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HMPL-453 in Advanced Malignant Mesothelioma

Published: March 6, 2020

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

Inclusion Criteria

  • Signed written informed consent
  • 18 years of age or older
  • 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
  • Received one to three regimen of prior systemic therapy and then experienced documented radiographic progression or intolerable toxicity
  • Patients agreed to provide tumor tissue for FGF/FGFR testing
  • Measurable disease by RECIST version 1.1 criteria
  • ECOG performance status ≤ 2.

Exclusion Criteria

  • Previous treatment with any FGFR inhibitor;
  • Received systemic anti-cancer therapy within 3 weeks of the first dose of HMPL-453;
  • Major surgery within 4 weeks of the first dose of HMPL-453;
  • Use of a strong inducer or inhibitor of cytochrome P450 3A4 (CYP3A4) within 1 week of the first dose of HMPL-453;
  • 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
  • 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
  • International normalized ratio (INR) >1.5 or activated partial thromboplastin time (aPTT) >1.5 x ULN;
  • Clinical significant liver disease;
  • Known human immunodeficiency virus (HIV) infection
  • Previous history of retinal detachment;
  • NCT04290325</a>Unable to swallow the study drug.
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