Safety, Tolerability, and Pharmacokinetics of SHC014748M in Patients With Indolent B-Cell Hematologic Malignancies
NCT ID: NCT03588598
Last Updated: 2019-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
40 participants
INTERVENTIONAL
2018-09-07
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SHC014748M treatment
SHC014748M capsule， 50, 100, 150, 200, 250 mg, QD, 28 days for each cycle
SHC014748M
a selective PI3Kδ inhibitor
Interventions
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SHC014748M
a selective PI3Kδ inhibitor
Eligibility Criteria
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Inclusion Criteria
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
2. Had any other anti-tumor treatment within 4 weeks prior to screening (including radiotherapy, chemotherapy, hormone therapy, surgery or targeted therapy).
3. Evidence of central nervous system involvement of the malignancy.
4. Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, uncontrolled pleural effusion and ascites, uncontrolled diabetes, non-infectious pneumonia, and any other severe cardiovascular, respiratory, nervous and mental diseases.
5. Any of the severe heart diseases, including New York Heart Association (NYHA) Class II or greater heart failure, arrhythmias requiring medical treatment, and history of myocardial infarction or unstable angina within 6 months prior to screening.
6. Require any concomitant medication known to prolong the QT interval during the study.
7. Evidence of active bacterial, fungal, or viral infection.
8. Active infection with hepatitis B virus (HBV) (HBsAg positive, or HBsAg negative and HBV-DNA positive), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
9. Use of high-dose glucocorticoids (eg, ≥20 mg/day prednisone) or other immunosuppressants within 4 weeks prior to study entry.
10. Concomitant use of any strong inhibitors or inducers of CYP3A4.
11. Use of G-CSF or blood transfusion within 7 days before the hematology test at screening.
12. Prior autologous hematopoietic stem cell transplantation within 6 months prior to treatment initiation.
13. History of prior allogeneic hematopoietic stem cell transplantation.
14. Major surgery within 4 weeks prior to treatment initiation.
15. History of a non-lymphoma malignancy in the past five years except for the following: adequately treated cervical carcinoma in situ, local basal cell or squamous cell carcinoma of the skin.
16. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the drug or previous significant bowel resection that would preclude adequate absorption of the study drug.
17. History of hypersensitivity to drugs similar to the study drug or inactive excipients of the study drug.
18. Women who are breastfeeding.
18 Years
75 Years
ALL
No
Sponsors
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Nanjing Sanhome Pharmaceutical, Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jianyong Li, MD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Jie Jin, MD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital, Zhejiang University
Locations
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The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Jianyong Li, MD
Role: primary
Jie Jin, MD
Role: primary
Other Identifiers
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SHC014-I-01
Identifier Type: -
Identifier Source: org_study_id