HMPL-453 in Advanced Malignant Mesothelioma

NCT04290325 | Unknown Phase 2

• 1 other identifier: 2019-453-00CH1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Malignant Mesothelioma

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  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 Outcomes (11)

• Disease control rate (DCR)

  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

  measured on 12 weeks

• Time to Response (TTR)

  measured on 4 weeks

• Duration of response (DoR)

  measured on 30 weeks

• 12 weeks PFS

  measured on 12 weeks

Study Arms (1)

HMPL-453

EXPERIMENTAL

HMPL-453

Drug: HMPL-453

Interventions

HMPL-453 DRUG

HMPL-453 tablet

HMPL-453

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent;
• 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.;

You may not qualify if:

• 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

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, 21000, China

RECRUITING

Study Officials

• Shun Lu, Prof.

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjuan Ding

CONTACT

+8602120671806; Wenjuand@hmplglobal.com

Chen Yu

CONTACT

Cheny@hmplglobal.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: February 28, 2020
• Study Start: December 30, 2019
• Primary Completion: November 30, 2022
• Study Completion: March 17, 2023
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)