Myeloproliferative neoplasms (MPN)

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

Incyte Study ID:

INCA 33989-101

CT.gov ID:

NCT05936359

Eudra ID:

N/A

Sponsor:

Incyte Corporation

Collaborator:

N/A

Study Contact Information:

1.855.463.3463 or [email protected]

Recruiting

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Clinical Study Purpose

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.

Clinical Study Summary

MEDICAL CONDITION(S)

Myeloproliferative neoplasms (MPN)

PRODUCT

Drug: INCA033989

Drug: Ruxolitinib

COLLABORATORS

N/A

DATE

Sep 2023 - Feb 2028

TYPE

Interventional

PHASE

Phase 1

SEX

Female & Male

AGE

18+ years

ACCEPTS HEALTHY VOLUNTEERS

Key Inclusion and Exclusion Criteria

Inclusion Criteria

Life expectancy > 6 months.
Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).

Exclusion Criteria

Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
Active invasive malignancy over the previous 2 years.

Clinical Study Locations

Location

Status

Location

ROYAL ADELAIDE HOSPITAL

ADELAIDE, SA, Australia, 05000

Status

Recruiting

Location

ROYAL BRISBANE AND WOMEN'S HOSPITAL

HERSTON, QLD, Australia, 04029

Status

Recruiting

Location

THE ALFRED HOSPITAL

MELBOURNE, VIC, Australia, 03004

Status

Recruiting

Location

PETER MACCALLUM CANCER CENTRE

MELBOURNE, VIC, Australia, 03000

Status

Recruiting

Location

PRINCESS MARGARET CANCER CENTER

TORONTO, ON, Canada, M5G 2M9

Status

Recruiting

Location

HOPITAL MAISONNEUVE-ROSEMONT, MONTREAL, QC

MONTREAL, QC, Canada, QC H1T 2M4

Status

Recruiting

Protocol Summary

Incyte Study ID:

INCA 33989-101

Primary Purpose:

Treatment

Allocation:

Non-randomized

Study Design:

Sequential Assignment

Masking:

None (Open Label)

Interventions:

Drug

Enrollment:

225

Primary Outcome

Open