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HMPL-453 in Advanced Malignant Mesothelioma

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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

Tracking Information
First Submitted Date  ICMJE January 17, 2020
First Posted Date  ICMJE February 28, 2020
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE December 30, 2019
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2020)
  • 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
  • 12 weeks DCR [ Time Frame: measured on 12 weeks ]
    Evaluating 12 weeks DCR of HMPL-453 in patient with advanced malignant mesothelioma
  • 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
  • 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.
  • 12 weeks PFS [ Time Frame: measured on 12 weeks ]
    Evaluating 12 weeks PFS rate of HMPL-453 in patient with advanced malignant mesothelioma
  • Progression free survival (PFS) [ Time Frame: measured on 20 weeks ]
    Evaluating PFS of HMPL-453 in patient with advanced malignant mesothelioma.
  • Overall survival (OS) [ Time Frame: measured on 60weeks ]
    Evaluating OS of HMPL-453 in patient with advanced malignant mesothelioma
  • 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.
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HMPL-453 in Advanced Malignant Mesothelioma
Official Title  ICMJE A Phase II, Single Arm, Multicenter and Open Labelstudy Evaluating the Efficacy, Safety and Pharmacokinetics of HMPL-453 in Patient With Advanced Malignant Mesothelioma
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Malignant Mesothelioma
Intervention  ICMJE Drug: HMPL-453
HMPL-453 tablet
Study Arms  ICMJE Experimental: HMPL-453
HMPL-453
Intervention: Drug: HMPL-453
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 27, 2020)
27
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 17, 2023
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wenjuan Ding +8602120671806 ext +8602120671806 Wenjuand@hmplglobal.com
Contact: Chen Yu Cheny@hmplglobal.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04290325
Other Study ID Numbers  ICMJE 2019-453-00CH1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hutchison Medipharma Limited
Study Sponsor  ICMJE Hutchison Medipharma Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shun Lu, Prof. Shanghai Chest Hospital
PRS Account Hutchison Medipharma Limited
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP