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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02343120




Registration number
NCT02343120
Ethics application status
Date submitted
9/01/2015
Date registered
21/01/2015
Date last updated
5/02/2020

Titles & IDs
Public title
Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies
Scientific title
A Phase I/II, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety and Pharmacokinetics of the BTK Inhibitor BGB-3111 in Subjects With B-Cell Lymphoid Malignancies
Secondary ID [1] 0 0
2016-003364-39
Secondary ID [2] 0 0
BGB-3111-AU-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
B-cell Malignancies 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-3111

Experimental: BGB-3111 - All patients will undertake 160MG BID of BGB-3111.


Treatment: Drugs: BGB-3111
In the dose-escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme.
In the safety, schedule and efficacy expansion part, patients will be assigned to different cohorts based on histology type.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events - Creating a safety profile
Timepoint [1] 0 0
From first dose to within 28 days of last dose of BGB-3111
Secondary outcome [1] 0 0
Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUClast)
Timepoint [1] 0 0
During first 2 weeks
Secondary outcome [2] 0 0
Area under the plasma concentration-time curve from time 0 to infinity time (AUC8)
Timepoint [2] 0 0
During first 2 weeks
Secondary outcome [3] 0 0
Maximum plasma concentration (Cmax)
Timepoint [3] 0 0
During first 2 weeks
Secondary outcome [4] 0 0
Time to reach maximum plasma concentration (tmax)
Timepoint [4] 0 0
During first 2 weeks
Secondary outcome [5] 0 0
Terminal elimination half-life (t1/2)
Timepoint [5] 0 0
During first 2 weeks
Secondary outcome [6] 0 0
BTK inhibition activity of BGB-3111 by measurement of free BTK
Timepoint [6] 0 0
During first 2 weeks
Secondary outcome [7] 0 0
Tumor response
Timepoint [7] 0 0
Every 12 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Eligibility
Key inclusion criteria
1. Aged = 18 years, voluntarily consented to the study.

2. WHO classification defined B-lymphoid malignancy, with the exception of Burkitt
lymphoma/leukemia, plasma cell myeloma, acute lymphoblastic leukemia, lymphoblastic
lymphoma, and plasmablastic lymphoma.

3. Requirement for treatment in the opinion of the investigator.

4. Disease which has relapsed, or is refractory, following at least one line of therapy,
with no therapy of higher priority available.

5. ECOG performance status of 0-2.

6. Adequate hematologic function, as defined by neutrophils = 1.0 x 10^9/L and platelets
= 50 x 10^9/L; patients with neutrophils < 1.0 x 10^9/L due to marrow infiltration are
allowed to receive growth factors to bring pre-treatment neutrophils to = 1.0 x
10^9/L.

7. Adequate renal function, as defined by creatinine clearance of = 50 ml/min (as
estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or
24 hour urine collection).

8. Adequate liver function, as defined by AST and ALT = 3 x ULN, and bilirubin = 1.5 x
ULN (unless documented Gilbert's syndrome).

9. INR and APTT = 1.5 x ULN.

10. Female subjects of childbearing potential and non-sterile males must practice at least
one of the following methods of birth control with partner(s) throughout the study and
for 90 days after discontinuing study drug: total abstinence from sexual intercourse,
double-barrier contraception, IUD or hormonal contraceptive initiated at least 3
months prior to first dose of study drug.

11. Male subjects must not donate sperm from initial study drug administration, until 90
days after drug discontinuation.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current CNS involvement by disease

2. Current histologically transformed disease.

3. Prior BTK inhibitor treatment.

4. Allogeneic stem cell transplantation within 6 months, or has active GVHD requiring
ongoing immunosuppression.

5. Receipt of the following treatment prior to first dose of BGB-3111: corticosteroids
given with anti-neoplastic intent within 7 days, chemotherapy or radiotherapy within 2
weeks, monoclonal antibody within 4 weeks.

6. Not recovered from toxicity of any prior chemotherapy to grade = 1.

7. History of other active malignancies within 2 years of study entry, with exception of
(1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or
squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally
(surgery or other modality) with curative intent.

8. Uncontrolled systemic infection requiring parenteral anti-microbial therapy.

9. Major surgery in the past 4 weeks.

10. Known HIV, or active hep B or hep C infection (detected positive by PCR).

11. Cardiovascular disease resulting in New York Heart Association function status of = 3.

12. Significant active renal, neurologic, psychiatric, hepatic or endocrinologic disease
that in the investigator's opinion would adversely impact on his/her participating in
the study.

13. Inability to comply with study procedures.

14. On medications which are CYP3A inhibitors.

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/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
St George Hospital - Sydney
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [5] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [6] 0 0
Monash Health - Clayton
Recruitment hospital [7] 0 0
Austin Health - Heidelberg
Recruitment hospital [8] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [9] 0 0
Peter MacCallum Cancer Centre, East Melbourne - Parkville
Recruitment hospital [10] 0 0
Melbourne Health - Parkville
Recruitment hospital [11] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment postcode(s) [4] 0 0
- Brisbane
Recruitment postcode(s) [5] 0 0
- Hobart
Recruitment postcode(s) [6] 0 0
- Clayton
Recruitment postcode(s) [7] 0 0
- Heidelberg
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
- Parkville
Recruitment postcode(s) [11] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Italy
State/province [5] 0 0
Bologna
Country [6] 0 0
Italy
State/province [6] 0 0
Milano
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Busan
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Goyang-si
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Seoul
Country [10] 0 0
New Zealand
State/province [10] 0 0
Auckland
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Devon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment
effect of a new drug known as BGB-3111 in patients with B-Cell Lymphoid Malignancies.
Trial website
https://clinicaltrials.gov/show/NCT02343120
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Constantine Tam, MD
Address 0 0
Peter MacCallum Cancer Centre, Australia
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

Summary results
Other publications