Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
100
Countries
1
Sites
2
Metastatic renal cell carcinoma (mRCC)
To evaluate the effectiveness of folic acid supplement versus PLACEBO on reducing mucositis (nasal,oral, pharyngeal, anal, or genital) according to CTCAE v 4.0.
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
- 22 Dec 2017 → ongoing
- Decision date (initial)
- 2024-09-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515413-18-00
- EudraCT number
- 2016-001193-15
- ClinicalTrials.gov
- NCT03581773
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate the effectiveness of folic acid supplement versus PLACEBO on reducing mucositis (nasal,oral, pharyngeal, anal, or genital) according to CTCAE v 4.0.
Secondary objectives 1
- To evaluate the frequency and degree of mucositis (nasal, oral, pharyngeal, anal, or genital) according to patient-reported outcomes (PRO) by self assessment questionnaire using National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NCCN-FACT FKSI-19) and a modified version of the M.D. Anderson Symptom Inventory (MDASI) for RCC. To evaluate the median time to effect of study drug according to CTCAE v 4.0 and PRO. To evaluate the frequency of TKI/mTOR dose reductions in the two groups. To evaluate the frequency of TKI/mTOR/IT treatment discontinuations in the two groups. To evaluate the frequency of TKI/mTOR/IT treatment withdrawals in the two groups. To evaluate the frequency and degree of GI adverse events according to CTCAE v 4.0 and PRO. To evaluate the frequency and degree of hand-foot according to CTCAE v 4.0 and PRO. To evaluate the quality of life according to CTCAE v 4.0 and PRO. To evaluate the degree of TKI, IT and mTOR inhibitor-specific adverse events according to CTCAE v 4.0 and PRO.
Conditions and MedDRA coding
Metastatic renal cell carcinoma (mRCC)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- 1. Patients displaying CTCAE ≥2 mucositis during TKI or mTOR inhibitor or IT treatment.
- Signed written informed consent obtained prior to any study specific procedures.
- Patient must be willing and able to comply with the protocol.
- Age ≥ 18
- Biopsy proven locally advanced or metastatic renal cell carcinoma.
- Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.
- Fertile women of childbearing potential (<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilization).
- Karnofsky Performance status ≥ 60%.
Exclusion criteria 2
- Known hypersensitivity to folic acid.
- Use of prednisolone more than 10 mg daily.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is the degree of CTCAE mucositis (nasal, oral, pharyngeal, anal, or genital) according to the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE).
Secondary endpoints 8
- The frequency and degree of mucositis (nasal, oral, pharyngeal, anal, or genital) according to patient-reported outcomes (PRO) by self assessment questionnaire using National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NCCN-FACT FKSI-19) and a modified version of the M.D. Anderson Symptom Inventory (MDASI) for RCC.
- The median time to effect of study drug according to CTCAE 4.0 and PRO.
- The frequency of TKI/mTOR dose reductions in the two groups
- The frequency of TKI/mTOR/IT treatment discontinuations in the two groups
- The frequency of TKI/mTOR/IT treatment withdrawals in the two groups
- The frequency and degree of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO.
- The frequency and degree of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO.
- The quality of life in the two groups according to NCCN-FACT FKSI-19 and the M.D. Anderson Symptom Inventory for RCC.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD342108 · Product
- Active substance
- Folic Acid
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 420 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- B03BB01 — FOLIC ACID
- Marketing authorisation
- 7152
- MA holder
- MEDILINK A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Placebo for Folinsyre 5mg Tabletter MediLink.
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
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
- Niels Fristrup
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Niels Fristrup
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 100 | 2 |
| 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 | 2017-12-22 | 2024-09-10 |
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) | D1_Protocol 2024-515413-18-00 | 1 |
| Recruitment arrangements (for publication) | Placeholder document 2024-515413-18-00 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Folimet | 1 |
| Synopsis of the protocol (for publication) | Placeholder document 2024-515413-18-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-19 | Denmark | Acceptable 2024-09-03
|
2024-09-10 |