Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Authorised, recruitment pending
Participants planned
17
Countries
1
Sites
1
Salivary Duct Carcinoma
Best Overall Response Rate
Key facts
- Sponsor
- Stichting Radboud universitair medisch centrum
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-03-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
Best Overall Response Rate
Secondary objectives 6
- Progression-free survival
- Overall survival
- Clinical benefit rate
- Disease control rate
- Safety
- Quality of life
Conditions and MedDRA coding
Salivary Duct Carcinoma
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Experimental arm Participants receiving capecitabine treatment according to routine clincial practice.
|
Not Applicable | None | Experimental arm: Participants receiving capecitabine. |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- Metadata will be shared in the Radboud Data Repository. Due to the fact SDC is a rare cancer, there is a high certainty that individual participant data couldbe linked to the participant.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-516956-16-00 | A phase 2 trial of capecitabine for recurrent and/or metastatic salivary duct carcinoma – CAESAR trial | Stichting Radboud universitair medisch centrum |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 11
- Pathologically/histologically proven diagnosis of (incurable) R/M SDC
- In case of AR+ HER2- disease: progression on or unwillingness to receive androgen blockade
- In case of AR+ HER2+ (IHC 3+ or IHC 2+ with positive ISH) disease: progression on anti-HER2 therapy and progression on or unwillingness to receive androgen blockade
- Progression on carboplatin-paclitaxel or unfit for carboplatin/paclitaxel
- Patients with measurable disease per RECIST v1.1 (Appendix I) or patients with bone metastases only who do not meet the criteria for measurable disease per RECIST v1.1
- Age ≥ 18 years
- ECOG 0-1
- Adequate bone marrow function (neutrophils ≥2.0 × 109/l, platelets ≥100 × 109/l, hemoglobin ≥5.8 mmol/l)
- Adequate liver function (total bilirubin ≤1.5 x upper limit of normal (ULN). For patients known with Gilbert’s Syndrome ≤ 3 x ULN is permitted. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN or ≤5.0 × ULN for patients with liver metastases)
- Adequate renal function (Serum creatinine ≤1.5 x ULN or creatinine clearance ≥ 30 ml/min)
- Written informed consent
Exclusion criteria 8
- History of severe fluoropyrimidine hypersensitivity
- Total absence of DPD-activity
- Usage of DPD-inhibitors within 4 weeks before start of treatment
- Inadequate swallowing capacity
- Patient with reproduction potential not implementing contraceptive measures
- Pregnancy or lactating women
- Uncontrolled illness
- Undergoing concomitant cancer treatments
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Best Overall Respone Rate
Secondary endpoints 6
- Progression-free survival
- Overall survival
- Clinical benefit rate
- Disease control rate
- Safety
- Quality of life
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP131876 · ATC
- Active substance
- Capecitabine
- Route of administration
- ORAL
- Max daily dose
- 2500 mg/m2 milligram(s)/square meter
- Max total dose
- 1800000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC06 — CAPECITABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Capecitabine is registered on the add-on list and has an off-label reimbursement status for 'certain types of salivary gland carcinoma', including SDC in the Netherlands.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Radboud universitair medisch centrum
- Sponsor organisation
- Stichting Radboud universitair medisch centrum
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- Carla van Herpen
Public contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- Carla van Herpen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 17 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Stichting Radboud universitair medisch centrum
Medical Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-516956-16-01_clean | 4.0 |
| Protocol (for publication) | D1_Protocol 2024-516956-16-01_trackchanges | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF CAESAR trial | 4.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Capecitabine | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ENG 2024-516956-16-01_clean | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ENG 2024-516956-16-01_trackchanges | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2024-516956-16-01_clean | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2024-516956-16-01_trackchanges | 4.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-07 | Netherlands | Acceptable 2025-03-10
|
2025-03-10 |