Study of Oral SKI-O-703, SYK Inhibitor, in Patients With Persistent and Chronic Immune Thrombocyt… (NCT04056195) | Clinical Trial Compass
CompletedPhase 2
Study of Oral SKI-O-703, SYK Inhibitor, in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP)
United States, Greece61 participantsStarted 2019-10-11
Plain-language summary
Study in patients with persistent and chronic Immune Thrombocytopenia (ITP), who have failed to respond or relapsed after prior therapy, with a platelet count \<30,000/µL. Patient will be randomly assigned in 2 groups with two dose levels of SKI-O-703 200mg BID, 400 mg BID, and placebo; administered orally twice a day.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Diagnosis of primary ITP (persistent or chronic)
* Failed to respond or relapsed after at least 1 prior therapy, with a platelet count of \<30,000/µL on 2 occasions at least 7 days apart with the confirmatory count on the first day of treatment
* Adequate hematologic, hepatic, and renal function
* ECOG performance status of 0, 1, or 2
* Male and female subjects, the subject and their partners of childbearing potential agree to use medically acceptable methods of contraception during the study and for 6 months following discontinuation of study drug (excluding women who are not of childbearing potential and men who have been sterilized. Men who have been sterilized should be confirmed to have negative sperm count on 2 consecutive occasions.)
* Male subjects agree not to donate sperm for 90 days after the last dose of study drug
* Female subjects have negative pregnancy tests at Screening.
Exclusion Criteria:
* History of current, active malignancy requiring or likely to require chemotherapeutic or surgical treatment during the study, with the exception of non-melanoma skin cancer, carcinoma in situ of the cervix, and localized prostate cancer managed by active surveillance
* Transfusion with blood or blood products or plasmapheresis within 2 weeks before the first administration of study drug
* History of known inherited coagulopathy, or recent arterial or deep venous thrombosis within the preceding 6 months
* Change in corticosteroid or immunosuppress…