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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04335357
Other study ID # TBR-760-NFPA-201
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date May 2020
Est. completion date June 2023

Study information

Verified date April 2020
Source Tiburio Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date June 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Intervention

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.
Placebo
Placebo

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tiburio Therapeutics

Outcome

Type Measure Description Time frame Safety issue
Primary tumor volume reduction the primary efficacy endpoint is the percentage of patients with tumor volume reduction 52 weeks
See also
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