes at a concentration of 5 mg/ml.
Intervention Type
Drug
Intervention Name(s)
TBR-760
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
tumor volume reduction
Description
the primary efficacy endpoint is the percentage of patients with tumor volume reduction
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas
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