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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02759640




Registration number
NCT02759640
Ethics application status
Date submitted
29/04/2016
Date registered
3/05/2016

Titles & IDs
Public title
A Phase I Trial of HS-10241 in Solid Tumors
Scientific title
First-in-Human, Dose-Escalation Trial of C-Met Kinase Inhibitor HS-10241 in Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
HS-10241-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasm 0 0
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HS-10241

Experimental: HS-10241 - HS-10241 is administered orally starting at 100 mg/day.


Treatment: Drugs: HS-10241
HS-10241 is administered orally starting at 100 mg/day.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum tolerated dose (MTD)
Timepoint [1] 0 0
4 weeks
Secondary outcome [1] 0 0
Number of participants with treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Peak plasma concentration (Cmax)
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
Area under the plasma concentration-time curve (AUC)
Timepoint [3] 0 0
4 weeks
Secondary outcome [4] 0 0
T1/2 (half-life)
Timepoint [4] 0 0
4 weeks
Secondary outcome [5] 0 0
Objective response rate (ORR)
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Time to reach maximum plasma concentration (Tmax)
Timepoint [6] 0 0
4 weeks
Secondary outcome [7] 0 0
Clearance (CL)
Timepoint [7] 0 0
4 weeks
Secondary outcome [8] 0 0
Volume of distribution at steady state (Vss)
Timepoint [8] 0 0
4 weeks

Eligibility
Key inclusion criteria
1. At least 18 years of age
2. Ability to understand the purposes and risks of the trial and his/her informed consent using the Human Research Ethics Committee (HREC) approved informed consent form (ICF).
3. Histologically or cytologically confirmed advanced or metastatic solid tumor for which standard therapy does not exist, has failed, or has been refused.
4. Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (except alopecia)
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Life expectancy of at least 3 months
7. Acceptable liver function defined below:

* Total bilirubin = 2 times upper limit of normal range (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3 times ULN; however, =5 times ULN in a subject who has liver metastases
8. Acceptable renal function defined below:

* Serum creatinine =1.5 times ULN or calculated creatinine clearance (by the Cockcroft-Gault formula) =60 mL/minutes
9. Acceptable coagulation status defined below:

* Prothrombin time <1.5 times ULN
* Partial thrombin time <1.5 times ULN
10. Acceptable hematologic status (without hematologic supports including hematopoietic factor, blood transfusion) defined below:

* Absolute neutrophil count (ANC) =1500/µL
* Platelet count =100000/µL
* Hemoglobin =9.0 g/dL
11. No clinically significant abnormalities in urinalysis
12. All participants must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an intrauterine device) with their partner from entry into the trial through 6 months after the last dose.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Hematologic malignancies
2. Cardiac disease with New York Heart Association (NYHA) Class III or IV, including congestive heart failure, myocardial infarction within 6 months prior to the trial entry, unstable arrhythmia, or symptomatic peripheral arterial vascular disease
3. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
4. Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery
5. Percutaneous coronary intervention conducted within 6 months prior to the trial entry for cardiac infarction or angina pectoris
6. Seizure disorders requiring anticonvulsant therapy
7. Taking a medication that prolongs QT interval and has a risk of Torsade de Pointes, or a history of long QT syndrome
8. Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product
9. Anti-cancer treatment with radiation therapy, surgery, chemotherapy, targeted therapies (erlotinib, lapatinib, etc.), or immunotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin C) prior to trial entry. Ongoing androgen deprivation therapy or bisphosphonates are allowed.
10. Participation in an investigational drug or device trial within 4 weeks prior to the trial entry
11. Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
12. Recent venous thrombosis (including deep vein thrombosis or pulmonary embolism within 1 year of trial entry)
13. History of upper gastrointestinal hemorrhage, peptic ulcer disease, or bleeding diathesis;
14. Subject is pregnant (positive serum beta human chorionic gonadotropin [ß-HCG] test at Screening) or is currently breast-feeding, their partner anticipates becoming pregnant/impregnating during the trial or within 6 months after receiving the last dose of trial treatment
15. Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial
16. History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation
17. Unwillingness or inability to comply with the trial protocol for any reason
18. Legal incapacity or limited legal capacity
19. Known drug abuse or alcohol abuse
20. Taking a medication that is a moderate or strong inhibitor or inducer of CYP2C9. Patients are eligible if these medications can be stopped or substituted within the screening period.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
1/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2018
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Liverpool - Liverpool
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT02759640