Relapsed or Refractory B-cell Hematologic Malignancies
Conditions
Brief summary
Evaluate the safety, pharmacokinetics and efficacy of HEC89736 in patients with Relapsed or Refractory B-cell Hematologic Malignancies
Interventions
DRUGHEC89736
HEC89736 tablets QD every 28 days for each cycle
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limited toxicities evaluated with NCI-CTC AE v5.0 after the first dose | Dosing started until the 28th day | Incidence of dose limited toxicities and associated dose of HEC89736 |
| Adverse events evaluated by NCI CTCAE 5.0 | From the frst dose to within 30 days after the last dose | Incidence of adverse events and associated dose of HEC89736 |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORLi Jianyong, Doctor
The First Affiliated Hospital with Nanjing Medical University
PRINCIPAL_INVESTIGATORSong Yuqing, Doctor
Peking University Cancer Hospital & Institute
Outcome results
None listed