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A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

ConditionMyeloproliferative Neoplasms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIncyte Corporation

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • INCA033989

    Drug

    INCA033989 will be administered at protocol defined dose.

  • Ruxolitinib

    Drug

    Rux will be administered according to Prescribing Information/SmPC.

Treatment groups

225 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Part 1a Dose Escalation Cohort Disease Group A - with MFExperimental treatment 1 intervention
Group B: Part 1a Dose Escalation Cohort Disease Group A - with ETExperimental treatment 1 intervention
Group C: Part 1a: Dose Escalation Cohort Disease Group B - with TGB-MF SubOpt RExperimental treatment 2 interventions
Group D: Part 1b: Dose Expansion - with MFExperimental treatment 1 intervention
Group E: Part 1b: Dose Expansion - with TGB-MF SubOpt RExperimental treatment 2 interventions
Group F: Part 1b: Dose Expansion - with ETExperimental treatment 1 intervention
Group G: Part 1c: Dose ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of participants with Dose Limiting Toxicities (DLTs)

Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.

Time frame
Up to 28 days
2

Number of participants with Treatment-emergent Adverse Events (TEAEs)

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

Time frame
Up to 3 years and 60 days
3

Number of participants with TEAEs leading to dose modification or discontinuation

Number of participants with TEAEs leading to dose modification or discontinuation.

Time frame
Up to 3 years and 60 days

Secondary outcomes

1

Participants with MF: Response using the revised IWG-MRT and ELN response criteria for MF

Defined as the percentage of participants with Response using the revised IWG-MRT and ELN response criteria.

Time frame
Up to 3 years and 60 days
2

Participants With MF: Percentage of participants achieving spleen volume reduction as defined in the protocol

Defined as percentage of participants with a protocol defined Spleen Volume Reduction.

Time frame
Up to 3 years and 60 days
3

Participants with MF with symptomatic anemia: Anemia Response

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.

Time frame
Up to 3 years and 60 days
4

Participants With ET: Response Rate

Defined as the proportion of participants with Complete Response or Partial Response when treated with study drug.

Time frame
Up to 3 years and 60 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Incyte Corporation

Lead sponsor

Source ClinicalTrials.gov
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