Advanced Malignant MesotheliomaPhase 2NCT04290325
HMPL-453 in Advanced Malignant Mesothelioma
A Phase 2 study testing HMPL-453 in people with Advanced Malignant Mesothelioma, run by Hutchison Medipharma Limited at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Mesothelioma
- What is being tested?
- HMPL-453
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2019to 17 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.;
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Chen Yu contact
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, 21000
Shun Lu, MD
About this study
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
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
Read the detailed description
Histologically confirmed patients with advanced malignant mesothelioma that who was failure of the first -line systemic therapy
- Conditions
- Advanced Malignant Mesothelioma
- Being tested
- HMPL-453
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-453Drug
HMPL-453 tablet
| Study group | Role | What they receive |
|---|---|---|
| HMPL-453 | Experimental | HMPL-453 Receives: Drug: HMPL-453 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Evaluating ORR of HMPL-453 in patient with advanced malignant mesothelioma
Measured: 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)
Evaluating DCR of HMPL-453 in patient with advanced malignant mesothelioma
Measured: 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
Evaluating 12 weeks DCR of HMPL-453 in patient with advanced malignant mesothelioma
Measured: measured on 12 weeks
Time to Response (TTR)
Evaluating TTR of HMPL-453 in patient who achieved partial response or complete response according to RECIST 1.1 or mRECIST 1.1
Measured: measured on 4 weeks
Duration of response (DoR)
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.
Measured: measured on 30 weeks
12 weeks PFS
Evaluating 12 weeks PFS rate of HMPL-453 in patient with advanced malignant mesothelioma
Measured: measured on 12 weeks
Progression free survival (PFS)
Evaluating PFS of HMPL-453 in patient with advanced malignant mesothelioma.
Measured: measured on 20 weeks
Overall survival (OS)
Evaluating OS of HMPL-453 in patient with advanced malignant mesothelioma
Measured: measured on 60weeks
Adverse Event (AE) of HMPL-453 monitoring
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.
Measured: Measured from the first dose to within 30 days after the end of treatment.
Maximum plasma concentration (Cmax) of HMPL-453
Evaluating Cmax of Continuous dosing of HMPL-453 in patient with advanced malignant
Measured: measured on Cycle 1 day 15 and day 16
The time to Cmax (Tmax) of HMPL-453
Evaluating Tmax of Continuous dosing of HMPL-453 in patient with advanced malignant
Measured: measured on Cycle 1 day 15 and day 16
The area under the plasma concentration-time curve (AUC) of HMPL-453
Evaluating AUC from 0 to the time of the last measurable concentration of HMPL-453 in patient with advanced malignant
Measured: measured on Cycle 1 day 15 and day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start30 Dec 2019
- Primary completion30 Nov 2022 (estimated)
- Study completion17 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shun Lu, Prof., Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290325
- Sponsor's protocol ID
- 2019-453-00CH1
- Status last verified
- Jun 2020
- First submitted
- 17 Jan 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04290325
- Acronym / sponsor ID
- 2019-453-00CH1
- Conditions
- Advanced Malignant Mesothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 17 Mar 2023 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HMPL-453 | Experimental | Drug: HMPL-453HMPL-453 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (17 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMPL-453HMPL-453 tablet | Drug | HMPL-453 |
Primary outcome
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
11 secondary outcomes
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
12 weeks DCR
Time frame: measured on 12 weeks
Time to Response (TTR)
Time frame: measured on 4 weeks
Duration of response (DoR)
Time frame: measured on 30 weeks
12 weeks PFS
Time frame: measured on 12 weeks
Progression free survival (PFS)
Time frame: measured on 20 weeks
Overall survival (OS)
Time frame: measured on 60weeks
Adverse Event (AE) of HMPL-453 monitoring
Time frame: Measured from the first dose to within 30 days after the end of treatment.
Maximum plasma concentration (Cmax) of HMPL-453
Time frame: measured on Cycle 1 day 15 and day 16
The time to Cmax (Tmax) of HMPL-453
Time frame: measured on Cycle 1 day 15 and day 16
The area under the plasma concentration-time curve (AUC) of HMPL-453
Time frame: measured on Cycle 1 day 15 and day 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Yu contact
Shun Lu, Prof. principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HMPL-453 in people with Advanced Malignant Mesothelioma, run by Hutchison Medipharma Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenjuan Ding (+8602120671806 ext. +8602120671806, Wenjuand@hmplglobal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.