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Trial record 1 of 1 for:    NCT03136185
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IMG-7289 in Patients With Myelofibrosis

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ClinicalTrials.gov Identifier: NCT03136185
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Imago BioSciences,Inc.

Tracking Information
First Submitted Date  ICMJE April 18, 2017
First Posted Date  ICMJE May 2, 2017
Last Update Posted Date March 10, 2020
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
Incidence of treatment-emergent adverse events, and changes in physical examination, vital signs and laboratory parameters [safety and tolerability] [ Time Frame: Assessed from the time of first dose through 28 days after end of treatment. ]
as measured by the frequent monitoring of: adverse events, physical examination and vital signs and laboratory parameters.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2019)
  • Drug Concentration (performed in Phase 1/2a only) [ Time Frame: Up to 3 months. ]
    as measured by Cmin sampling.
  • Spleen Volume [ Time Frame: Baseline to each visit where the variable is measured. ]
    Reduction in spleen volume based on MRI (or CT)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
Drug Concentration [ Time Frame: Up to 3 months. ]
as measured by Cmin sampling.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IMG-7289 in Patients With Myelofibrosis
Official Title  ICMJE A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients With Myelofibrosis
Brief Summary

This is a Phase 2b open label study of an orally administered LSD1 inhibitor, IMG-7289, in patients with myelofibrosis.

This study investigates the following:

  • The safety and tolerability of IMG-7289
  • The pharmacokinetics of IMG-7289 (performed in Phase 1/2a only)
  • The pharmacodynamic effect of IMG-7289
Detailed Description With enrollment complete in Phase 1/2a, expansion into Phase 2b has occurred. New patients will be enrolled into Phase 2b study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Myelofibrosis
  • Post-polycythemia Vera Myelofibrosis (PPV-MF)
  • Post-essential Thrombocythemia Myelofibrosis (PET-MF)
  • Primary Myelofibrosis (PMF)
Intervention  ICMJE Drug: IMG-7289
Differentiation therapy
Other Name: LSD1 inhibitor
Study Arms  ICMJE Experimental: IMG-7289
Single starting dose with individualized dose titrations throughout
Intervention: Drug: IMG-7289
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 24, 2019)
50
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2017)
15
Estimated Study Completion Date  ICMJE February 1, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • >18 years
  • Diagnosis of either PMF per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms, PPV-MF or PET-MF per the IWG-MRT
  • High or intermediate-2 risk disease, as defined per protocol

Exclusion Criteria:

  • Receiving other treatments for the condition (with exceptions and time limits)
  • Major surgery in last 4 weeks, minor surgery in the last 2 weeks
  • History of, or scheduled, hematopoietic stem cell transplant within 24 weeks of Screening
  • History of splenectomy
  • Current use of prohibited medications
  • A concurrent second active and nonstable malignancy
  • Known HIV infection or active Hepatitis B or Hepatitis C virus infection
  • Other hematologic/biochemistry requirements, as per protocol
  • Use of investigational agent within last 14 days
  • Pregnant or lactating females
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Peppe +1-415-529-5055 jennifer.peppe@imagobio.com
Contact: Amber Jones amber.jones@imagobio.com
Listed Location Countries  ICMJE Australia,   Germany,   Italy,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03136185
Other Study ID Numbers  ICMJE IMG-7289-CTP-102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Imago BioSciences,Inc.
Study Sponsor  ICMJE Imago BioSciences,Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kristen Pettit University of Michigan
PRS Account Imago BioSciences,Inc.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP