NCT04865458

Brief Summary

Evaluate the safety, pharmacokinetics and efficacy of HEC89736 in patients with Relapsed or Refractory B-cell Hematologic Malignancies

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2021

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

April 26, 2021

Last Update Submit

May 5, 2022

Conditions

Relapsed or Refractory B-cell Hematologic Malignancies

Outcome Measures

Primary Outcomes (2)

  • Dose limited toxicities evaluated with NCI-CTC AE v5.0 after the first dose

    Incidence of dose limited toxicities and associated dose of HEC89736

    Dosing started until the 28th day

  • Adverse events evaluated by NCI CTCAE 5.0

    Incidence of adverse events and associated dose of HEC89736

    From the frst dose to within 30 days after the last dose

Study Arms (1)

HEC89736 treatment

EXPERIMENTAL

HEC89736 tablets,25 mg, 50 mg, 100 mg, 150 mg, 200 mg, QD, 28 days for each cycle

Drug: HEC89736

Interventions

HEC89736DRUG

HEC89736 tablets QD every 28 days for each cycle

HEC89736 treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Li Jianyong, Doctor

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

  • Song Yuqing, Doctor

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2021

First Posted

April 29, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2023

Study Completion

April 1, 2024

Last Updated

May 6, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)