Overview
Sponsor-declared trial summary
Non-functioning pituitary adenoma
The main objective of the study is to evaluate the effect of medical treatment with cabergoline in non-functioning pituitary adenomas.
Key facts
- Sponsor
- St. Olavs Hospital HF
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Sep 2014 → ongoing
- Decision date (initial)
- 2024-11-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-510039-12-00
- EudraCT number
- 2012-001338-32
- ClinicalTrials.gov
- NCT02288962
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
The main objective of the study is to evaluate the effect of medical treatment with cabergoline in non-functioning pituitary adenomas.
Conditions and MedDRA coding
Non-functioning pituitary adenoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- A previously untreated non-functioning pituitary macroadenoma (largest diameter ≥ 10 mm) with either demonstrated growth on repeated MRI scans or ≤ 2 mm distance to chiasma opticum OR a residual non-functioning pituitary adenoma after surgery (largest diameter ≥ 5 mm) that is either extrasellar and/or with documented growth after surgical treatment of a non-functioning pituitary macroadenoma
Exclusion criteria 1
- 1. Clear indication for surgery at the time of inclusion 2. Previous radiation therapy 3. Pituitary surgery the last 6 months 4. Previous apoplexy/bleeding in the adenoma 5. Pregnancy or lactation 6. Contraindications for cabergoline treatment • Known cardiac valvular disease • Known pulmonal, pericardial or retroperitoneal fibrosis • Clinical significant liver insufficiency • Use of medications that interact with cabergoline 7. Unfit to participate due to any other reason
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- • The change in tumour volume during the main study of two years. This includes the percentage and absolute change in tumour volume, but also the number of patients with significant tumour shrinkage or tumour growth (defined by ≥ 10 % or ≥ 2 mm shrinkage/growth in at least one dimension).
Secondary endpoints 1
- • The need for surgical and/or radiation treatment during the study period • The development of new pituitary failure or changed pituitary function during the study, or new or changed visual field defects or other cranial nerve affections • The change in tumour’s distance to chiasma opticum (mm) • The response on gonadotropins (FSH, LH) and/or their subunits, particularly the α-subunit. A possible correlation between the tumour size response and the hormone levels and change during treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD422335 · Product
- Active substance
- Cabergoline
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0.29 mg milligram(s)
- Max total dose
- 208 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- G02CB03 — CABERGOLINE
- Marketing authorisation
- 7843
- MA holder
- PFIZER AS
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
St. Olavs Hospital HF
- Sponsor organisation
- St. Olavs Hospital HF
- Address
- Prinsesse Kristinas G. 3
- City
- Trondheim
- Postcode
- 7030
- Country
- Norway
Scientific contact point
- Organisation
- St. Olavs Hospital HF
- Contact name
- Stine Lyngvi Fougner
Public contact point
- Organisation
- St. Olavs Hospital HF
- Contact name
- Stine Lyngvi Fougner
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruitment ended | 60 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2014-09-01 | 2014-09-10 | 2024-12-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PROTOCOL EU CT 2023-510039-12-00 public | 5 |
| Protocol (for publication) | D1_PROTOCOL EU CT 2023-510039-12-00 with track changes | 5 |
| Recruitment arrangements (for publication) | K1_Recruitment CTIS | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC cabergoline pr 2020 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-28 | Norway | Acceptable 2024-11-15
|
2024-11-18 |