Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
8
Countries
1
Sites
3
Myelofibrosis
To enable continued treatment and evaluation of safety in subjects receiving ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone.
Key facts
- Sponsor
- Incyte Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Nov 2024 → ongoing
- Decision date (initial)
- 2024-05-31
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Incyte Corporation
External identifiers
- EU CT number
- 2023-507225-42-00
- ClinicalTrials.gov
- NCT02955940
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy
To enable continued treatment and evaluation of safety in subjects receiving ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone.
Conditions and MedDRA coding
Myelofibrosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10028537 | Myelofibrosis | 100000004864 |
Regulatory references
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2020-003130-21 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Combination of PI3Kδ Inhibitor Parsaclisib and Ruxolitinib in Participants With Myelofibrosis, Estudio de fase III, aleatorizado, con doble ciego, controlado con placebo de la combinación del inhibidor de PI3Kδ parsaclisib y ruxolitinib en participantes con mielofibrosis, Studio di fase 3, randomizzato, in doppio cieco, controllato verso placebo sulla combinazione dell’inibitore di PI3Kd parsaclisib e di ruxolitinib in partecipanti affetti da mielofibrosi |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of ruxolitinib that has completed or been terminated.
- Currently tolerating treatment in the parent protocol.
- Currently benefiting from the treatment with ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone, as determined by the investigator.
- Have at least stable disease, as determined by the investigator.
- Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
- Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.
- Willingness to avoid pregnancy or fathering children based on the criteria below: a. Woman of nonchildbearing potential. b. Woman of childbearing potential who has a negative serum pregnancy test on Day 1 and who agrees to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from the first dose through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy (see Appendix A) should be communicated to the subject and their understanding confirmed. c. Man who agrees to take appropriate precautions to avoid fathering children (with at least 99% certainty) from the first dose through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy (see Appendix A) should be communicated to the subject and their understanding confirmed.
- Ability to comprehend and willingness to sign an informed consent form (ICF).
Exclusion criteria 4
- Has been permanently discontinued from study treatment in the parent study for any reason.
- Able to access ruxolitinib and/or background cancer therapy outside of the clinical study.
- Subjects with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the subject or compliance with the Protocol.
- Pregnant or breastfeeding woman.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To assess the frequency and types of adverse events and serious adverse events reported in subjects receiving ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD3949623 · Product
- Active substance
- Ruxolitinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 9999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/008
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling, repackaging
PRD3949635 · Product
- Active substance
- Ruxolitinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 9999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/005
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling, repackaging
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Incyte Corp.
- Sponsor organisation
- Incyte Corp.
- Address
- 1801 Augustine Cut Off
- City
- Wilmington
- Postcode
- 19803-4404
- Country
- United States
Scientific contact point
- Organisation
- Incyte Corp.
- Contact name
- Michael Stouffs
Public contact point
- Organisation
- Incyte Corp.
- Contact name
- Michael Stouffs
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring, Code 12, Code 5 |
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruiting | 6 | 3 |
| Rest of world
United States
|
— | 2 | — |
Investigational sites
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
N/A, Ul. Macieja Jakubowskiego 2, 30-688, Cracow
Instytut Hematologii I Transfuzjologii
Klinika Hematologii, Ul Indiry Gandhi 14, 02-776, Warsaw
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
N/A, Ul. Stanislawa Staszica 11, 20-081, Lublin
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 |
|---|---|---|---|---|---|
| Poland | 2024-11-05 | 2024-11-07 |
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_2023-507225-42-00_redacted | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Obtaining informed consent_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_PL | 2.1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Intercash-Data Protection and Privacy Policy_PL | N/A |
| Summary of Product Characteristics (SmPC) - Extract (for publication) | E2_SmPC_Jakavi_SOC | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Jakavi | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-507225-42-00_PL | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-08 | Poland | Acceptable 2024-05-27
|
2024-05-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-26 | Poland | Acceptable 2024-09-02
|
2024-09-06 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-05 | Poland | Acceptable 2024-09-02
|
2025-08-05 |