A Phase II, Single Arm, Multicenter and Open Labelstudy Evaluating the Efficacy, Safety and Pharmacokinetics of HMPL-453 in Patient With Advanced Malignant Mesothelioma

Hutchison Medipharma Limited1 site in 1 country27 target enrollmentDecember 30, 2019

ConditionsAdvanced Malignant Mesothelioma

InterventionsHMPL-453

Overview

Phase: Phase 2
Intervention: HMPL-453
Conditions: Advanced Malignant Mesothelioma
Sponsor: Hutchison Medipharma Limited
Enrollment: 27
Locations: 1
Primary Endpoint: Overall response rate (ORR)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase II, single arm, multicenter and open-label study to evaluate the efficacy, safety and pharmacokinetic of HMPL-453 in patient with advanced Malignant Mesothelioma

Detailed Description

Histologically confirmed patients with advanced malignant mesothelioma that who was failure of the first -line systemic therapy

Registry

clinicaltrials.gov

Start Date

December 30, 2019

End Date

March 17, 2023

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hutchison Medipharma Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•1.Signed written informed consent;
•2.18 years of age or older;
•3.Histologically diagnosed malignant mesothelioma (including pleura, peritoneum, pericardium, and testicular tendon sheath origin, cell type epithelioid, sarcoma-like, or mixed type), and cannot be cured radically;
•4.Received one to three regimen of prior systemic therapy and then experienced documented radiographic progression or intolerable toxicity;
•5.Patients agreed to provide tumor tissue for FGF/FGFR testing;
•6.Measurable disease by RECIST version 1.1 criteria;
•7.ECOG performance status ≤ 2.;

Exclusion Criteria

•1.Previous treatment with any FGFR inhibitor;
•2.Received systemic anti-cancer therapy within 3 weeks of the first dose of HMPL-453;
•3.Major surgery within 4 weeks of the first dose of HMPL-453;
•4.Use of a strong inducer or inhibitor of cytochrome P450 3A4 (CYP3A4) within 1 week of the first dose of HMPL-453;
•5.Inadequate conditions as indicated by the following laboratory values:
•Absolute neutrophil count (ANC)\<1.5 x 109/L
•Hemoglobin \< 80 g/L
•Platelet count \<80 x 109/L
•6.Any of the following conditions of liver and kidney insufficiency:
•Total bilirubin \> 1.5 x ULN

Arms & Interventions

HMPL-453

Intervention: HMPL-453

Outcomes

Primary Outcomes

Overall response rate (ORR)

Time Frame: measured up to 6 months after the last subject has been enrolled or all subjects have finished their last PFS follow up, whichever comes first

Evaluating ORR of HMPL-453 in patient with advanced malignant mesothelioma

Secondary Outcomes

Disease control rate (DCR)(measured up to 6 months after the last subject has been enrolled or all subjects have finished their last PFS follow up, whichever comes first)
12 weeks DCR(measured on 12 weeks)
Time to Response (TTR)(measured on 4 weeks)
Duration of response (DoR)(measured on 30 weeks)
Overall survival (OS)(measured on 60weeks)
Maximum plasma concentration (Cmax) of HMPL-453(measured on Cycle 1 day 15 and day 16)
12 weeks PFS(measured on 12 weeks)
Progression free survival (PFS)(measured on 20 weeks)
Adverse Event (AE) of HMPL-453 monitoring(Measured from the first dose to within 30 days after the end of treatment.)
The time to Cmax (Tmax) of HMPL-453(measured on Cycle 1 day 15 and day 16)
The area under the plasma concentration-time curve (AUC) of HMPL-453(measured on Cycle 1 day 15 and day 16)