Overview
Sponsor-declared trial summary
Head and neck squamous cell carcinoma (HNSCC)
• To assess dosimetry, most optimal time point for imaging (Stage I), and safety of [18F]olaparib PET (Stage I + II). • To determine the correlation between tu-mour [18F]-olaparib uptake and tumour PARP-1 expression levels on tumour biopsy (Stage I + II).
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-04-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- UMCG Cancer Research Fund
External identifiers
- EU CT number
- 2024-511962-34-00
- ClinicalTrials.gov
- NCT06482307
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Safety
• To assess dosimetry, most optimal time point for imaging (Stage I), and safety of [18F]olaparib PET (Stage I + II).
• To determine the correlation between tu-mour [18F]-olaparib uptake and tumour PARP-1 expression levels on tumour biopsy (Stage I + II).
Secondary objectives 1
- • To evaluate changes in tumour [18F]-olaparib uptake, as a read-out of DNA damage, during treatment with platinum-based chemoradio-therapy, and its correlation with changes in PARP protein expression (Stage II).
Conditions and MedDRA coding
Head and neck squamous cell carcinoma (HNSCC)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Patients >18y, with biopsy-proven HPV-negative HNSCC, or patients >40y with HPV-positive HNSCC and high-risk features (i.e. > 10 smoke packs/year AND ≥N2b)
- Treatment with chemoradiotherapy using platinum-based chemotherapy is anticipated
- Recent archival tumour tissue (<8 weeks prior to inclusion) should be available with sufficient residual material for determination of tumour PARP1 levels
- Presence of a tumour lesion ≥10 mm in diameter
- ECOG performance status 0-2
- Negative pregnancy test in women with childbearing potential
- Life expectancy >3 months
- Signed written informed consent and able to comply with the protocol
- For stage II only: re-biopsy should be deemed feasible by the investigators (as-sessed by head-and-neck surgeon)
Exclusion criteria 2
- Recent treatment with PARP inhibitors or other investigational therapies <30 days.
- Presence of significant co-morbidities that make participation in the study undesirable according to the treating physician.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- • Dose-activity curves for healthy organs
- • Tumour: background ratio at different timepoints post-injection
- • AEs until 30 days post-injection
- • Correlation between standardised uptake value of [18F]-olaparib in tumour lesions, and PARP1 expression levels determined by immunohistochemistry
Secondary endpoints 2
- • Absolute and percentage increase in tumour [18F]-olaparib standardised uptake value after one week of chemoradiation compared to baseline tumour [18F]-olaparib standardised uptake value.
- • Correlation between standardised uptake value of [18F]-olaparib in tumour lesions, and PARP1 expression levels determined by immunohistochemistry after one week of chemoradiation.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11647787 · Product
- Active substance
- Olaparib
- Substance synonyms
- AZD-2281, AZD2281
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Not Authorised
- ATC code
- V09IX — OTHER DIAGNOSTIC RADIOPHARMACEUTICALS FOR TUMOUR DETECTION
- MA holder
- UNIVERSITY MEDICAL CENTER GRONINGEN
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- M. van Kruchten
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- M. van Kruchten
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-511962-34-00 - for publication | 3 |
| Protocol (for publication) | F3_Radiation_safety_statement_Olaparib_Quadra | 1 |
| Recruitment arrangements (for publication) | K1_recruitment procedure NL 2024-511962-34-00 | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2024-5114962-34-00 | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC lynparza-epar-product-information_en | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Dutch 2024-511962-34-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis English 2024-511962-34-00 | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-21 | Netherlands | Acceptable 2025-04-22
|
2025-04-22 |