Overview
Sponsor-declared trial summary
Breast cancer
The aims of this study are to investigate the impact of implementation of DPYD gene test on the safety and efficacy of fluoropyrimidine therapy in Finnish patients and to search for novel genetic variants and other individual characteristics associated with the efficacy and safety of cytostatic therapies.
Key facts
- Sponsor
- HUS-Yhtymae
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Oct 2019 → 17 Mar 2025
- Decision date (initial)
- 2024-10-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518448-20-00
- EudraCT number
- 2018-002255-15
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenetic, Pharmacokinetic
The aims of this study are to investigate the impact of implementation of DPYD gene test on the safety and efficacy of fluoropyrimidine therapy in Finnish patients and to search for novel genetic variants and other individual characteristics associated with the efficacy and safety of cytostatic therapies.
Conditions and MedDRA coding
Breast cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Signed informed consent
- Age ≥18 years
- Diagnosed breast cancer or colon cancer, which is treated at Helsinki University Central Hospital Cancer Center, in Oulu University Hospital or in Turku University Central Hospital
- Planned fluoropyrimidine medication
- The result of the DPYD gene test is available before starting fluodopyrimidine medication.
Exclusion criteria 3
- A person referred to in Sections 7-10 of the Medical Research Act (disabled, a minor, pregnant, breastfeeding or a prisoner)
- Contraindication to planned fluoropyrimidine medication
- Fluoropyrimidine medication as part of chemoradiotherapy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The concentrations of fluorouracil, tegafur, and capecitabine and their metabolites and pharmacokinetic variables in plasma and fingertip capillary blood samples.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
Teysuno 15 mg/4.35 mg/11.8 mg hard capsules
PRD538060 · Product
- Active substance
- Tegafur
- Substance synonyms
- N1-(2-TETRAHYDROFURYL)-5-FLUOROURACIL
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 99 mg milligram(s)
- Max total dose
- 99 mg milligram(s)
- Max treatment duration
- 99 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC53 — TEGAFUR, COMBINATIONS
- Marketing authorisation
- EU/1/11/669/001
- MA holder
- NORDIC GROUP B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Capecitabine Orion 150 mg kalvopäällysteiset tabletit
PRD1625260 · Product
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 99 mg milligram(s)
- Max total dose
- 99 mg milligram(s)
- Max treatment duration
- 99 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC06 — CAPECITABINE
- Marketing authorisation
- 31391
- MA holder
- ORION CORPORATION
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fluorouracil Accord 50 mg/ml injektio-/infuusioneste, liuos
PRD1972816 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 99 ml millilitre(s)
- Max total dose
- 99 ml millilitre(s)
- Max treatment duration
- 99 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- 23977
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-Yhtymae
- Sponsor organisation
- HUS-Yhtymae
- Address
- Stenbackinkatu 9
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-Yhtymae
- Contact name
- HUS Diagnostic Center, Clinical Pharmacology unit, Biomedicum
Public contact point
- Organisation
- HUS-Yhtymae
- Contact name
- HUS Diagnostic Center, Clinical Pharmacology unit, Biomedicum
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ended | 1,000 | 3 |
| 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 |
|---|---|---|---|---|---|
| Finland | 2019-10-17 | 2025-03-17 | 2019-10-17 | 2025-02-26 |
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) | DPDIMP_1-tutkimus_Tutkimussuunnitelma julkinen | 1 |
| Recruitment arrangements (for publication) | Transitiotutkimus | 1 |
| Subject information and informed consent form (for publication) | DPDIMP_1-tutkimus_Suostumus | 1 |
| Subject information and informed consent form (for publication) | DPDIMP_1-tutkimus_Tiedote | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | DPDIMP_1-tutkimus_Valmisteyhteenveto fluorourasiili | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | DPDIMP_1-tutkimus_Valmisteyhteenveto kapesitabiini | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | DPDIMP_1-tutkimus_Valmisteyhteenveto tegafuuri | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Finland | Acceptable 2024-10-29
|
2024-10-29 |