Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

Summary

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.

Official Title

A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms

Keywords

Myeloproliferative Neoplasms, Myelofibrosis, Essential thrombocythemia, Polycythemia Vera, Myeloproliferative Disorders, Primary Myelofibrosis, INCA036978

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.
  • Has undergone any prior allogeneic stem-cell transplantation or such transplantation is planned in the next 6 months.
  • Laboratory values outside the Protocol-defined ranges.
  • Prior history of major bleeding or thrombosis within the last 3 months prior to study enrollment.
  • Presence of chronic or current active infectious disease requiring systemic treatment.
  • Treatment with an MPN-directed therapy (approved or investigational) within the per protocol threshold before the administration of study drug.
  • Prior radiation therapy within 28 days before the first dose of study treatment.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Locations

  • UCLA Medical Hematology & Oncology not yet accepting patients
    Los Angeles California 90095 United States
  • City of Hope-Lennar Foundation Cancer Center not yet accepting patients
    Irvine California 92618 United States
  • Usc Norris Comprehensive Cancer Center not yet accepting patients
    Los Angeles California 90033 United States
  • Icon Cancer Centre accepting new patients
    Auchenflower Queensland 04066 Australia
  • Epworth Health Care accepting new patients
    East Melbourne Victoria 03002 Australia
  • Linear Clinical Research not yet accepting patients
    Nedlands Western Australia 06009 Australia

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
Links
Study of INCA036978 in Participants With Myeloproliferative Neoplasms
ID
NCT07441694
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 218 study participants
Last Updated