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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of SHC014748M in patients with relapsed or refractory indolent B-cell hematologic malignancies.
Full description
This is a phase I, sequential dose escalation followed by cohort expansion study of SHC014748M, an oral inhibitor of PI3K delta, in patients with relapsed or refractory indolent B-cell hematologic malignancies.
Enrollment
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Inclusion criteria
1.18- 75 years of age.
2.Histologically or cytologically confirmed diagnosis of relapsed or refractory indolent B-cell hematologic malignancies, including but not limited to CLL / SLL, FL (grade 1, 2 or 3a), or MZL.
3.Patients have received at least 1 prior regimen (at least 2 cycles).
4.Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
5.Life expectancy ≥ 3 months.
6.Patients have at least 1 measurable lesion that measures ≥1.5 cm in a single dimension as assessed by CT or MRI.
7.Adequate organ function, as defined by the following values: ANC≥1.0×10^9/L; PLT≥50×10^9/L; Hb≥80 g/L; TBIL≤1.5×ULN; ALT and AST≤2.5×ULN; BUN and Cr≤1.5×ULN; LVEF≥50%; QTcF <450 ms for male, QTcF <470 ms for female;
8.Men and women of childbearing potential are willing to employ an effective method of contraception for the entire duration of study and 6 months after the last dose, and female subjects of childbearing potential have a negative pregnancy test at baseline.
9.Subjects did not participate in other clinical trials within 3 months prior to study entry.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
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Central trial contact
Xiaodan Lyu; Wei Guo
Data sourced from clinicaltrials.gov
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