A Study of Hutchison MediPharma Limited(HMPL)-523 in Patients With Relapsed or Refractory Mature B-cell Neoplasms

NCT02857998 | Completed Phase 1

• 1 other identifier: 2015-523-00CH1
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 2

Brief Summary

A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HMPL-523 in Patients With Relapsed or Refractory Mature B-cell Neoplasms

Conditions

Mature B-cell Neoplasms

Outcome Measures

Primary Outcomes (1)

• Dose limited toxicities evaluated with NCI CTCAE v4.03

  Incidence of dose limited toxicities and associated dose of HMPL-523

  within 28 days after the first dose

Secondary Outcomes (4)

• Maximum plasma concentration calculated with Blood samples

  within 29 days after the first dose

• Time to reach maximum concentration calculated with Blood samples

  within 29 days after the first dose

• Objective response rate

  within 30 days after the last dose

• Adverse events evaluated by NCI CTCAE v4.03

  from the first dose to within 30 days after the last dose

Study Arms (1)

HMPL-523

EXPERIMENTAL

Oral administration, at dose of 200, 400, 600 and 800 mg once daily;at dose of 200,300, 400mg twice daily at Dose-escalation stage; At Dose-expansion stage, if patients dosing at 600mgQD.

Drug: HMPL-523

Interventions

HMPL-523 DRUG

Oral administration, once daily

Also known as: HMPL-523 Acetate

HMPL-523

Eligibility Criteria

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

You may qualify if:

• Signed Informed Consent Form
• Age \>=18 years
• Histologically relapsed or refractory mature B-cell Neoplasms, have failed at least one prior therapy or patients who are unable to tolerate standard therapy or no curative therapy or therapy of higher priority exists
• Eastern Cooperative Oncology Group（ECOG） performance status of 0 or 1
• Expected survival of more than 24 weeks as determined by the investigator
• In expansion stage, Subjects should have at least one dual diameter measurable lesion expect for subject with CLL or subject with LPL/WM with abonormal immunoglobulin

You may not qualify if:

• Patients with primary central nervous system(CNS) lymphoma
• Any of the following laboratory abnormalities:
• Absolute neutrophil count\<1.5×109/L
• Hemoglobin \<80g/L
• Platelet\<75 ×109 /L
• Inadequate organ function, defined by the following:
• Total bilirubin \>1.5the ULN with the following exception:
• Patients with known Gilbert disease who have serum bilirubin level ≤3 the upper limit of normal(ULN) and normal Aspartate aminotransferase(AST)/Alanine aminotransferase(ALT) may be enrolled.
• AST and/or ALT \> 2.5 the ULN with the following exception:Patients with documented disease infiltration of the liver may have AST and/or ALT levels ≤ 5 the ULN.
• Serum amylase or lipase \> the ULN
• Serum creatinine \> 1.5 the ULN or estimated creatinine clearance \< 50 mL/min
• International normalized ratio (INR)\>1.5 the ULN or activated partial thromboplastin time (aPTT)\>1.5 the ULN
• Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)
• Pregnant (positive pregnancy test) or lactating women
• New York Heart Association (NYHA) Class II or greater congestive heart failure

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (2)

BeijingCancer Hospital

Beijing, Beijing Municipality, China

Location

Fudan University Shanghai Cancer Hospital

Shanghai, 200032, China

Location

Related Publications (1)

• Song Y, Cao J, Zhang Q, Li C, Qiu L, Qi J, Zhang H, Li W, Liu L, Jing H, Zhou K, Zhang W, Zhang L, Li D, Zou L, Yang H, Qian W, Zhou H, Hu J, Yin H, Fu S, Fan S, Xu Q, Wang J, Jia X, Dai G, Su W, Zhu J. Phase I study of the Syk inhibitor sovleplenib in relapsed or refractory mature B-cell tumors. Haematologica. 2024 Jul 1;109(7):2165-2176. doi: 10.3324/haematol.2022.282401.

  PMID: 38235512 DERIVED

Study Officials

• Chen Yang, M.D.

  Hutchison Medipharma Ltd.

  STUDY CHAIR

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: August 3, 2016
• First Posted: August 5, 2016
• Study Start: December 27, 2016
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)