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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02759666




Registration number
NCT02759666
Ethics application status
Date submitted
29/04/2016
Date registered
3/05/2016
Date last updated
19/09/2019

Titles & IDs
Public title
A Phase I Trial of SHR3162 in Subjects With Advanced Solid Tumors
Scientific title
A Multicenter, Open-Label, Phase 1 Trial of SHR3162 Given Orally to Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
SHR3162-002
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 - SHR3162

Experimental: SHR3162 - 3 to 6 participants (traditional "3+3" design) will be enrolled in 6 dose levels. SHR3162 was administered once daily in dose levels 1 and 2 and will be administered twice daily in dose levels 3 to 6.


Treatment: Drugs: SHR3162
SHR3162 capsule(s) is administered orally QD.
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
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 versus 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
Clearance (CL)
Timepoint [5] 0 0
4 weeks
Secondary outcome [6] 0 0
Volume of distribution at steady state (Vss)
Timepoint [6] 0 0
4 weeks

Eligibility
Key inclusion criteria
1. Males and/or females over age 18.

2. Ability to understand the purposes and risks of the trial and his/her signed informed
consent form approved by Human Research Ethics Committee (HREC) of the trial site was
obtained before the entering the trial.

3. Histologically or cytologically confirmed advanced or metastatic solid tumor for which
no established standard therapy is available.

4. At least one measurable lesion by CT or MRI according to RECIST Version 1.1, which is
not in irradiated area (only for expansion phase).

5. Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (in case
of alopecia, Grade 2 is acceptable).

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

7. Life expectancy of at least 3 months.

8. Acceptable liver function defined below:

- Total bilirubin =1.5 times upper limit of normal (ULN);

- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3 times ULN;
however, =5 times ULN in a participant who has liver metastases or is treated
with biliary drainage

9. Acceptable renal function defined below:

- Serum creatinine =1.5 times ULN or calculated creatinine clearance (by the
Cockcroft-Gault formula) =60 mL/minutes

10. Acceptable coagulation status defined below:

- Prothrombin time <1.3 times ULN

- Partial thrombin time <1.3 times ULN

11. 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

12. No clinically significant abnormalities in urinalysis.

13. Female participants of child bearing potential agree not to be pregnant or lactating
during the study and for three months following the last dose of study drug. Both men
and women of reproductive potential must agree to use a highly effective method of
birth control during the study and for three months following the last dose of study
drug. A highly effective method of contraception is defined as one that results in a
low failure rate (i.e., less than 1% per year) when used consistently and correctly.
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. Previously treated malignancies other than the current disease, except for adequately
treated non-melanoma skin cancer, in situ cancer, or other cancer from which the
subject has been disease-free for at least 5 years at the trial entry.

4. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
therapy

5. Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry,
without complete recovery.

6. Percutaneous coronary intervention conducted within 6 months prior to the trial entry
for cardiac infarction or angina pectoris.

7. Seizure disorders requiring anticonvulsant therapy.

8. Taking a medication that prolongs QT interval and has a risk of Torsade de Pointes, or
a history of long QT syndrome.

9. Medical history of difficulty swallowing, malabsorption or other chronic
gastrointestinal disease, or conditions that may hamper compliance and/or absorption
of the tested product.

10. Anti-cancer treatment with radiation therapy, surgery, chemotherapy, targeted
therapies (erlotinib, lapatinib, etc.), hormone therapy, or immunotherapy within 4
weeks (6 weeks for nitrosoureas or Mitomycin C) prior to trial entry, and ever use
PARP inhibitor.

11. Participation in an investigational drug or device trial within 4 weeks prior to the
trial entry.

12. Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.

13. Recent venous thrombosis (including deep vein thrombosis or pulmonary embolism within
1 year of study).

14. History of upper gastrointestinal hemorrhage, peptic ulcer disease, or bleeding
diathesis.

15. 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.

16. History of organ allograft, autologous stem cell transplantation, or allogeneic -

17. 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.

18. Unwillingness or inability to comply with the trial protocol for any reason.

19. Legal incapacity or limited legal capacity.

20. Known drug abuse or alcohol abuse.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
1/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/04/2019
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Border Medical Oncology - Albury
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Linear - Melbourne
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
- Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label, multicenter, non-randomized, dose-escalation phase 1 trial to evaluate
the safety and tolerability of SHR3162 in participants with advanced solid tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02759666
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