search
Back to results

HMPL-453 in Advanced Malignant Mesothelioma

Primary Purpose

Advanced Malignant Mesothelioma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HMPL-453
Sponsored by
Hutchison Medipharma Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Malignant Mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
    • AST and ALT > 2.5 x ULN (> 5 x ULN for patients with liver metastases)
    • Creatinine clearance of < 50 mL/min as estimated by the Cockcroft-Gault equation
  • 7.International normalized ratio (INR) >1.5 or activated partial thromboplastin time (aPTT) >1.5 x ULN;
  • 8.Clinical significant liver disease;
  • 9.Known human immunodeficiency virus (HIV) infection
  • 10.Previous history of retinal detachment;
  • 11.Unable to swallow the study drug.

Sites / Locations

  • Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HMPL-453

Arm Description

HMPL-453

Outcomes

Primary Outcome Measures

Overall response rate (ORR)
Evaluating ORR of HMPL-453 in patient with advanced malignant mesothelioma

Secondary Outcome Measures

Disease control rate (DCR)
Evaluating DCR of HMPL-453 in patient with advanced malignant mesothelioma
12 weeks DCR
Evaluating 12 weeks DCR of HMPL-453 in patient with advanced malignant mesothelioma
Time to Response (TTR)
Evaluating TTR of HMPL-453 in patient who achieved partial response or complete response according to RECIST 1.1 or mRECIST 1.1
Duration of response (DoR)
Evaluating DoR of HMPL-453 in patient from subject first achieve a complete remission, or partial remission to patient PD, or death whichever comes first.
12 weeks PFS
Evaluating 12 weeks PFS rate of HMPL-453 in patient with advanced malignant mesothelioma
Progression free survival (PFS)
Evaluating PFS of HMPL-453 in patient with advanced malignant mesothelioma.
Overall survival (OS)
Evaluating OS of HMPL-453 in patient with advanced malignant mesothelioma
Adverse Event (AE) of HMPL-453 monitoring
The safety endpoints include adverse events (AEs) and serious adverse events (SAEs). Reporting of safety, extent of exposure, concomitant medications and discontinuation of study therapy will be based on all subjects who received at least 1 dose of treatment. The adverse events will be registered according to NCI CTCAE 5.0.
Maximum plasma concentration (Cmax) of HMPL-453
Evaluating Cmax of Continuous dosing of HMPL-453 in patient with advanced malignant
The time to Cmax (Tmax) of HMPL-453
Evaluating Tmax of Continuous dosing of HMPL-453 in patient with advanced malignant
The area under the plasma concentration-time curve (AUC) of HMPL-453
Evaluating AUC from 0 to the time of the last measurable concentration of HMPL-453 in patient with advanced malignant

Full Information

First Posted
January 17, 2020
Last Updated
June 12, 2020
Sponsor
Hutchison Medipharma Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT04290325
Brief Title
HMPL-453 in Advanced Malignant Mesothelioma
Official Title
A Phase II, Single Arm, Multicenter and Open Labelstudy Evaluating the Efficacy, Safety and Pharmacokinetics of HMPL-453 in Patient With Advanced Malignant Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 30, 2019 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
March 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hutchison Medipharma Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Malignant Mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HMPL-453
Arm Type
Experimental
Arm Description
HMPL-453
Intervention Type
Drug
Intervention Name(s)
HMPL-453
Intervention Description
HMPL-453 tablet
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
Evaluating ORR of HMPL-453 in patient with advanced malignant mesothelioma
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
Secondary Outcome Measure Information:
Title
Disease control rate (DCR)
Description
Evaluating DCR of HMPL-453 in patient with advanced malignant mesothelioma
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
Title
12 weeks DCR
Description
Evaluating 12 weeks DCR of HMPL-453 in patient with advanced malignant mesothelioma
Time Frame
measured on 12 weeks
Title
Time to Response (TTR)
Description
Evaluating TTR of HMPL-453 in patient who achieved partial response or complete response according to RECIST 1.1 or mRECIST 1.1
Time Frame
measured on 4 weeks
Title
Duration of response (DoR)
Description
Evaluating DoR of HMPL-453 in patient from subject first achieve a complete remission, or partial remission to patient PD, or death whichever comes first.
Time Frame
measured on 30 weeks
Title
12 weeks PFS
Description
Evaluating 12 weeks PFS rate of HMPL-453 in patient with advanced malignant mesothelioma
Time Frame
measured on 12 weeks
Title
Progression free survival (PFS)
Description
Evaluating PFS of HMPL-453 in patient with advanced malignant mesothelioma.
Time Frame
measured on 20 weeks
Title
Overall survival (OS)
Description
Evaluating OS of HMPL-453 in patient with advanced malignant mesothelioma
Time Frame
measured on 60weeks
Title
Adverse Event (AE) of HMPL-453 monitoring
Description
The safety endpoints include adverse events (AEs) and serious adverse events (SAEs). Reporting of safety, extent of exposure, concomitant medications and discontinuation of study therapy will be based on all subjects who received at least 1 dose of treatment. The adverse events will be registered according to NCI CTCAE 5.0.
Time Frame
Measured from the first dose to within 30 days after the end of treatment.
Title
Maximum plasma concentration (Cmax) of HMPL-453
Description
Evaluating Cmax of Continuous dosing of HMPL-453 in patient with advanced malignant
Time Frame
measured on Cycle 1 day 15 and day 16
Title
The time to Cmax (Tmax) of HMPL-453
Description
Evaluating Tmax of Continuous dosing of HMPL-453 in patient with advanced malignant
Time Frame
measured on Cycle 1 day 15 and day 16
Title
The area under the plasma concentration-time curve (AUC) of HMPL-453
Description
Evaluating AUC from 0 to the time of the last measurable concentration of HMPL-453 in patient with advanced malignant
Time Frame
measured on Cycle 1 day 15 and day 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 AST and ALT > 2.5 x ULN (> 5 x ULN for patients with liver metastases) Creatinine clearance of < 50 mL/min as estimated by the Cockcroft-Gault equation 7.International normalized ratio (INR) >1.5 or activated partial thromboplastin time (aPTT) >1.5 x ULN; 8.Clinical significant liver disease; 9.Known human immunodeficiency virus (HIV) infection 10.Previous history of retinal detachment; 11.Unable to swallow the study drug.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenjuan Ding
Phone
+8602120671806
Ext
+8602120671806
Email
Wenjuand@hmplglobal.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Yu
Ext
+8602120673226
Email
Cheny@hmplglobal.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shun Lu, Prof.
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
ZIP/Postal Code
21000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shun Lu, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

HMPL-453 in Advanced Malignant Mesothelioma

We'll reach out to this number within 24 hrs