RECRUITING

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

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Conditions

Myeloproliferative NeoplasmsMyelofibrosisEssential thrombocythemiaCALR mutation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is being conducted to evaluate the safety, tolerability, 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.

Official Title

A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

Quick Facts

Study Start:2023-12-04
Study Completion:2028-10-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06034002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Life expectancy \> 6 months.
  2. * Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).
  3. * Existing documentation from a qualified local laboratory of CALR exon-9 mutation.
  4. * Participants with MF or ET as defined in the protocol.
  1. * Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
  2. * Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.
  3. * Participants with laboratory values exceeding the protocol defined thresholds.
  4. * Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.
  5. * Active invasive malignancy over the previous 2 years.
  6. * History of clinically significant or uncontrolled cardiac disease.
  7. * Active HBV/HCV or known history of HIV.
  8. * Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease, with the exception of ruxolitinib for TGBs only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
  9. * Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment.

Contacts and Locations

Study Contact

Incyte Corporation Call Center (US)
CONTACT
1.855.463.3463
medinfo@incyte.com
Incyte Corporation Call Center (ex-US)
CONTACT
+800 00027423
eumedinfo@incyte.com

Principal Investigator

Incyte Medical Monitor
STUDY_DIRECTOR
Incyte Corporation

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States
Stanford Cancer Institute
Palo Alto, California, 94304
United States
University of Miami Health System
Miami, Florida, 33136
United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Washington University School of Medicine
Saint Louis, Missouri, 63108
United States
Icahn School of Medicine At Mount Sinai
New York, New York, 10029
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Md Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Incyte Corporation

  • Incyte Medical Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-04
Study Completion Date2028-10-29

Study Record Updates

Study Start Date2023-12-04
Study Completion Date2028-10-29

Terms related to this study

Keywords Provided by Researchers

  • Myeloproliferative Neoplasms
  • Myelofibrosis
  • Essential thrombocythemia
  • CALR mutation

Additional Relevant MeSH Terms

  • Myeloproliferative Neoplasms