A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
Condition(s) studied
Investigational drug(s) / intervention(s)
INCA033989: INCA033989 will be administered at protocol defined dose.
Ruxolitinib: Rux will be administered according to Prescribing Information/SmPC.
Study summary
This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.
Eligibility
Primary outcome measure(s)
- Number of participants with Dose Limiting Toxicities (DLTs) — Up to 28 days
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol. - Number of participants with Treatment-emergent Adverse Events (TEAEs) — Up to 3 years and 60 days
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with ruxolitinib - Number of participants with TEAEs leading to dose modification or discontinuation — Up to 3 years and 60 days
Number of participants with TEAEs leading to dose modification or discontinuation.
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| Royal Brisbane and Women'S Hospital | Herston | Queensland | |
| Royal Adelaide Hospital | Adelaide | South Australia | |
| Peter Maccallum Cancer Centre | Melbourne | Victoria | |
| The Alfred Hospital | Melbourne | Victoria | |
| Princess Margaret Cancer Center | Toronto | Ontario | |
| Hopital Maisonneuve-Rosemont, Montreal, Qc | Montreal | Quebec | |
| Sjaellands Universitetshospital | Roskilde | Denmark | |
| Vejle Hospital | Vejle | Denmark | |
| Institut Bergonie | Bordeaux | France | |
| Chu Nimes | Nîmes | France | |
| Hospital Saint Louis | Paris | France | |
| Institut Gustave Roussy | Villejuif | France | |
| University Medical Center Rwth Aachen | Aachen | Germany | |
| Universitatsklinikum Halle (Saale) | Halle | Germany | |
| Universitätsklinikum Ulm | Ulm | Germany | |
| Aou Policlinico S. Orsola-Malpighi | Bologna | Italy | |
| Azienda Ospedaliero-Universitaria Careggi (Aouc) | Florence | Italy | |
| Fondazione Irccs Ca Granda Ospedale Maggiore | Milan | Italy | |
| National Cancer Center Hospital East | Chiba-ken | Japan | |
| Kagoshima University Hospital | Kagoshima | Japan | |
| Osaka Metropolitan University Hospital | Osaka | Japan | |
| Nippon Medical School Hospital | Tokyo | Japan | |
| Mie University Hospital | Tsu | Japan | |
| Hospital Universitario 12 de Octubre | Madrid | Spain | |
| Hospital Universitari I Politecnic La Fe | Valencia | Spain | |
| Guys and St Thomas Nhs Foundation Trust | London | United Kingdom | |
| The Christie Nhs Foundation Trust Uk | Manchester | United Kingdom | |
| University of Oxford | Oxford | United Kingdom |
On this site
📄 Jakafi (ruxolitinib) drug profile →More Incyte Corporation trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05936359 on ClinicalTrials.gov ↗ ← All trials in France