A Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies

NCT ID: NCT04865458

Last Updated: 2022-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2024-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Relapsed or Refractory B-cell Hematologic Malignancies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HEC89736 treatment

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

Group Type EXPERIMENTAL

HEC89736

Intervention Type DRUG

HEC89736 tablets QD every 28 days for each cycle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HEC89736

HEC89736 tablets QD every 28 days for each cycle

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Li Jianyong, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Song Yuqing, Doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HEC89736-P-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of YK012 in B-cell Acute Lymphoblastic Leukemia
NCT06580301 RECRUITING PHASE1/PHASE2