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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03901950




Registration number
NCT03901950
Ethics application status
Date submitted
2/04/2019
Date registered
3/04/2019

Titles & IDs
Public title
Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of XNW7201 in Subjects With Advanced Solid Tumors
Scientific title
A Phrase I, Open-label, Multi-center, Non-randomized, Does Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of XNW7201 in Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
XNW7201-1-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - XNW7201 tablets

Experimental: XNW7201 -


Treatment: Drugs: XNW7201 tablets
A wnt pathway inhibitor
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of XNW7201 tablets in subjects with advanced solid tumor;
Timepoint [1] 0 0
From date of first dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to about 6 months
Primary outcome [2] 0 0
The dose-limiting toxicity (DLT) of XNW7201
Timepoint [2] 0 0
At the end of Cycle 1 (each cycle is 30 days)

Eligibility
Key inclusion criteria
* 1. Subjects who are voluntary to participate in this clinical study, able to understand the study procedure and have signed the informed consent form;

2. Male or female subjects =18 years of age;

3. Subjects with histologically or cytologically confirmed advanced solid tumors after failure of standard of care, or intolerability to standard of care, or with no standard of care;

4. ECOG Performance Status of 0 or 1 at both the screening and baseline visits;

5. Life expectancy =12 weeks;

6. Subjects with at least one measurable lesion in accordance with RECIST 1.1(not required for dose escalation part);

7. Adequate laboratory parameters during screening as evidenced by:
* Adequate bone marrow reserve: absolute neutrophil count (ANC) =1.5×109/L, platelet count =100×109/L and hemoglobin =90 g/dL;
* Basically normal liver function: total bilirubin = 1.5 × upper limit of normal (ULN); ALT and AST=2.5 × ULN or = 5 × ULN when metastases to liver occurs;
* Normal renal function: serum creatinine level>1.5 × ULN or endogenous creatinine clearance <60 mL/min (using Cockcroft-Gault formula);
* Basically normal coagulation: prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (APTT) = 1.5 × ULN;
* Cardiac function: left ventricular ejection fraction (LVEF) =50%; basically normal ECG, QTcF interval=70 ms (QTc interval corrected by Fridericia's Correction Formula);
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 1. Known or suspected history of allergy to XNW7201 tablet and its metabolite or its excipients;

2. Subjects who previously received treatment with WNT inhibitor;

3. Subjects with one of the various factors affecting absorption of oral drugs (e.g., inability to swallow, chronic diarrhoea and intestinal obstruction) or active gastrointestinal disorder, gastric bypass or other diseases that could significantly affect drug absorption, distribution, metabolism or excretion;

4. Presence of CTCAE Grade > 1 adverse events induced by previous treatment that is still not relieved prior to the first dose, not including alopecia and tolerable adverse event as judged by investigators;

5. Participation in other clinical studies within 4 weeks prior to the first dose of XNW7201;

6. Any chemotherapy, biotherapy, radiotherapy, hormone therapy, targeted anti-tumor therapy (excluding nitrosourea and mitomycin C) administered within 4 weeks before the first dose of the investigational drug); nitrosourea or mitomycin C administered within 6 weeks before the first dose of the investigational drug;

7. Major surgery or active ulcer or incomplete healing of wound within 4 weeks prior to the first dose;

8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirement or compromise the ability of the subject to give written informed consent;

9. Any unstable, pre-existing major medical condition that in the opinion of the investigator contraindicates the use of the investigational drug, including known human immunodeficiency (HIV) or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;

10. Women who are pregnant or breastfeeding.

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
1/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2022
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Integrated Clinical Oncology network Pty Ltd - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Evopoint Biosciences Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Jason Le
Address 0 0
Evopoint Biosciences Inc.
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/NCT03901950