Overview
Sponsor-declared trial summary
Non small cell lung cancer (NSCLC), Mesothelioma, Thymoma
The main objective is to evaluate the haematological toxicity in patients who use pemetrexed with and without rescue therapy with folinic acid.
Key facts
- Sponsor
- Amphia Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Feb 2023 → 4 Sep 2024
- Decision date (initial)
- 2023-01-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Efficacy
The main objective is to evaluate the haematological toxicity in patients who use pemetrexed with and without rescue therapy with folinic acid.
Secondary objectives 4
- To evaluate the difference in haematological toxicity based on the CTCAE criteria for neutrophil count
- To evaluate the influence of baseline homocysteine plasma levels on occurrence of haematological toxicity.
- To evaluate the efficacy of the treatment with pemetrexed.
- To evaluate the incidence of treatment delay or dose reduction of pemetrexed.
Conditions and MedDRA coding
Non small cell lung cancer (NSCLC), Mesothelioma, Thymoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10027406 | Mesothelioma | 100000004864 |
| 21.1 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 20.0 | PT | 10043670 | Thymoma | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- ≥18 years old
- Eligible for treatment with pemetrexed-based chemotherapy based on indication.
- ECOG performance score of 0-2.
- Subject is able and willing to sign the Informed Consent Form.
Exclusion criteria 2
- Contraindications for treatment with folinic acid in line with the SmPC. a. Hypersensitivity to the active substance or to any of the excipients. b. Anaemia caused by vitamin B12 deficiency.
- The presence of clinically relevant drug-drug interactions, according to the current SmPC of folinic acid.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Difference in neutrophil count (*109/L) at day 8-10.
Secondary endpoints 4
- Grade neutropenia (according to the CTCAE version 5, 2017) at day 8-10
- Homocysteine plasma levels at baseline (μmol/L)
- Efficacy based on response CT after cycle 2 and 4 (categorical: response, partial response, progression)
- Incidence of discontinuation, dose delays and dose reductions.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD443268 · Product
- Active substance
- Calcium Folinate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 180 mg milligram(s)
- Max total dose
- 540 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AF03 — CALCIUM FOLINATE
- Marketing authorisation
- RVG 08997
- MA holder
- TEVA B.V
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amphia Hospital
- Sponsor organisation
- Amphia Hospital
- Address
- Molengracht 21
- City
- Breda
- Postcode
- 4818 CK
- Country
- Netherlands
Scientific contact point
- Organisation
- Amphia Hospital
- Contact name
- Marion van der Ham-Helmons
Public contact point
- Organisation
- Amphia Hospital
- Contact name
- Marion van der Ham-Helmons
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 50 | 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 |
|---|---|---|---|---|---|
| Netherlands | 2023-02-05 | 2024-09-04 | 2023-02-07 | 2024-09-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Abstract FLEX trial SUM-89700
|
2025-07-09T10:32:29 | Submitted | Summary of Results |
Documents 1 file
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Summary of results (for publication) | Abstract FLEX trial | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-20 | Netherlands | Acceptable 2023-01-12
|
2023-01-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-03-13 | Netherlands | Acceptable 2023-01-12
|
2023-03-13 |