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Safety, Tolerability, and Pharmacokinetics of SHC014748M in Patients With Indolent B-Cell Hematologic Malignancies

NCT03588598 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)
  • B-Cell Non-Hodgkin Lymphomas(NHL)

Interventions

DRUG

SHC014748M

a selective PI3Kδ inhibitor

Sponsors & Collaborators

  • Nanjing Sanhome Pharmaceutical, Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jianyong Li, MD · The First Affiliated Hospital with Nanjing Medical University

  • Jie Jin, MD · The First Affiliated Hospital, Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-07
Primary Completion
2019-07-31
Completion
2019-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03588598 on ClinicalTrials.gov