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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02610361




Registration number
NCT02610361
Ethics application status
Date submitted
18/11/2015
Date registered
20/11/2015

Titles & IDs
Public title
Study of the Safety and Pharmacokinetics of BGB-283 in Patients With Solid Tumors
Scientific title
A Phase 1A/1B, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Preliminary Antitumor Activities of the B RAF Inhibitor BGB 283 in Subjects With Solid Tumors
Secondary ID [1] 0 0
ACTRN12614001176651
Secondary ID [2] 0 0
BGB-283-AU-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-283

Experimental: BGB-283 -


Treatment: Drugs: BGB-283
In the dose escalation part(phase 1a): the dose levels will be escalated following a modified 3+3 dose escalation scheme.

In dose expansion phase(Phase 1b): Patients will be assigned to different groups based on their tumor types
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events in phase 1a
Timepoint [1] 0 0
From first dose to within 28 days of last dose of BGB-283, within 1 years in average
Primary outcome [2] 0 0
Objective response rate based on RECIST Version 1.1 in subjects with selected tumor types in phase 1b
Timepoint [2] 0 0
From the first administration of the investigational product to the end of the study treatment, within 1 year in average
Secondary outcome [1] 0 0
Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUClast) in phase 1a
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 in (AUC8) in phase 1a
Timepoint [2] 0 0
During first 2 weeks
Secondary outcome [3] 0 0
Maximum plasma concentration (Cmax) in phase 1a
Timepoint [3] 0 0
During first 2 weeks
Secondary outcome [4] 0 0
Time to reach maximum plasma concentration (tmax) in phase 1a
Timepoint [4] 0 0
During first 2 weeks
Secondary outcome [5] 0 0
Terminal elimination half-life (t1/2) in phase 1a
Timepoint [5] 0 0
During first 2 weeks
Secondary outcome [6] 0 0
Tumor response in phase 1a
Timepoint [6] 0 0
Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, within 1 year in average
Secondary outcome [7] 0 0
Number of participants with adverse events in phase 1b
Timepoint [7] 0 0
From first dose to within 28 days of last dose of BGB-283, within 1 year in average
Secondary outcome [8] 0 0
Progression-free survival (PFS)
Timepoint [8] 0 0
The interval from study treatment initiation until the determination of disease progression or death, within 1 year in average

Eligibility
Key inclusion criteria
1. Provided written informed consent prior to enrollment.
2. Male or female and at least 18 years of age.
3. A life expectancy of at least 12 weeks.
4. Histologically or cytologically confirmed advanced or metastatic solid tumor for which no effective standard therapy is available.
5. One of B-RAF, N-RAS, or K-RAS mutation positive solid tumor.
6. Eastern Cooperative Oncology Group (ECOG) performance status of = 1.
7. Able to swallow and retain oral medication.
8. Adequate bone marrow, liver, and renal function:

* Hemoglobin > 9 g/dL
* Absolute neutrophil count = 1000/mm^3
* Platelets = 100,000/mm^3
* Total bilirubin =1.5 times the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN (= 5 x ULN for subjects with known liver metastasis)
* Creatinine clearance = 45 mL/min (calculated by the Cockcroft Gault formula).
9. Female subjects are eligible to enter and participate in the study if they are of:

a) Non childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who

i) Has had a hysterectomy,

ii) Has had a bilateral oophorectomy (ovariectomy),

iii) Has had a bilateral tubal ligation, or

iv) Is post menopausal (total cessation of menses for = 1 year).

b) Childbearing potential, has a negative serum pregnancy test at screening (within 7 days of the first investigational product administration), and uses adequate contraception before study entry and throughout the study until 28 days after the last investigational product administration. Adequate contraception, when used consistently and in accordance with both the product label and the instructions of the physician, are defined as follows:

i) Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.

ii) Any intrauterine device with a documented failure rate of less than 1% per year.

iii) Double barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; OR diaphragm with spermicide; OR male condom and diaphragm.
10. Subjects with treated brain metastasis are eligible to enter and participate in the study if they are neurologically stable.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Female subjects who are pregnant or lactating.
2. Subjects receiving cancer therapy (chemotherapy or other systemic anti cancer therapies, immunotherapy, radiation therapy, or surgery) at the time of enrollment.
3. Any major surgery within 28 days prior to enrollment.
4. Any radiotherapy within 14 days prior to enrollment, providing the subject has recovered from all toxicities to NCI-CTCAE = Grade 1.
5. Use of any investigational anti cancer drug within 28 days before the first investigational product administration.
6. Unresolved toxicity > Grade 1 (according to NCI-CTCAE, Version 4.03) from previous anti cancer therapy, unless agreed by the sponsor.
7. History or presence of gastrointestinal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
8. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug or to any component of BGB-283. (To date there are no known Food and Drug Administration [FDA] approved drugs chemically related to BGB-283).
9. Untreated leptomeningeal or brain metastasis. Subjects with previously treated brain metastasis that are asymptomatic, off steroids for longer than 28 days are permitted.
10. Any unstable, pre-existing major medical condition that in the opinion of the Investigator contra indicates the use of an investigational product, including active infection, known human immunodeficiency virus (HIV) positive subjects, or known Hepatitis B or C.
11. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
12. As a result of the medical interview, physical examination or screening investigations, the investigator considers the subject unfit for study.
13. Is on medication listed in the protocol or requires any of these medications during treatment with BGB-283.
14. Candidates for curative therapy.
15. Unable or unwilling to comply with the required treatment.

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
20/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2017
Sample size
Target
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
North Coast Cancer Institute - Port Macquarie
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Tasman Oncology Research Ltd - Southport
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [9] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [10] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [11] 0 0
Austin Health - Heidelberg
Recruitment hospital [12] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [13] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [14] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [15] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [16] 0 0
Linear Clinical Research Limited - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
5011 - Woodville South
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3168 - Clayton
Recruitment postcode(s) [11] 0 0
- Heidelberg
Recruitment postcode(s) [12] 0 0
3144 - Malvern
Recruitment postcode(s) [13] 0 0
3004 - Melbourne
Recruitment postcode(s) [14] 0 0
- Melbourne
Recruitment postcode(s) [15] 0 0
- Parkville
Recruitment postcode(s) [16] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Dunedin
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton
Country [4] 0 0
New Zealand
State/province [4] 0 0
Wellington

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Jayesh Desai, 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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Upon request, and subject to certain criteria, conditions, and exceptions, BeiGene will provide access to individual de-identified participant data from BeiGene-sponsored global interventional clinical studies conducted for medicines for indications that have been approved or in programmes that have been terminated. BeiGene will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data requests can be submitted to [email protected].

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Desai J, Gan H, Barrow C, Jameson M, Atkinson V, H... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT02610361