A Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies
- Registration Number
- NCT04865458
- Lead Sponsor
- Sunshine Lake Pharma Co., Ltd.
- Brief Summary
Evaluate the safety, pharmacokinetics and efficacy of HEC89736 in patients with Relapsed or Refractory B-cell Hematologic Malignancies
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HEC89736 treatment HEC89736 HEC89736 tablets,25 mg, 50 mg, 100 mg, 150 mg, 200 mg, QD, 28 days for each cycle
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China