A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Life expectancy \> 6 months.
• Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).
• Existing documentation from a qualified local laboratory of CALR exon-9 mutation.
• Participants with MF and ET as defined in the protocol.
Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Royal Brisbane and Women'S Hospital
RECRUITING
Herston
Peter Maccallum Cancer Centre
RECRUITING
Melbourne
The Alfred Hospital
RECRUITING
Melbourne
Canada
Hopital Maisonneuve-Rosemont, Montreal, Qc
RECRUITING
Montreal
Princess Margaret Cancer Center
RECRUITING
Toronto
Denmark
Odense University Hospital
WITHDRAWN
Odense C
Sjaellands Universitetshospital
RECRUITING
Roskilde
Vejle Hospital
RECRUITING
Vejle
France
Institut Bergonie
RECRUITING
Bordeaux
Chu Nimes
RECRUITING
Nîmes
Hospital Saint Louis
RECRUITING
Paris
Institut Gustave Roussy
RECRUITING
Villejuif
Germany
University Medical Center Rwth Aachen
RECRUITING
Aachen
Universitatsklinikum Halle (Saale)
RECRUITING
Halle
Universitatsklinikum Ulm
RECRUITING
Ulm
Italy
Aou Policlinico S. Orsola-Malpighi
RECRUITING
Bologna
Azienda Ospedaliero-Universitaria Careggi (Aouc)
RECRUITING
Florence
Fondazione Irccs Ca Granda Ospedale Maggiore
RECRUITING
Milan
Japan
National Cancer Center Hospital East
RECRUITING
Chiba
Kagoshima University Hospital
RECRUITING
Kagoshima
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Nippon Medical School Hospital
RECRUITING
Tokyo
Mie University Hospital
RECRUITING
Tsu
Spain
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitari I Politecnic La Fe
RECRUITING
Valencia
United Kingdom
Guys and St Thomas Nhs Foundation Trust
RECRUITING
London
The Christie Nhs Foundation Trust Uk
RECRUITING
Manchester
University of Oxford
RECRUITING
Oxford
Contact Information
Primary
Incyte Corporation Call Center (US)
medinfo@incyte.com
1.855.463.3463
Backup
Incyte Corporation Call Center (ex-US)
eumedinfo@incyte.com
+800 00027423
Time Frame
Start Date: 2023-09-25
Estimated Completion Date: 2028-02-29
Participants
Target number of participants: 225
Treatments
Experimental: Part 1a Dose Escalation Cohort Disease Group A - with MF
INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myelofibrosis (MF) will enroll in this group.
Experimental: Part 1a Dose Escalation Cohort Disease Group A - with ET
INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with with essential thrombocythemia (ET) will enroll in this group.
Experimental: Part 1a: Dose Escalation Cohort Disease Group B - with TGB-MF SubOpt R
INCA033989 will be administered at a protocol defined starting regimen in 28- day cycles and will allow for the evaluation of INCA033989 in combination with ruxolitinib to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myelofibrosis (MF) exhibiting suboptimal response (SubOpt R) will enroll in this group.
Experimental: Part 1b: Dose Expansion - with MF
INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) myelofibrosis MF will enroll in this group.
Experimental: Part 1b: Dose Expansion - with TGB-MF SubOpt R
INCA033989 will be administered as an add-on therapy in combination with ruxolitinibat at the RDE(s) identified during Part 1a. Participants with treatment Group B (TGB) MF SubOpt R will enroll in this group.
Experimental: Part 1b: Dose Expansion - with ET
INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) essential thrombocythemia (ET) will enroll in this group.
Experimental: Part 1c: Dose Expansion
INCA033989 will be administered at the dose level found to exhibit an overall positive benefit/risk as monotherapy or as combination therapy with Ruxolitinib. Participants with myelofibrosis (MF) will enroll in this group. The participants enrolled in the monotherapy arm will be offered the option to crossover to combination therapy with ruxolitinib if a suboptimal response to monotherapy is observed after 12 weeks.
Related Therapeutic Areas
Sponsors
Leads: Incyte Corporation