KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/3/2019 |
| Start Date: | January 15, 2019 |
| End Date: | October 2023 |
| Contact: | John Mei |
| Email: | jmei@kartosthera.com |
| Phone: | 6505420136 |
A Two-Part, Randomized, Open-label, Multicenter, Phase 2a/2b Study of the Efficacy, Safety, and Pharmacokinetics of KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the
treatment of patients with phlebotomy-dependent polycythemia vera (PV). Inhibition of MDM2 in
PV is a new mechanism of action in PV. In Part A, patients must be resistant or intolerant to
hydroxyurea or have undergone treatment with interferon. In Part B, patients must be
resistant or intolerant to hydroxyurea.
This study is a global, open-label Phase 2a/2b study to determine the efficacy and safety of
KRT-232. In Part A of the study, patients will be randomly assigned to 3 arms with 2
different doses and 2 different dosing schedules of KRT 232. In Part B of the study, patients
will be randomized either to treatment with KRT-232 administered at the recommended dose and
schedule from Part A or to treatment with ruxolitinib.
treatment of patients with phlebotomy-dependent polycythemia vera (PV). Inhibition of MDM2 in
PV is a new mechanism of action in PV. In Part A, patients must be resistant or intolerant to
hydroxyurea or have undergone treatment with interferon. In Part B, patients must be
resistant or intolerant to hydroxyurea.
This study is a global, open-label Phase 2a/2b study to determine the efficacy and safety of
KRT-232. In Part A of the study, patients will be randomly assigned to 3 arms with 2
different doses and 2 different dosing schedules of KRT 232. In Part B of the study, patients
will be randomized either to treatment with KRT-232 administered at the recommended dose and
schedule from Part A or to treatment with ruxolitinib.
Inclusion Criteria:
- Confirmed diagnosis of PV (WHO 2016)
- ECOG ≤ 2
- Part A: patients with and without splenomegaly are eligible
- Part A: patients must be resistant or intolerant to hydroxyurea or have undergone
treatment with interferon
- Part B: only patients with splenomegaly are eligible
- Part B: patients must be resistant or intolerant to hydroxyurea
Exclusion Criteria:
- Diagnosis of post-PV myelofibrosis (IWG-MRT)
- Prior treatment with MDM2 inhibitors, p53-directed therapies, HDAC, BCL 2 inhibitors
- Splenic irradiation within 3 months prior to the first dose of study treatment
- Clinically significant thrombosis within 3 months of screening
- Grade 2 or higher QTc prolongation
- Part B: prior treatment with a JAK inhibitor
We found this trial at
9
sites
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Phone: 503-346-0227
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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1801 West Taylor, Suite 1E
Chicago, Illinois 60612
Chicago, Illinois 60612
312.355.1625
Phone: 312-996-5931
University of Illinois Cancer Center The University of Illinois Cancer Center is dedicated to reducing...
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Hradec Králové,
Phone: 420 495 833 846
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Los Angeles, California 90033
Phone: 323-865-3000
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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