Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000133730
Ethics application status
Approved
Date submitted
23/01/2013
Date registered
4/02/2013
Date last updated
4/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase I Study of the Volitinib (HMPL-504) in Patients With Advanced Solid Tumors
Scientific title
A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HMPL-504 in Patients With Advanced Solid Tumors
Secondary ID [1] 281813 0
None
Universal Trial Number (UTN)
Trial acronym
HMPL-504
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior systemic therapy
 288162 0
Condition category
Condition code
Cancer 288526 288526 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volitinib(HMPL-504) is a tablet in the form of 25 mg ,100mg and 200mg,oral,once daily.
There are six dose cohorts,including 100, 200, 400, 600,800 and 1000 mg/day, HMPL-504 will be administered orally to patients once daily for each dose cohort.and one cohort contains 21 days.
Intervention code [1] 286363 0
Treatment: Drugs
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288683 0
The safety and tolerability of single and multiple doses of HMPL-504 administered to patients,The safety and tolerability variables to be evaluated in this study are adverse events, physical examinations, vital signs ,clinical laboratory evaluations including serum chemistry, hematology , and urinalysis , and electrocardiograms (ECGs) in triplicate,Incidence and nature of DLTs(Dose-Limiting Toxicity),To determine the MTD (Maximum Tolerated Dose).
Timepoint [1] 288683 0
up to 20 months
Secondary outcome [1] 300756 0
Pharmacokinetic Assessments for area under curve (AUC), Cmax and Tmax
Timepoint [1] 300756 0
Day 1-3 Single Dose and Day 1-21 Steady State

Eligibility
Key inclusion criteria
Signed Informed Consent Form ,locally advanced, or metastatic solid malignancy ;Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1;Male or female patients of child-producing potential must agree to take contraception measures to avoidance of pregnancy during the study and for 90 days after the last day of treatment;
Patients with gastric cancer , NSCLC, colorectal cancer, breast cancer and hepatocellular carcinoma(HCC) are preferred to be enrolled into the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inadequate hematologic and organ function, defined by the following ;
Clinical significant active infection;
Adverse events from prior anti-cancer therapy that have not resolved to Grade = 1, except for alopecia;
Pregnant or lactating women;
History of myocardial infarction ;
Active or untreated brain metastasis;

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
There are six dose cohorts,including 100, 200, 400, 600,800 and 1000 mg/day, HMPL-504 will be administered orally to patients once daily for each dose cohort
An alternative dosing schedule of twice every day (BID) may be investigated if pharmacokinetic studies indicate faster than anticipated clearance of Volitinib(HMPL-504).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a multiple-center, open-label, dose-escalation study .
Patients will be assigned to dose levels sequentially in which they are enrolled.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
There are two stages to this study : a dose-escalation stage and a dose-expansion stage.
The dose-escalation stage is designed to evaluate the safety, tolerability, and pharmacokinetics of HMPL-504 given once every day (QD).
Once the Maximum Tolerated Dose (MTD) or the recommended phase 2 dose (RPTD)has been established, an additional up to 10 patients will be enrolled in the dose-expansion stage at the MTD or RPTD to better characterize the safety, tolerability and PK variability of the specific HMPL-504 dose.
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis
The final analysis will be based on patient data collected through study discontinuation or study termination. All analyses will be based on the safety-evaluable population, which is defined as all patients who receive any amount of HMPL-504. All summaries will be presented by assigned dose level.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/02/2012
Actual
15/02/2012
Date of last participant enrolment
Anticipated
30/06/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC

Funding & Sponsors
Funding source category [1] 286602 0
Commercial sector/Industry
Name [1] 286602 0
Hutchison Medipharma Ltd
Country [1] 286602 0
China
Primary sponsor type
Commercial sector/Industry
Name
Hutchison Medipharma Ltd
Address
Building 4 720 Cai Lun Road Zhangjiang Hi-Tech Park
Shanghai China 201203
Country
China
Secondary sponsor category [1] 285389 0
None
Name [1] 285389 0
none
Address [1] 285389 0
none
Country [1] 285389 0
Other collaborator category [1] 277256 0
Hospital
Name [1] 277256 0
Linear Clinical Research Ltd
Address [1] 277256 0
229 Greenhill Road Dulwich SA 5065
Country [1] 277256 0
Australia
Other collaborator category [2] 277257 0
Hospital
Name [2] 277257 0
Austin Health
Address [2] 277257 0
145 Studley Road PO Box 5555 Heidelberg Victoria Australia 3084
Country [2] 277257 0
Australia
Other collaborator category [3] 277258 0
Hospital
Name [3] 277258 0
Monash Medical Centre
Address [3] 277258 0
246 Clayton Road Clayton VIC 3168, Australia
Country [3] 277258 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288676 0
the Bellberry Human Research Ethics
Ethics committee address [1] 288676 0
Hospital Avenue,Nedlands Perth 6009 ,Westem Australia
Ethics committee country [1] 288676 0
Australia
Date submitted for ethics approval [1] 288676 0
16/01/2012
Approval date [1] 288676 0
31/01/2012
Ethics approval number [1] 288676 0
2011-09-459-A-1
Ethics committee name [2] 288709 0
Austin Health Human Research Ethics Committee
Ethics committee address [2] 288709 0
145 Studly Road PO Box 5555 Heidelberg Victoria Australia 3084
Ethics committee country [2] 288709 0
Australia
Date submitted for ethics approval [2] 288709 0
13/01/2012
Approval date [2] 288709 0
31/01/2012
Ethics approval number [2] 288709 0
HREC/11/Auston/50

Summary
Brief summary
A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HMPL-504 in Patients with Advanced Solid Tumors.
You may be eligible to join this study if you are aged 18 years or more and have been diagnosed with incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior systemic therapy. Trial details Participants in this trial will be allocated to take Volitinib (HMPL-504) tablets once daily for a period of [a cohort /21 days] at one of six dose levels (100, 200, 400, 600, 800 or 1000 mg/day). Patients will be assigned to dose levels sequentially as they are enrolled. Participants will be assessed for up to 20 months in order to determine safety and tolerability of the treatment. They will also be asked to give blood samples to assess the pharmacokinetics (i.e. action of the drug in the body) over a 21 day period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37214 0
Prof Hui Gan
Address 37214 0
145 Studley Road PO Box 5555 Heidelberg Victoria Australia 3084
Country 37214 0
Australia
Phone 37214 0
+ 61 3 9496 5354
Fax 37214 0
+ 61 3 9457 6698
Email 37214 0
Hui.Gan@ludwig.edu.au
Contact person for public queries
Name 37215 0
Dr Charlie Qi
Address 37215 0
Hutchison MediPharma Limited
Building 4 720 Cai Lun Road Zhangjiang Hi-Tech Park
Shanghai China 201203
Country 37215 0
China
Phone 37215 0
+86 21 5079 0088
Fax 37215 0
86 21 50793597
Email 37215 0
charlieq@hmplglobal.com
Contact person for scientific queries
Name 37216 0
Mr Hua Mu
Address 37216 0
Hutchison MediPharma Limited
Building 4 720 Cai Lun Road Zhangjiang Hi-Tech Park
Shanghai China 201203
Country 37216 0
China
Phone 37216 0
+86 21 5079 0088
Fax 37216 0
86 21 50793597
Email 37216 0
HuaMu@hmplglobal.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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