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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02569476




Registration number
NCT02569476
Ethics application status
Date submitted
18/09/2015
Date registered
6/10/2015
Date last updated
3/01/2019

Titles & IDs
Public title
BGB 3111 in Combination With Obinutuzumab in Subjects With B-Cell Lymphoid Malignancies
Scientific title
A Phase 1b Study to Assess Safety, Tolerability and Antitumor Activity of the Combination of BGB 3111 With Obinutuzumab in Subjects With B-Cell Lymphoid Malignancies
Secondary ID [1] 0 0
BGB-3111_GA101_Study_001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: BGB-3111 and obinutuzumab - In the dose-escalation part, the dose levels and regimens will be evaluated. In the indication-specific expansion cohorts, patients will be assigned to different cohorts based on histology type.


Treatment: Drugs: BGB-3111 and Obinutuzumab


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

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events
Timepoint [1] 0 0
From first dose to withhin 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
the first 6 months
Secondary outcome [2] 0 0
Area under the plasma concentration-time curve from time 0 to infinity time (AUC8)
Timepoint [2] 0 0
the first 6 months
Secondary outcome [3] 0 0
Maximum plasma concentration (Cmax)
Timepoint [3] 0 0
the first 6 months
Secondary outcome [4] 0 0
Terminal elimination half-life (t1/2)
Timepoint [4] 0 0
the first 6 months
Secondary outcome [5] 0 0
BTK inhibition activity of BGB-3111 by measurement of free BTK
Timepoint [5] 0 0
the first 6 months
Secondary outcome [6] 0 0
Tumor response
Timepoint [6] 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
- Aged =18 years, able and willing to provide written informed consent and to comply
with the study protocol.

- Laboratory parameters as specified below:

- Hematologic: Platelet count >40x10^9/L (may be post-transfusion); absolute
neutrophil count >1.0x10^9/L (growth factor use is allowed to bring pre-treatment
neutrophils to >1.0x10^9 cells/L if marrow infiltration is involved).

- Hepatic: Total bilirubin <3 x upper limit normal (ULN); and aspartate
aminotransferase (AST) and alanine transaminase (ALT) =3xULN.

- Renal: Creatinine clearance =50 mL/min (as estimated by the Cockcroft Gault
equation or as measured by nuclear medicine scan or 24 hour urine collection);
subjects requiring hemodialysis will be excluded.

- Anticipated survival of at least 6 months.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

- Female subjects of childbearing potential and non-sterile males must agree to practice
at least one of the following methods of birth control with partner(s) throughout the
study and for =3 months after discontinuing BGB-3111 or =18 months following
obinutuzumab treatment, whichever is longer: total abstinence from sexual intercourse,
double barrier contraception, intra uterine device (IUD) or hormonal contraceptive
initiated at least 3 months prior to first administration of study drug.

- Male subjects must not donate sperm from first study drug administration, until 3
months after BGB-3111 discontinuation or 18 months following obinutuzumab treatment,
whichever is longer.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known central nervous system lymphoma or leukemia.

- Known prolymphocytic leukemia or history of, or currently suspected, Richter's
syndrome.

- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.

- History of significant cardiovascular disease.

- Severe or debilitating pulmonary disease.

- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy.

- Prior BTK inhibitor treatment.

- Using medications which are strong cytochrome P450 (CYP) 3A inhibitors and strong
CYP3A inducers.

- Vaccination with a live vaccine within 28 days of the initiation of treatment.

- Allogeneic stem cell transplantation within 6 months, or has active graft versus host
disease (GvHD) requiring ongoing immunosuppression.

- Receipt of the following treatment prior to first administration of BGB 3111,
corticosteroids given with anti-neoplastic intent within 7 days, chemotherapy or
radiotherapy within 3 weeks, monoclonal antibody within 4 weeks.

- Participate in any investigational drug study within 28 days of study entry, or not
recovered from non-hematologic toxicity of any prior chemotherapy up to = Grade 1
(except for alopecia).

- History of other active malignancies within 2 years of study entry.

- Major surgery in the past 4 weeks.

- Active symptomatic fungal, bacterial and/or viral infection including evidence of
infection with human immunodeficiency virus (HIV), human T cell lymphotropic virus
(HTLV 1) seropositive status.

- Inability to comply with the study procedures.

- Pregnant or nursing women.

- Any illness or condition that in the opinion of the investigator may affect the safety
of treatment or evaluation of any study's endpoints.

Study design
Purpose of the study
Treatment
Allocation to intervention
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
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,SA,VIC,WA
Recruitment hospital [1] 0 0
Border Medical Oncology - Albury
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Brisbane Clinic for Lymphoma, Myeloma and Leukaemia - Greenslopes
Recruitment hospital [4] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [5] 0 0
St Vincent's Hospital Melbourne - East Melbourne
Recruitment hospital [6] 0 0
University Hospital Geelong - Geelong
Recruitment hospital [7] 0 0
St Frances Xavier Cabrini Hospital - Malvern
Recruitment hospital [8] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [9] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
3144 - Malvern
Recruitment postcode(s) [8] 0 0
3181 - Melbourne
Recruitment postcode(s) [9] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Seoul

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is evaluating the safety and preliminary efficacy of BGB-3111 in combination with
obinutuzumab in subjects with B-cell lymphoid malignancies.
Trial website
https://clinicaltrials.gov/show/NCT02569476
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

Summary results
Other publications