A Phase 2,Multi-center, Open-label Study Evaluating Safety and Efficacy of Jaktinib Hydrochloride Tablets in Intermediate-risk and High-risk Myelofibrosis.

Suzhou Zelgen Biopharmaceuticals Co.,Ltd1 site in 1 country118 target enrollmentJanuary 8, 2019

ConditionsMyelofibrosis

InterventionsJaktinib hydrochloride tablets

Overview

Phase: Phase 2
Intervention: Jaktinib hydrochloride tablets
Conditions: Myelofibrosis
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Enrollment: 118
Locations: 1
Primary Endpoint: effective rate
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This was an open-label, multi-center, randomized phase 2 study. This is a two-stage design.In the first stage, two dose groups were set up, the 100 mg bid dose group and the 200 mg qd dose group, which were randomized at 1:1, with 50 subjects in each group, and a total of 100 cases in the two groups. In the second stage, approximately 36 subjects were added to the randomized group.

Detailed Description

According to the results of the interim analysis of the ZGJAK002 of Jaktinib, a comprehensive evaluation of the benefits and risks of subjects in the 100mg bid and 200mg qd groups, the investigator and the sponsor decided to expand the enrollment of approximately 36 subjects taking 100mg bid.

Registry

clinicaltrials.gov

Start Date

January 8, 2019

End Date

February 2, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Any significant clinical or laboratory abnormalities that the investigator considers to affect safety assessment, such as: a. uncontrolled diabetes (\> 250 mg/dL, or 13.9 mmol \> / L), b. had high blood pressure and antihypertensive drug treatment under two or unable to descend to the ranges (systolic blood pressure \< 160 mmHg, diastolic pressure \< 100 mmHg), c. peripheral neuropathy (NCI - CTC AE v4.03 standard grade 2 or above), d. thyroid dysfunction (\> NCI - CTC AE v4.03 standard grade 2 or above);
•The patients had a history of congestive heart failure, uncontrollable or unstable angina or myocardial infarction, cerebrovascular accident or pulmonary embolism in the first 6 months;
•Screening of patients who have not fully recovered from surgery within the first 4 weeks;
•Screening for patients with arrhythmia requiring treatment or QTc interval (QTcB) \>480ms;
•Screening for bacterial, viral, parasitic or fungal infections with any clinical symptoms that require treatment;
•Patients with a history of congenital or acquired hemorrhagic diseases;
•Patients who had previously undergone splenectomy or who had received radiotherapy of the splenic region within the first 12 months of screening;
•Screening for HIV positive, active hepatitis b virus positive (HBsAg positive, hbv- dna positive or greater than 1000 copies /ml), anti-hcv antibody or hcv-rna positive;
•Patients suffering from epilepsy or using psychotropic or sedative drugs at the time of screening;
•Women who are planning to become pregnant or who are pregnant or breast- feeding, as well as those who were unable to use effective contraceptives throughout the trial;Male patients who do not use condoms during the administration and within 2 days (approximately 5 half-lives) after the last administration;