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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01773018




Registration number
NCT01773018
Ethics application status
Date submitted
15/01/2013
Date registered
21/01/2013

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] 0 0
2011-504-00AU1
Universal Trial Number (UTN)
Trial acronym
HMPL-504
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Volitinib

Experimental: Volitinib(HMPL-504) - 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).


Treatment: Drugs: Volitinib
Volitinib(HMPL-504) is a tablet in the form of 25 mg ,100mgand 200 mg,oral,once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The safety and tolerability of single and multiple doses of HMPL-504 administered to patients.
Timepoint [1] 0 0
up to 20 months
Secondary outcome [1] 0 0
Pharmacokinetic Assessments for area under curve (AUC), Cmax and Tmax .
Timepoint [1] 0 0
Day 1-3 Single Dose and Day 1-21 Steady State

Eligibility
Key inclusion criteria
* Signed Informed Consent Form
* Age=18 years
* 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
* Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
* Male or female patients of child-producing potential must agree to use double barrier contraception, condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD), contraceptives (oral or parenteral), Implanon, injectables or other avoidance of pregnancy measures during the study and for 90 days after the last day of treatment
* In the dose expansion stage, the patient's informed consent to providing fresh biopsy tumor sample at baseline and day 7 should be obtained. Patients with gastric cancer , NSCLC, colorectal cancer, breast cancer and hepatocellular carcinoma(HCC) are preferred to be enrolled into the dose expansion cohort.
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 (hematologic parameters must be assessed =14 days after a prior treatment, if any):

* Absolute neutrophil count <1500 cells/L
* Hemoglobin <9 g/dL
* Total bilirubin >1.5 × the upper limit of normal (ULN) with the following exception: Patients with known Gilbert disease who have

serum bilirubin level =3× the upper limit of normal(ULN) and normal AST/ALT may be enrolled.

* Aspartate aminotransferase (AST) and/or Alanine transaminase(ALT) >2.5 × the upper limit of normal(ULN) with the following exception: Patients with documented liver metastases may have AST and/or ALT levels =5 ×the upper limit of normal(ULN).
* Serum creatinine >1.5 × the upper limit of normal (ULN) with the following exception: A creatinine clearance of =50 mL/min based on a documented 24-hour urine collection.
* International normalized ratio (INR)>1.5× the ULN or activated partial thromboplastin time (aPTT)>1.5×the ULN
* The INR applies only to patients who do not receive therapeutic anti-coagulation.

• Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy, radiotherapy, or herbal therapy within 4 weeks prior to initiation of study treatment with the following exceptions:
* Hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists for prostate cancer
* Hormone-replacement therapy or oral contraceptives
* Palliative radiation to bone metastases > 2 weeks prior to Day 1
* Herbal therapy >1 week prior to Day 1

* Adverse events from prior anti-cancer therapy that have not resolved to Grade = 1, except for alopecia
* Clinical significant active infection
* Known clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
* Known human immunodeficiency virus infection
* Pregnant (positive pregnancy test) or lactating women
* New York Heart Association (NYHA) Class II or greater congestive heart failure
* History of myocardial infarction or unstable angina within 6 months prior to Day 1
* History of stroke or transient ischemic attack within 6 months prior to Day 1
* Active or untreated brain metastasis
* Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease
* Inability to comply with study and follow-up procedures
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 0 0
Southern Health and Monash Institute of Medical Research - Clayton
Recruitment hospital [3] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hutchison Medipharma Limited
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Sir Charles Gairdner Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Austin Hospital, Melbourne Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Monash University
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Millward, MD,Ph.D
Address 0 0
Sir Charles Gairdner Hospital & University of WA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01773018