Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
100
Countries
1
Sites
1
Neuroendocrine Tumor
To investigate is it is better for patients with NET to receive dosimetry based PRRT compared to standard dose PRRT
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517240-62-00
- EudraCT number
- 2019-002450-23
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To investigate is it is better for patients with NET to receive dosimetry based PRRT compared to standard dose PRRT
Conditions and MedDRA coding
Neuroendocrine Tumor
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Male or female patients > 18 years of age 2. NEN confirmed by histology 3. Clinical, PET/CT or CT proven progression despite standard treatment with somatostatin analogues, targeted therapy (Everolimus, sunitinib), chemotherapy (STZ/5-FU, temozolomide/capecitabine) OR intolerable side effects caused by these standard treatment OR unmanageable carcinoid symptoms 4. WHO/ ECOG Performance Status of 0-2 5. Life expectancy >6 months 6. Uptake higher than liver in primary tumor or metastases on Ga-DOTATOC PET/CT (Krenning 3 or 4), if the scan is more than 3 months old at inclusion time, a new scan should be done. 7. Adequate organ function as defined by: • Adequate kidney function: Patient glomerular filtration rate >30 ml/min measured by Tc-DTPA clearance • Adequate bone marrow function: • WBC ≥ 2.0 x 109/L • Platelets ≥ 100 x 109/L • Hb ≥ 6 mmol/l (≥9.67 g/dL) 8. Willingness and ability to comply with scheduled visits for SPECT/CT scans, treatment plans, laboratory tests and other study procedures. 9. Written informed consent obtained prior to any screening procedures
Exclusion criteria 1
- 1. Tumor amenable to surgery and/or radiofrequency ablation 2. Patients who are unable to stay isolated for 24 hours 3. Previous PRRT 4. Female patients who are pregnant or lactating. Women who are of childbearing potential (defined as all women physiologically capable of becoming pregnant) have to practice an effective method of contraception/birth control. Fertile female patients have to take a urinary pregnancy test, to ensure that they are not pregnant, before they can enter the study. After entering the study, they have to use effective contraception during the study period and 6 months after. Effective contraception methods include: • Use of oral, injected or implanted hormonal methods of contraception or • Placement of an intrauterine device (IUD) or intrauterine system (IUS) • Total abstinence or patient sterilization (male or female) 5. Male patients are not allowed to conceive pregnancy for 6 months after last treatment cycle 6. Known to be hypersensitive to any component of the Lu-177-DOTATOC 7. Patients with meningioma
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- • Difference in progression free survival between NEN patients treated with dosimetry based versus standard PRRT. Defined as time from randomization to documented disease progression or death by any cause, evaluated by CT, RECIST 1.1.
Secondary endpoints 1
- • Difference in tumor dose between dosimetry based and standard PRRT treatment groups • Difference in kidney toxicity between dosimetry based and standard PRRT treatment groups, measured by creatine, eGFR, cystatin-c, Tc-DTPA clearance, and kidney fibrosis markers PRO-6, C3M and LAMC1. • Difference in bone marrow function between dosimetry based and standard PRRT treatment groups, measured by hemoglobin, white blood cells, platelets. • Difference in subjective side effects between dosimetry bas
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11545042 · Product
- Active substance
- Lutetium (177LU) Edotreotide
- Substance synonyms
- 177Lu-DOTATOC, [177Lu]Lu-DOTA-d-Phe-Cys-Tyr-d-Trp-Lys-Thr-Cys-Thr(ol) (cyclo 2-7), LUTETIUM LU177 EDOTREOTIDE, Dotatoc Lu-177, EDOTREOTIDE LUTETIUM LU-177
- Pharmaceutical form
- INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 27.5 GBq gigabecquerel(s)
- Max total dose
- 104.5 GBq gigabecquerel(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- AARHUS UNIVERSITY HOSPITAL
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/14/1269
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Anne Arveschoug
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Anne Arveschoug
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring, Code 9 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 100 | 1 |
| 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 |
|---|---|---|---|---|---|
| Denmark | 2024-11-04 | 2024-11-04 |
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) | Protokol | 5 |
| Recruitment arrangements (for publication) | Placeholder document | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation | 5 |
| Subject information and informed consent form (for publication) | Samtykkeerklring | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Refer to Investigator Brochure | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-11 | Denmark | Acceptable 2024-10-31
|
2024-11-04 |