Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate Safety, Pharmacokinetic, and Biological Activity of INCB059872 in Subjects With Sickle Cell Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03132324
Recruitment Status : Terminated (This study is terminated due to a business decision not to pursue INCB059782 in Sickle Cell Disease indication.)
First Posted : April 27, 2017
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE April 24, 2017
First Posted Date  ICMJE April 27, 2017
Last Update Posted Date October 28, 2019
Actual Study Start Date  ICMJE April 20, 2017
Actual Primary Completion Date October 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
  • Safety and tolerability of INCB059872 assessed by monitoring frequency, duration, and severity of adverse events [ Time Frame: Screening through 35 days after end of treatment, up to approximately 3 months per participant. ]
    An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent.
  • Change in fetal hemoglobin (HbF) from baseline [ Time Frame: Baseline through 2 weeks after end of treatment, up to approximately 2.5 months per participant. ]
    Pharmacodynamic activity assessed by measuring changes of HbF from baseline and their correlation to INCB059872 treatment. The HbF (F cells) in human whole blood will be characterized using flow cytometry.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
  • Cmax of INCB059872 [ Time Frame: Baseline to Day 28. ]
    Defined as maximum observed plasma concentration.
  • AUC0-t of INCB059872 [ Time Frame: Baseline to Day 28. ]
    Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Safety, Pharmacokinetic, and Biological Activity of INCB059872 in Subjects With Sickle Cell Disease
Official Title  ICMJE A Phase 1 Open-Label, Dose-Escalation Study to Evaluate Safety, Pharmacokinetic, and Biological Activity of INCB059872 in Subjects With Sickle Cell Disease
Brief Summary The purpose of this study was to evaluate the safety and tolerability, and the pharmacokinetic and biologic activity of INCB059872 in participants with sickle cell disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE Drug: INCB059872
INCB059872 tablets
Study Arms  ICMJE
  • Experimental: INCB059872 0.5 mg
    INCB059872 0.5 mg tablet administered orally every other day (QOD) for 28 days on an empty stomach. If dose was well tolerated, once daily (QD) administration was evaluated independently and in parallel with QOD administration.
    Intervention: Drug: INCB059872
  • Experimental: INCB059872 1 mg
    INCB059872 1 mg tablet administered orally QOD for 28 days on an empty stomach. If dose was well tolerated, QD administration was evaluated independently and in parallel with QOD administration.
    Intervention: Drug: INCB059872
  • Experimental: INCB059872 2 mg
    INCB059872 2 mg tablet administered orally QOD for 28 days on an empty stomach. If dose was well tolerated, QD administration was evaluated independently and in parallel with QOD administration.
    Intervention: Drug: INCB059872
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 Terminated
Actual Enrollment  ICMJE
 (submitted: October 24, 2019)
12
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2017)
30
Actual Study Completion Date  ICMJE October 3, 2018
Actual Primary Completion Date October 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of SCD (sickle cell SS) confirmed through hemoglobin electrophoresis.
  • Must be red blood cell (RBC) transfusion-independent (not currently on regularly scheduled transfusions) for ≥ 3 months from the time of first dose of study drug.
  • No RBC transfusion within 30 days of first dose of study drug.
  • Hydroxyurea (HU) refractory

    -Must not have received HU therapy during the 3 months before receiving study drug.

  • Creatinine clearance ≥ 60 mL/min based on the institutional formula.
  • Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

  • Any unresolved toxicity ≥ Grade 2 from previous therapy except for stable chronic toxicities not expected to resolve.
  • Pregnant or nursing women or participants expecting to conceive or father children within the projected duration of the study, starting with screening visit through completion of safety follow-up.
  • Received an investigational study drug within 28 days or 5 half-lives (whichever is longer) before receiving the first dose of study drug (requirement may be waived with medical monitor approval).
  • Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
  • Prior receipt of LSD1 inhibitor therapy for any indication.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03132324
Other Study ID Numbers  ICMJE INCB 59872-102
Has Data Monitoring Committee No
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 Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Fitzroy Dawkins, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date October 2019

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