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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05936359
Registration number
NCT05936359
Ethics application status
Date submitted
21/06/2023
Date registered
7/07/2023
Titles & IDs
Public title
A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
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Scientific title
A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
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Secondary ID [1]
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2022-502514-86-00
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Secondary ID [2]
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INCA 33989-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myeloproliferative Neoplasms
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - INCA033989
Treatment: Drugs - Ruxolitinib
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.
Treatment: Drugs: INCA033989
INCA033989 will be administered at protocol defined dose.
Treatment: Drugs: Ruxolitinib
Rux will be administered according to Prescribing Information/SmPC.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
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Timepoint [1]
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Up to 28 days
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Primary outcome [2]
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Number of participants with Treatment-emergent Adverse Events (TEAEs)
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Assessment method [2]
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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
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Timepoint [2]
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Up to 3 years and 60 days
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Primary outcome [3]
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Number of participants with TEAEs leading to dose modification or discontinuation
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Assessment method [3]
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Number of participants with TEAEs leading to dose modification or discontinuation.
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Timepoint [3]
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Up to 3 years and 60 days
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Secondary outcome [1]
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Participants with MF: Response using the revised IWG-MRT and ELN response criteria for MF
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Assessment method [1]
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Defined as the percentage of participants with Response using the revised IWG-MRT and ELN response criteria.
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Timepoint [1]
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Up to 3 years and 60 days
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Secondary outcome [2]
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Participants With MF: Percentage of participants achieving spleen volume reduction as defined in the protocol
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Assessment method [2]
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Defined as percentage of participants with a protocol defined Spleen Volume Reduction.
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Timepoint [2]
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Up to 3 years and 60 days
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Secondary outcome [3]
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Participants with MF with symptomatic anemia: Anemia Response
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Assessment method [3]
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For non transfusion-dependent (TD) participants: An Hb increase relative to baseline as defined in the protocol if non-TD at baseline. For TD participants: Achieving transfusion independency (TI) as defined in the protocol.
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Timepoint [3]
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Up to 3 years and 60 days
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Secondary outcome [4]
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Participants With ET: Response Rate
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Assessment method [4]
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Defined as the proportion of participants with Complete Response or Partial Response when treated with study drug.
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Timepoint [4]
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Up to 3 years and 60 days
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Secondary outcome [5]
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Participants With ET: Mean change from baseline of total symptom score (TSS)
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Assessment method [5]
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Mean change of TSS from baseline.
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Timepoint [5]
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Up to 3 years and 60 days
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Secondary outcome [6]
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Mean change in disease-related allele burden
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Assessment method [6]
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Mean change in disease-related allele burden.
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Timepoint [6]
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Up to 3 years and 60 days
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Secondary outcome [7]
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Pharmacokinetics Parameter: Cmax of INCA33989
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Assessment method [7]
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Defined as maximum observed plasma concentration of INCA33989.
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Timepoint [7]
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Up to 3 years and 60 days
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Secondary outcome [8]
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Pharmacokinetics Parameter: Tmax of INCA033989
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Assessment method [8]
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Defined as the time to reach the maximum plasma concentration of INCA33989.
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Timepoint [8]
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Up to 3 years and 60 days
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Secondary outcome [9]
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Pharmacokinetics Parameter: Cmin of INCA33989
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Assessment method [9]
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Defined as the minimum observed plasma concentration of INCA33989.
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Timepoint [9]
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Up to 3 years and 60 days
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Secondary outcome [10]
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Pharmacokinetics Parameter: AUC(0-t) of INCA33989
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Assessment method [10]
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Defined as the area under the concentration-time curve up to the last measurable concentration of INCA33989.
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Timepoint [10]
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Up to 3 years and 60 days
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Secondary outcome [11]
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Pharmacokinetics Parameter: AUC 0-8 of INCA33989
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Assessment method [11]
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Defined as the area under the concentration-time curve from 0 to infinity of INCA33989.
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Timepoint [11]
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Up to 3 years and 60 days
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Secondary outcome [12]
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Pharmacokinetics Parameter: CL/F of INCA33989
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Assessment method [12]
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Defined as the apparent oral dose clearance of INCA33989.
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Timepoint [12]
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Up to 3 years and 60 days
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Secondary outcome [13]
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Pharmacokinetics Parameter: Vz/F of INCA33989
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Assessment method [13]
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Defined as the apparent oral dose volume of distribution of INCA33989.
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Timepoint [13]
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Up to 3 years and 60 days
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Secondary outcome [14]
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Pharmacokinetics Parameter: t1/2 of INCA33989
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Assessment method [14]
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Defined as the apparent terminal phase disposition half-life of INCA33989.
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Timepoint [14]
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Up to 3 years and 60 days
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/09/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/02/2028
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Actual
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Sample size
Target
225
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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Royal Brisbane and Women'S Hospital - Herston
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Recruitment hospital [2]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [3]
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Peter Maccallum Cancer Centre - Melbourne
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Recruitment hospital [4]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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04029 - Herston
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Recruitment postcode(s) [2]
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05000 - Adelaide
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Recruitment postcode(s) [3]
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03000 - Melbourne
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Recruitment postcode(s) [4]
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03004 - Melbourne
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Ontario
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Canada
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State/province [2]
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Quebec
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Denmark
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State/province [3]
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Odense C
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Denmark
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State/province [4]
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Roskilde
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Denmark
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State/province [5]
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Vejle
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Country [6]
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France
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State/province [6]
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Bordeaux
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Country [7]
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France
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State/province [7]
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Nimes
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Country [8]
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France
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Paris
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France
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State/province [9]
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Villejuif Cedex
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Germany
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State/province [10]
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Aachen
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Germany
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State/province [11]
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Halle
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Germany
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State/province [12]
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ULM
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Country [13]
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Italy
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State/province [13]
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Bologna
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Italy
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State/province [14]
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Firenze
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Italy
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State/province [15]
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Milan
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Japan
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State/province [16]
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Chiba
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Japan
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State/province [17]
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Kagoshima
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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State/province [20]
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TSU
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Spain
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State/province [21]
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Madrid
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Spain
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State/province [22]
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Valencia
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United Kingdom
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State/province [23]
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London
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United Kingdom
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State/province [24]
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Manchester
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Country [25]
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United Kingdom
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State/province [25]
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Incyte Corporation
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT05936359
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Incyte Medical Monitor
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Address
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Incyte Corporation
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Incyte Corporation Call Center (US)
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Address
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Country
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Phone
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1.855.463.3463
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05936359