Status:
UNKNOWN
HMPL-453 in Advanced Malignant Mesothelioma
Lead Sponsor:
Hutchison Medipharma Limited
Conditions:
Advanced Malignant Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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;
- Unable to swallow the study drug.
Key Trial Info
Start Date :
December 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 17 2023
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04290325
Start Date
December 30 2019
End Date
March 17 2023
Last Update
June 16 2020
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, China, 21000