A Study to Evaluate Safety, Pharmacokinetic, and Biological Activity of INCB059872 in Subjects With Sickle Cell Disease
Status: | Terminated |
---|---|
Conditions: | Anemia |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/3/2019 |
Start Date: | April 27, 2017 |
End Date: | September 17, 2018 |
A Phase 1 Open-Label, Dose-Escalation Study to Evaluate Safety, Pharmacokinetic, and Biological Activity of INCB059872 in Subjects With Sickle Cell Disease
The purpose of this study is to evaluate the safety and tolerability, and the pharmacokinetic
and biologic activity of INCB059872 in participants with sickle cell disease.
and biologic activity of INCB059872 in participants with sickle cell disease.
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.
We found this trial at
7
sites
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Boston University Boston University is no small operation . With over 33,000 undergraduate and graduate...
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University of Illinois at Chicago A major research university in the heart of one of...
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