Non-Functioning Pituitary Adenomas MedDRA version: 21.1 Level: LLT Classification code 10035079 Term: Pituitary adenoma System Organ Class: 100000004864
Conditions
Interventions
Product Code: TBR-760
Pharmaceutical Form: Solution for injection
CAS Number: 778630-77-6
Current Sponsor code: TBR-760
Other descriptive name: TBR-760 triacetate
Concentration unit: mg/ml milligram(s
Sponsors
Tiburio Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, =18 or =80 years of age; 2. Confirmed diagnosis of NFPA (defined as lack of clinical and biochemical evidence of adenohypophyseal hormone excess), and be status-post one TSS; 3. At the time of Screening, must have NFPA remnant following TSS of =10mm (maximum diameter) based on locally read MRI performed =24 months ago; 4. Female patients must not be pregnant and be highly unlikely to become pregnant. Male patients must be unlikely to impregnate a partner. Male or female patients must meet at least one of the following criteria: c. A female patient who is not of reproductive potential is eligible without requiring the use of contraception. A female patient who is not of reproductive potential is defined as one who: (1) has reached natural menopause (defined as 12 months of spontaneous amenorrhea without an alternative medical cause except if the medical cause is related to the NFPA or previous treatment of the NFPA including TSS); (2) is 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or (3) has undergone bilateral tubal ligation. d. A male patient who is not of reproductive potential is eligible without requiring the use of contraception. A male patient who is not of reproductive potential is defined as one who has undergone a successful vasectomy or has hypogonadism and is on androgen replacement. A successful vasectomy is defined as (1) microscopic documentation of azoospermia, or (2) a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post vasectomy. 5. A male or female patient who is of reproductive potential agrees to remain abstinent or use (or have their partner use) acceptable methods of highly effective contraception starting from the time of consent through 3 months after the completion of study therapy. True abstinence is defined as abstinence that is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of the study and withdrawal are not acceptable methods of contraception. Female patients must agree to two forms of birth control. Acceptable methods of highly effective birth control are double barrier contraception, combined or progestogen-only hormonal contraception that is associated with inhibition of ovulation, intrauterine device, and intrauterine hormone-releasing system. Female patients using a hormonal method of contraception must be accompanied with the use of a second, non-hormonal method of contraception (e.g. condom). 6. On a stable dose of hormone replacement therapy (i.e., growth hormone, thyroid hormone, corticosteroid, or sex hormone) for at least 3 months prior to Screening, if applicable. 7. Patients receiving treatment for hypertension must be controlled on a stable dose for at least one month, in the opinion of the Investigator, prior to Screening. 8. 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. 9. Be willing and able to complete all study assessments and procedures and to communicate effectively with the Investigator and site staff. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of
Exclusion criteria
Exclusion criteria: 1. Has undergone more than one TSS, or had TSS 3x the upper limit of normal (ULN); 13. Has uncontrolled diabetes (glycosylated haemoglobin (HbA1c) >8%); 14. Body Mass Index (BMI) 40 kg/m2; 15. A history of drug or alcohol abuse within the past one year as judged by the Investigator. 16. A cancer that has not been in complete remission for at least 5 years. Patients with squamous cell or basal cell carcinoma of the skin, localized cervical cancer, or localized prostate cancer are eligible if, in the opinion of the Investigator, the condition has been adequately diagnosed, and is determined to be clinically in remission, and the patient’s participation in the study would not represent a safety concern. 17. A history of a clinically significant allergic reaction or hypersensitivity, as judged by the Investigator, to any drug or any component of the study drug formulations used in the study. 18. On electrocardiogram (ECG), a corrected QT interval, Fridericia’s formula (QTcF) >450 ms in men and >470 ms in women or the presence of clinically significant abnormalities as determined by the investigator. 19. A history of major surgery within 4 weeks or minor surgery within 2 weeks of Day 1. 20. Any flu-like syndrome or other respiratory infection within 2 weeks of Day 1 or vaccination with attenuated live virus within 4 weeks of Day 1. 21. Participation in an investigational drug or device study within 30 days prior to Day 1. 22. Other prior or ongoing medical condition, physical findings, or laboratory abnormality that, in the Investigator's opinion, could adversely affect the safety of the patient, make it unlikely that the course of treatment or follow-up would
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of TBR-760 in adult patients with non-functioning pituitary adenomas (NFPAs) To assess the effect of TBR-760 on tumor remnant shrinkage in adult patients with NFPAs;Secondary Objective: To characterize the pharmacokinetic (PK) profile of TBR-760 in adult patients with NFPAs;Primary end point(s): TBR-760 safety and tolerability as measured by: o Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) o Change from baseline in 12-lead ECG parameters, clinical laboratory tests (chemistry, hematology, HbA1c, fasting blood glucose, coagulation, urine), gallbladder echography, and vital signs o Physical examination findings • The percentage of patients who have tumor remnant shrinkage at 52 weeks as measured by change in the calculated tumor volume;Timepoint(s) of evaluation of this end point: at weeks 13, 26 and 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The plasma PK profile of TBR-760 after SC administration in adult patients with NFPAs;Timepoint(s) of evaluation of this end point: at the following timepoints: 0.5, 1, 2, 6, 8, 12, 24, 48, 72, 120, and 168 hours after dose administration at Day 1 and Week 26 | — |
Countries
Belgium, Bulgaria, Czech Republic, France, Georgia, Germany, Hungary, Israel, Netherlands, Poland, United Kingdom, United States
Contacts
Public ContactNerissa Kreher
Tiburio Therapeutics, Inc.
Outcome results
None listed