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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07008118
Registration number
NCT07008118
Ethics application status
Date submitted
29/05/2025
Date registered
6/06/2025
Date last updated
10/07/2025
Titles & IDs
Public title
A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms
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Scientific title
A Phase 1, Open-Label, Multicenter Study of INCA035784 in Participants With Myeloproliferative Neoplasms
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Secondary ID [1]
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INCA035784-101
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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 - INCA035784
Experimental: Part 1a: Dose escalation - INCA035784 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 myeloproliferative neoplasm (MPN) will enroll in this group.
Experimental: Part 1b: Dose expansion - INCA035784 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with myeloproliferative neoplasm (MPN) will enroll in this group.
Treatment: Drugs: INCA035784
INCA035784 will be administered at protocol defined dose.
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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 up to 90 days after the last dose of study drug.
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Timepoint [2]
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Up to approximately 2 years and 90 days
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Primary outcome [3]
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Number of participants with TEAEs leading to treatment interruption, discontinuation, or delay
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Assessment method [3]
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Number of participants with TEAEs leading to treatment interruption, discontinuation, or delay.
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Timepoint [3]
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Up to approximately 2 years and 90 days
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Secondary outcome [1]
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Number of participants with TEAEs leading to dose modification or discontinuation
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Assessment method [1]
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Number of participants with TEAEs leading to dose modification or discontinuation.
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Timepoint [1]
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Up to approximately 2 years and 90 days
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Secondary outcome [2]
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Participants with MF: Response using the revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) response criteria for myelofibrosis (MF)
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Assessment method [2]
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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 [2]
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Up to approximately 2 years and 90 days
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Secondary outcome [3]
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Participants with essential thrombocythemia (ET): Response using the revised IWG-MRT and ELN response criteria for ET
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Assessment method [3]
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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 [3]
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Up to approximately 2 years and 90 days
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Secondary outcome [4]
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Participants with myelodysplastic syndrome (MDS)/MPN: Response using the revised IWG-MRT response criteria for MDS/MPN
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Assessment method [4]
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Defined as the percentage of participants with Response using the revised IWG-MRT response criteria.
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Timepoint [4]
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Up to approximately 2 years and 90 days
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Secondary outcome [5]
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Participants with symptomatic anemia: Anemia response
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Assessment method [5]
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Anemia response as defined in the protocol.
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Timepoint [5]
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Up to approximately 2 years and 90 days
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Secondary outcome [6]
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Participants with spleen volume (SV) = 450 mL at baseline: Percentage of participants achieving spleen volume reduction of = 35% (SVR35)
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Assessment method [6]
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Defined as percentage of participants with a protocol defined Spleen Volume Reduction of = 35% (SVR35).
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Timepoint [6]
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Week 12 and Week 24
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Secondary outcome [7]
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Participants with SV = 450 mL at baseline: Percentage of participants achieving spleen volume reduction of = 25% (SVR25)
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Assessment method [7]
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Defined as percentage of participants with a protocol defined Spleen Volume Reduction of = 25% (SVR25).
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Timepoint [7]
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Week 12 and Week 24
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Secondary outcome [8]
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Percentage of participants achieving = 50% reduction from baseline of total symptom score (TSS)
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Assessment method [8]
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Defined as the percentage of participants achieving = 50% reduction from baseline of TSS.
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Timepoint [8]
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Week 12 and Week 24
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Secondary outcome [9]
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Mean change from baseline in TSS
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Assessment method [9]
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Mean change of TSS from baseline.
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Timepoint [9]
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Week 12 and Week 24
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Secondary outcome [10]
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Pharmacokinetics Parameter (PK): Cmax of INCA035784
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Assessment method [10]
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Defined as maximum observed plasma concentration of INCA035784.
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Timepoint [10]
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Up to approximately 2 years and 90 days
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Secondary outcome [11]
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Pharmacokinetics Parameter: Tmax of INCA035784
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Assessment method [11]
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Defined as the time to reach the maximum plasma concentration of INCA035784.
