Study of INCA036978 in Participants With Myeloproliferative Neoplasms
ConditionMyeloproliferative Neoplasms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIncyte Corporation
About this trial
This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)s of INCA036978 administered as monotherapy and in combination with a standard disease-directed therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Life expectancy > 6 months.
Willingness to undergo a pretreatment and limited on-study BM biopsies and aspirates (as appropriate to disease).
Participants with MF, PV and ET as defined in the protocol.
Disqualifiers
Presence of any hematological malignancy other than MF, PV, or ET.
Malignancy within the last 3 years prior to enrollment.
Acute or chronic HBV, Active HCV or known HIV or tuberculosis infection.
Clinically significant or uncontrolled cardiac disease.
Trial design
Design model
Sequential
Treatments tested in this trial
INCA036978
DrugINCA036978 will be administered at protocol defined dose.
Standard disease-directed therapy
DrugA standard disease-directed therapy will be administered according to Prescribing Information/SmPC.
Treatment groups
218 Participants
are divided into 4 treatment groupsGroup A: Part 1a: Dose EscalationExperimental treatment 1 intervention
Group B: Part 1b: Dose EscalationExperimental treatment 2 interventions
Group C: Part 2a: Dose ExpansionExperimental treatment 1 intervention
Group D: Part 2b: Dose ExpansionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of participants with Dose Limiting Toxicities (DLT)s in Part 1
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Time frame
Up to 28 days2
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events AE (either reported for the first time or the worsening of a pre-existing event) occurring after the first dose of study drug and up to 60 days after last dose of study drug or until the start of a new disease-directed therapy, whichever occurs first.
Time frame
Up to approximately 2 years3
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with TEAEs leading to study drug modifications (interruptions, dose reduction) or discontinuation.
Time frame
Up to approximately 2 yearsSecondary outcomes
1
Pharmacokinetics Parameter: Cmax of INCA036978
Defined as maximum observed plasma concentration of INCA036978.
Time frame
Up to approximately 2 years2
Pharmacokinetics Parameter: Tmax of INCA036978
Defined as the time to reach the maximum plasma concentration of INCA036978.
Time frame
Up to approximately 2 years3
Pharmacokinetics Parameter: Cmax,ss of INCA036978
Defined as the maximum observed plasma concentration at steady state of INCA036978.
Time frame
Up to approximately 2 years4
Pharmacokinetics Parameter: Cmin,ss of INCA036978
Defined as the minimum observed plasma concentration at steady state of INCA036978.
Time frame
Up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov