Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
34
Countries
1
Sites
1
The study population includes all patients aged over 18 with a neuroendocrine tumor grade I and II and a clinical indication for PRRT.
The effect of continued LA-SSA use on the absorbed dose in tumor lesions during PRRT.
Key facts
- Sponsor
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Jun 2024 → ongoing
- Decision date (initial)
- 2024-01-15
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- Neuroendocrine tumor research foundation (NETRF)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
The effect of continued LA-SSA use on the absorbed dose in tumor lesions during PRRT.
Secondary objectives 3
- The effect of continued LA-SSA use on the absorbed dose in normal tissues during PRRT
- The effect of continued LA-SSA use on the tumor-to-background ratio
- The effect of continued LA-SSA use on population pharmacokinetic parameters of [177Lu]Lu-HA-DOTATATE
Conditions and MedDRA coding
The study population includes all patients aged over 18 with a neuroendocrine tumor grade I and II and a clinical indication for PRRT.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Age ≥ 18 years
- Able to provide spoken and written informed consent for the trial
- Histopathological confirmed neuroendocrine tumor
- Fulfill the clinical criteria for PRRT
- At least one soft tissue lesion > 2 cm
- Aimed administered activity of 7400 MBq
- ECOG score (performance status) 0-2
Exclusion criteria 5
- Not possible to discontinue LA-SSA for 4-6 weeks
- Use of short-acting somatostatin analogues
- Inability to comply to the study procedures
- Factors that might affect the biodistribution (for example, indication for furosemide directly after PRRT infusion, limited fluid intake, any renal catheters, etc.)
- Pregnancy and lactating female patients
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The absorbed dose in target lesions measured on SPECT/CT imaging
Secondary endpoints 4
- The absorbed dose in normal tissue (kidneys, liver, spleen) measured on SPECT/CT imaging
- The bone marrow dose is determined using blood withdrawals and SPECT/CT imaging
- The uptake on SPECT/CT between target lesions and the liver and spleen measured on the 24 hours’ time point
- The effect of continued LA-SSA use on specific population pharmacokinetic parameters will be qualified using population pharmacokinetic modelling using the acquired SPECT/CT scans and blood samples for dosimetry
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP982054 · ATC
- Active substance
- Lanreotide
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 120 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- H01CB03 — LANREOTIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP38795107 · ATC
- Active substance
- Octreotide
- Substance synonyms
- Debio 4126
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- H01CB02 — OCTREOTIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
Lutetium (177LU) Oxodotreotide
SCP38104064 · ATC
- Active substance
- Lutetium (177LU) Oxodotreotide
- Substance synonyms
- 177LU-DOTA-TYR3-OCTREOTATE, 177LU-DOTA0-TYR3-OCTREOTATE, 177LU-DOTATATE, DOTATATE LUTENIUM LU-177, LUTETIUM (177LU) DOTATATE, LUTETIUM (177LU)-N-[(4,7,10-TRICARBOXYMETHYL-1,4,7,10-TETRAAZACYCLODODEC-1-YL)ACETYL]-D-PHENYLALANYL-L-CYSTEINYL-L-TYROSYL-D-TRYPTOPHANYL-L-LYSYL-L-THREONINYL-L-CYSTEINYL-L-THREONINE-CYCLIC(2-7)DISULPHIDE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 7400 MBq megabecquerel(s)
- Max total dose
- 29600 MBq megabecquerel(s)
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Authorised
- ATC code
- V10XX04 — LUTETIUM (177LU) OXODOTREOTIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- A magistral formula of the product will be used, using a licensed radionuclide for labeling instead of the licensed final preparation.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Sponsor organisation
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Address
- Plesmanlaan 121
- City
- Amsterdam
- Postcode
- 1066 CX
- Country
- Netherlands
Scientific contact point
- Organisation
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Contact name
- Department of Biometrics
Public contact point
- Organisation
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Contact name
- Department of Biometrics
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 34 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Nuclear medicine, Plesmanlaan 121, 1066 CX, Amsterdam
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-06-17 | 2024-06-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-505884-35-00 | 5 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_text for websites_Redacted | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Lanreotide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Octreotide | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2023-505884-35-00 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL 2023-505884-35-00 | 4 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-12 | Netherlands | Acceptable with conditions 2024-01-08
|
2024-01-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-05 | Netherlands | Acceptable 2024-05-21
|
2024-05-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-23 | Netherlands | Acceptable 2024-10-03
|
2024-10-03 |