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HMPL-453 in Advanced Malignant Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04290325
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited

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

Condition or disease Intervention/treatment Phase
Advanced Malignant Mesothelioma Drug: HMPL-453 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 30, 2019
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : March 17, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arm Intervention/treatment
Experimental: HMPL-453
HMPL-453
Drug: HMPL-453
HMPL-453 tablet




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 12 weeks DCR [ Time Frame: measured on 12 weeks ]
    Evaluating 12 weeks DCR of HMPL-453 in patient with advanced malignant mesothelioma

  3. 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

  4. 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.

  5. 12 weeks PFS [ Time Frame: measured on 12 weeks ]
    Evaluating 12 weeks PFS rate of HMPL-453 in patient with advanced malignant mesothelioma

  6. Progression free survival (PFS) [ Time Frame: measured on 20 weeks ]
    Evaluating PFS of HMPL-453 in patient with advanced malignant mesothelioma.

  7. Overall survival (OS) [ Time Frame: measured on 60weeks ]
    Evaluating OS of HMPL-453 in patient with advanced malignant mesothelioma

  8. 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.

  9. 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

  10. 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

  11. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04290325


Contacts
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Contact: Wenjuan Ding +8602120671806 ext +8602120671806 Wenjuand@hmplglobal.com
Contact: Chen Yu Cheny@hmplglobal.com

Locations
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China
Shanghai Chest Hospital Recruiting
Shanghai, China, 21000
Contact: Shun Lu, MD         
Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
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Principal Investigator: Shun Lu, Prof. Shanghai Chest Hospital
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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT04290325    
Other Study ID Numbers: 2019-453-00CH1
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mesothelioma
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases