HMPL-453 in Advanced Malignant Mesothelioma

June 12, 2020 updated by: Hutchison Medipharma Limited

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 21000
        • Recruiting
        • Shanghai Chest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HMPL-453
Drug: HMPL-453
HMPL-453 tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
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 DCR of HMPL-453 in patient with advanced malignant mesothelioma
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
Time Frame: measured on 12 weeks
Evaluating 12 weeks DCR of HMPL-453 in patient with advanced malignant mesothelioma
measured on 12 weeks
Time to Response (TTR)
Time Frame: measured on 4 weeks
Evaluating TTR of HMPL-453 in patient who achieved partial response or complete response according to RECIST 1.1 or mRECIST 1.1
measured on 4 weeks
Duration of response (DoR)
Time Frame: measured on 30 weeks
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.
measured on 30 weeks
12 weeks PFS
Time Frame: measured on 12 weeks
Evaluating 12 weeks PFS rate of HMPL-453 in patient with advanced malignant mesothelioma
measured on 12 weeks
Progression free survival (PFS)
Time Frame: measured on 20 weeks
Evaluating PFS of HMPL-453 in patient with advanced malignant mesothelioma.
measured on 20 weeks
Overall survival (OS)
Time Frame: measured on 60weeks
Evaluating OS of HMPL-453 in patient with advanced malignant mesothelioma
measured on 60weeks
Adverse Event (AE) of HMPL-453 monitoring
Time Frame: Measured from the first dose to within 30 days after the end of treatment.
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.
Measured from the first dose to within 30 days after the end of treatment.
Maximum plasma concentration (Cmax) of HMPL-453
Time Frame: measured on Cycle 1 day 15 and day 16
Evaluating Cmax of Continuous dosing of HMPL-453 in patient with advanced malignant
measured on Cycle 1 day 15 and day 16
The time to Cmax (Tmax) of HMPL-453
Time Frame: measured on Cycle 1 day 15 and day 16
Evaluating Tmax of Continuous dosing of HMPL-453 in patient with advanced malignant
measured on Cycle 1 day 15 and day 16
The area under the plasma concentration-time curve (AUC) of HMPL-453
Time Frame: measured on Cycle 1 day 15 and day 16
Evaluating AUC from 0 to the time of the last measurable concentration of HMPL-453 in patient with advanced malignant
measured on Cycle 1 day 15 and day 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hutchison Medipharma Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shun Lu, Prof., Shanghai Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-453-00CH1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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