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Timepoint [11]
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Up to approximately 2 years and 90 days
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Secondary outcome [12]
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Pharmacokinetics Parameter: Cmin of INCA035784
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Assessment method [12]
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Defined as the minimum observed plasma concentration of INCA035784.
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Timepoint [12]
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Up to approximately 2 years and 90 days
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Secondary outcome [13]
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Pharmacokinetics Parameter: AUC(0-t) of INCA035784
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Assessment method [13]
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Defined as the area under the concentration-time curve up to the last measurable concentration of INCA035784.
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Timepoint [13]
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Up to approximately 2 years and 90 days
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Secondary outcome [14]
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Pharmacokinetics Parameter: AUC 0-8 of INCA035784
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Assessment method [14]
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Defined as the area under the concentration-time curve from 0 to infinity of INCA035784.
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Timepoint [14]
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Up to approximately 2 years and 90 days
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Secondary outcome [15]
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Pharmacokinetics Parameter: CL of INCA035784
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Assessment method [15]
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Defined as the apparent oral dose clearance of INCA035784.
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Timepoint [15]
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Up to approximately 2 years and 90 days
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Secondary outcome [16]
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Pharmacokinetics Parameter: Vz of INCA035784
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Assessment method [16]
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Defined as the apparent oral dose volume of distribution of INCA035784.
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Timepoint [16]
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Up to approximately 2 years and 90 days
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Secondary outcome [17]
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Pharmacokinetics Parameter: t1/2 of INCA035784
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Assessment method [17]
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Defined as the apparent terminal phase disposition half-life of INCA035784.
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Timepoint [17]
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Up to approximately 2 years and 90 days
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Eligibility
Key inclusion criteria
* Age 18 years or older at the time of signing the ICF
* ECOG performance status of 0 to 1 for the dose escalation (Part 1a) and 0 to 2 for the dose expansion (Part 1b)
* Documented CALR exon-9 mutation
* Confirmed diagnosis of MPN according to the 2022 ICC criteria:
* DIPSS+ intermediate-2/high-risk MF with prior JAKi, <20% blasts, and measurable spleen
* High-risk ET with platelets >450×10?/L
* Resistant, refractory, intolerant, or has lost response to =1 prior line of therapy for MF and =2 prior lines for ET
* No prior stem cell transplant and none planned within 6 months
* Minimum Laboratory Requirements:
* Platelet count =50 × 10?/L
* Absolute neutrophil count =1 × 10?/L
* International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =1.5 × upper limit of normal (ULN), unless receiving vitamin K antagonists
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 × ULN
* Total bilirubin <2 × ULN
* Estimated creatinine clearance >45 or >30 mL/min (depending on study part)
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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
* Major bleeding or thrombosis (e.g., stroke, DVT, PE) within the past 3 months
* Active or high-risk HBV, HCV, or HIV infection, or other chronic active infections requiring systemic treatment
* Active invasive cancer within the past 2 years, except certain early-stage or low-risk cancers (e.g., resected skin, cervical, thyroid, or prostate cancer)
* Pregnant or unwilling to avoid pregnancy or fathering a child during the study and for a defined period after the last dose.
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
30/07/2025
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Actual
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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
14/12/2029
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Macquarie University Hospital - Sydney
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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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The Alfred Hospital - Melbourne
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Recruitment hospital [4]
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Linear Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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02109 - Sydney
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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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03004 - Melbourne
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Recruitment postcode(s) [4]
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06009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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Illinois
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Country [4]
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United States of America
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State/province [4]
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Maryland
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Country [5]
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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New York
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Country [7]
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United States of America
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State/province [7]
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North Carolina
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Country [8]
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United States of America
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State/province [8]
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Utah
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Country [9]
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United States of America
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State/province [9]
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Wisconsin
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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 and tolerability of INCA035784 in participants with myeloproliferative neoplasms.
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Trial website
https://clinicaltrials.gov/study/NCT07008118
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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/NCT07008118
Download to PDF