Tolerance and Pharmacokinetics of SHR1459 in Patients With Recurrent Replased/Refractory Mature B Cell Neoplasmstumor

NCT03664297 | Unknown Phase 1

• 1 other identifier: SHR1459-I-101
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

SHR1459 is a selective small molecule BTK inhibitor developed by Jiangsu Hengrui medicine Limited, by inhibiting the phosphorylation of BTK and down regulation of BCR signal transduction pathway, And then selectively inhibit the proliferation and migration of B cell tumor.

Conditions

Mature B Cell Neoplasms

Keywords

replased/refractory mature B cell neoplasms; BTK inhibitor

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability])

  The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of SHR1459 will be assessed

  through study completion, an average of about 6 months

• Recommended phase 2 dose (RP2D)

  Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) will be established according to the incidence of dose-limiting toxicities (DLTs) of escalated doses of SHR1459

  28 days since the date of first dose

Secondary Outcomes (17)

• Objective response rate (ORR)

  every 8 weeks through study completion, an average of about 6 months

• Duration of Response (DoR)

  every 8 weeks through study completion, an average of about 6 months

• Progression-free survival (PFS)

  every 8 weeks through study completion, an average of about 6 months

• Time to Response (TTR)

  every 8 weeks through study completion, an average of about 6 months

• Time to peak (Tmax)

  Day 1 and Day 2 of the single dose

Study Arms (1)

SHR1459

EXPERIMENTAL

Oral administration, once a day, 28 days for a cycle, until the disease progression or the intolerable toxicity occurs.

Drug: SHR1459

Interventions

SHR1459 DRUG

SHR1459 will be administered continually till disease progression or unacceptable toxicity.

Also known as: No other intervention

SHR1459

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG Performance Status \[PS\] score must be 0 or 1;
• Life expectancy ≥ 12 weeks;
• Mature B cell eoplasmss with histological or cytological diagnosis, including diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL) , chronic lymphocytic leukemia/Small lymphocytic lymphoma (CLL/SLL), Mantle cell lymphoma (MCL), Marginal zone lymphoma (MZL) and waldenstrom macroglobulinemia (WM);
• The function of bone marrow is basically normal;
• Renal function is basically normal;
• Hepatic function is basically normal.

You may not qualify if:

• Had received treatment with the compound of the same mechanism (BTK inhibitor);
• With infiltration of lymphoma central nervous system;
• Received autologous stem cell transplantation within 60 days before signing the informed consent, received allogeneic stem cell transplantation in 90 days (after allogeneic stem cell transplantation, if graft-versus-host disease appeared, it must be ≤ level 1, and if there was no prohibited medication, the screening could be performed);

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Blood disease hospital of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300000, China

Location

Study Officials

• Lugui Qiu

  Blood Institute of the Chinese Academy of Medical Sciences

  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: September 6, 2018
• First Posted: September 10, 2018
• Study Start: February 6, 2018
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)