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

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

Treatments tested in this trial

  • INCA033989
  • Ruxolitinib

Treatment groups

225 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Locations

29
Australia
Royal Brisbane and Women'S Hospital04029, HerstonQueensland, Australia
Royal Adelaide Hospital05000, AdelaideSouth Australia, Australia
Peter Maccallum Cancer Centre03000, MelbourneVictoria, Australia
The Alfred Hospital03004, MelbourneVictoria, Australia

Sponsors and collaborators

Incyte Corporation

Lead sponsor