Trial Title:
A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
NCT ID:
NCT05936359
Condition:
Myeloproliferative Neoplasms
Conditions: Official terms:
Neoplasms
Myeloproliferative Disorders
Conditions: Keywords:
Myeloproliferative Neoplasms
Ruxolitinib
Myelofibrosis
Essential thrombocythemia
CALR mutation
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
INCA033989
Description:
INCA033989 will be administered at protocol defined dose.
Arm group label:
Part 1a Dose Escalation Cohort Disease Group A - with ET
Arm group label:
Part 1a Dose Escalation Cohort Disease Group A - with MF
Arm group label:
Part 1a: Dose Escalation Cohort Disease Group B - with TGB-MF SubOpt R
Arm group label:
Part 1b: Dose Expansion - with ET
Arm group label:
Part 1b: Dose Expansion - with MF
Arm group label:
Part 1b: Dose Expansion - with TGB-MF SubOpt R
Arm group label:
Part 1c: Dose Expansion
Intervention type:
Drug
Intervention name:
Ruxolitinib
Description:
Rux will be administered according to Prescribing Information/SmPC.
Arm group label:
Part 1a: Dose Escalation Cohort Disease Group B - with TGB-MF SubOpt R
Arm group label:
Part 1b: Dose Expansion - with TGB-MF SubOpt R
Arm group label:
Part 1c: Dose Expansion
Other name:
Jakafi
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
- Active invasive malignancy over the previous 2 years.
- Active HBV/HCV, HIV.
- History of clinically significant or uncontrolled cardiac disease.
- Has undergone any prior allogenic or autologous stem-cell transplantation or such
transplantation is planned.
- Laboratory values outside the Protocol-defined ranges.
- Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time
within 4 weeks before the first dose of study treatment.
- Prior history of major bleeding, or thrombosis within the last 3 months prior to
study enrollment.
- Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy,
biological therapy, endocrine therapy, targeted therapy, antibody, or
hypomethylating agent used to treat the participant's disease within 5 half-lives or
28 days (whichever is shorter) before the first dose of study treatment.
- For TGBs only: Undergoing treatment with a potent/strong inhibitor or inducer of CYP
3A4/5 within 14 days or 5 half-lives (whichever is longer) before the first dose of
study treatment, or expected to receive such treatment during the study.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Royal Brisbane and Women'S Hospital
Address:
City:
Herston
Zip:
04029
Country:
Australia
Status:
Recruiting
Facility:
Name:
Royal Adelaide Hospital
Address:
City:
Adelaide
Zip:
05000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Peter Maccallum Cancer Centre
Address:
City:
Melbourne
Zip:
03000
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Alfred Hospital
Address:
City:
Melbourne
Zip:
03004
Country:
Australia
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Center
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Hopital Maisonneuve-Rosemont, Montreal, Qc
Address:
City:
Montreal
Zip:
QC H1T 2M4
Country:
Canada
Status:
Recruiting
Facility:
Name:
Odense University Hospital
Address:
City:
Odense C
Zip:
05000
Country:
Denmark
Status:
Withdrawn
Facility:
Name:
Sjaellands Universitetshospital
Address:
City:
Roskilde
Zip:
04000
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Vejle Hospital
Address:
City:
Vejle
Zip:
07100
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Institut Bergonie
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Recruiting
Facility:
Name:
Chu Nimes
Address:
City:
Nimes
Zip:
30029
Country:
France
Status:
Recruiting
Facility:
Name:
Hospital Saint Louis
Address:
City:
Paris
Zip:
75010
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif Cedex
Zip:
94805
Country:
France
Status:
Recruiting
Facility:
Name:
University Medical Center Rwth Aachen
Address:
City:
Aachen
Zip:
52074
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitatsklinikum Halle (Saale)
Address:
City:
Halle
Zip:
06120
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitatsklinikum Ulm
Address:
City:
ULM
Zip:
89081
Country:
Germany
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliero-Universitaria Careggi (Aouc)
Address:
City:
Firenze
Zip:
50134
Country:
Italy
Status:
Recruiting
Facility:
Name:
Fondazione Irccs Ca Granda Ospedale Maggiore
Address:
City:
Milan
Zip:
20122
Country:
Italy
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Chiba
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kagoshima University Hospital
Address:
City:
Kagoshima
Zip:
890-8520
Country:
Japan
Status:
Recruiting
Facility:
Name:
Osaka Metropolitan University Hospital
Address:
City:
Osaka
Zip:
545-8586
Country:
Japan
Status:
Recruiting
Facility:
Name:
Nippon Medical School Hospital
Address:
City:
Tokyo
Zip:
113-8603
Country:
Japan
Status:
Recruiting
Facility:
Name:
Mie University Hospital
Address:
City:
TSU
Zip:
514-0001
Country:
Japan
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari I Politecnic La Fe
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Recruiting
Facility:
Name:
Guys and St Thomas Nhs Foundation Trust
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
The Christie Nhs Foundation Trust Uk
Address:
City:
Manchester
Zip:
M20 4BV
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
University of Oxford
Address:
City:
Oxford
Zip:
OX3 7LE
Country:
United Kingdom
Status:
Recruiting
Start date:
September 25, 2023
Completion date:
February 29, 2028
Lead sponsor:
Agency:
Incyte Corporation
Agency class:
Industry
Source:
Incyte Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05936359
