Back to resultsA Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies
Primary Purpose
Relapsed or Refractory B-cell Hematologic Malignancies
Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HEC89736
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed or Refractory B-cell Hematologic Malignancies
Eligibility Criteria
Inclusion Criteria:
- Age is over 18 years old
- Histologically or cytologically diagnosed patients with recurrent or refractory B-cell malignancies
- ECOG performance status (PS) 0 ~ 1
- Expected survival of > or = 3 months
Exclusion Criteria:
- The use of PI3Ks as the target of anti-tumor drugs progress (due to intolerance group)
- Received any other anti-cancer treatment within 4 weeks
- Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug use and absorption
- Allergy, or known to have a history of allergy to the drug components
Sites / Locations
- Beijing Cancer Hospital
- Jiangsu Province Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HEC89736 treatment
Arm Description
HEC89736 tablets,25 mg, 50 mg, 100 mg, 150 mg, 200 mg, QD, 28 days for each cycle
Outcomes
Primary Outcome Measures
Dose limited toxicities evaluated with NCI-CTC AE v5.0 after the first dose
Incidence of dose limited toxicities and associated dose of HEC89736
Adverse events evaluated by NCI CTCAE 5.0
Incidence of adverse events and associated dose of HEC89736
Secondary Outcome Measures
Full Information
NCT ID
NCT04865458
First Posted
April 26, 2021
Last Updated
May 5, 2022
Sponsor
Sunshine Lake Pharma Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04865458
Brief Title
A Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies
Official Title
A Phase I Single Arm,Open-label,Multiple Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Lake Pharma Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the safety, pharmacokinetics and efficacy of HEC89736 in patients with Relapsed or Refractory B-cell Hematologic Malignancies
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory B-cell Hematologic Malignancies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HEC89736 treatment
Arm Type
Experimental
Arm Description
HEC89736 tablets,25 mg, 50 mg, 100 mg, 150 mg, 200 mg, QD, 28 days for each cycle
Intervention Type
Drug
Intervention Name(s)
HEC89736
Intervention Description
HEC89736 tablets QD every 28 days for each cycle
Primary Outcome Measure Information:
Title
Dose limited toxicities evaluated with NCI-CTC AE v5.0 after the first dose
Description
Incidence of dose limited toxicities and associated dose of HEC89736
Time Frame
Dosing started until the 28th day
Title
Adverse events evaluated by NCI CTCAE 5.0
Description
Incidence of adverse events and associated dose of HEC89736
Time Frame
From the frst dose to within 30 days after the last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age is over 18 years old
Histologically or cytologically diagnosed patients with recurrent or refractory B-cell malignancies
ECOG performance status (PS) 0 ~ 1
Expected survival of > or = 3 months
Exclusion Criteria:
The use of PI3Ks as the target of anti-tumor drugs progress (due to intolerance group)
Received any other anti-cancer treatment within 4 weeks
Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug use and absorption
Allergy, or known to have a history of allergy to the drug components
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Jianyong, Doctor
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Song Yuqing, Doctor
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies
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