Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02407990
Registration number
NCT02407990
Ethics application status
Date submitted
26/03/2015
Date registered
3/04/2015
Date last updated
17/11/2021
Titles & IDs
Public title
Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced Tumors
Query!
Scientific title
A Phase 1A/1B, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Subjects With Advanced Tumors
Query!
Secondary ID [1]
0
0
BGB-A317_Study_001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - BGB-A317
Other interventions - BGB-A317
Experimental: BGB-A317 Phase 1A -
Experimental: BGB-A317 Phase 1B -
Other interventions: BGB-A317
In the dose escalation part, the dose levels were escalated following a modified 3+3 dose escalation scheme. In the scheduled exploration part, participants were assigned to doses and dose schedules. In the fixed dose exploration part, participants were assigned to dose group(s) not to exceed the maximum tolerated dose. In the dose expansion part, participants were assigned to different groups based on their tumor type.
Other interventions: BGB-A317
Participants were assigned to different groups based on their tumor types
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Phase 1A: Number of Participants Experiencing Adverse Events (AEs)
Query!
Assessment method [1]
0
0
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an investigational product. All AEs were monitored per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version [v] 4.03 2010).
Query!
Timepoint [1]
0
0
Day -28 through 5 years and 2 months
Query!
Primary outcome [2]
0
0
Phase 1A: Number Of Participants With Abnormal Physical Examination Values
Query!
Assessment method [2]
0
0
A complete physical examination, vital signs (systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate, temperature, and respiratory rate), and weight were performed pre-specified time points for Phase 1A. During the treatment period, symptom-directed physical examinations were performed. If there were no complaints and no abnormal findings from the previous visit for a particular organ system, a physical examination of that organ system was not required.
Query!
Timepoint [2]
0
0
Day 1 and Day 15 of each cycle through 30 (+/- 7) days after last dose (up to 5 years and 2 months)
Query!
Primary outcome [3]
0
0
Phase 1A: Number Of Participants Experiencing Dose-dependent Toxicity Through Ophthalmology Findings
Query!
Assessment method [3]
0
0
Ophthalmological examinations (such as eyesight/visual acuity, fundoscopy, slit lamp microscopy, and optical coherence tomography [or equivalent diagnostic test]) were performed at pre-specified time points for Phase 1A. Eye exam, visual acuity test, and optical coherence tomography (or equivalent diagnostic test) will be assessed by an appropriate specialist at Screening. Participants dosed underwent subsequent ophthalmologic examinations, a specified in the protocol, by an appropriate specialist during study treatment.
Query!
Timepoint [3]
0
0
Day 15 of cycle 1, Day 1 of Cycle 2 and all additional cycles, and 30 (+/- 7) days after last dose (up to 5 years and 2 months)
Query!
Primary outcome [4]
0
0
Phase 1A: Number Of Participants With Abnormal Electrocardiograms
Query!
Assessment method [4]
0
0
Electrocardiograms were obtained at pre-specified time points. Significant QT interval corrected for heart rate (QTc) prolongation was defined as an interval = 500 milliseconds (msec) or an interval which increases by = 60 msec over baseline.
Query!
Timepoint [4]
0
0
Days 1 and 15 of cycle 1; Day 1 of cycle 2 and all additional cycles; Day 1 of cycle 4; 30 (+/- 7) days after last dose (up to 5 years and 2 months)
Query!
Primary outcome [5]
0
0
Phase 1A: Number Of Participants With Abnormal Laboratory Values
Query!
Assessment method [5]
0
0
Clinical chemistry, hematology, coagulation, and urinalysis were performed at pre-specified time points for Phase 1A. If warranted, additional testing was done, or the relevant tests done more frequently in accordance with institutional guidelines. All participants who had any Grade 3 or Grade 4 laboratory abnormalities at withdrawal from the study were followed up until they had returned to Grade 1 or Grade 2, unless these were not likely to improve due to the underlying disease. Participants experiencing decreases (low) and increases (high) to = Grade 3 are reported.
Query!
Timepoint [5]
0
0
Day -28 (predose), Days 1, 8, and 15 of cycle 1; Days 1 and 15 of cycle 2 and additional cycles; Days 1 and 15 of cycle 4; 30 (+/- 7) days after last dose (up to 5 years and 2 months)
Query!
Primary outcome [6]
0
0
Phase 1A: Number Of Participants Experiencing Severe AEs
Query!
Assessment method [6]
0
0
All AEs were monitored per the NCI-CTCAE (v 4.03 2010). In addition to performing the CTCAE assessment, the intensity of each AE and serious adverse event (SAE) recorded was assigned to one of the following categories based on the Investigator's clinical judgment: Mild: an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate: An event that is sufficiently discomforting to interfere with normal everyday activities; severe: An event that prevents normal everyday activities. Severity was a category utilized for rating the intensity of an event and, accordingly, both AEs and SAEs could be assessed as severe.
Query!
Timepoint [6]
0
0
Day -28 through 5 years and 2 months
Query!
Primary outcome [7]
0
0
Phase 1B: Objective Response Rate (ORR)
Query!
Assessment method [7]
0
0
The ORR was defined as the percentage of participants in the study whose best overall response was either complete response (CR) or partial response (PR) as assessed by investigators based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.
Query!
Timepoint [7]
0
0
Day -28 through 5 years and 2 months
Query!
Secondary outcome [1]
0
0
Phase 1A: Area Under The Plasma Concentration-time Curve Within the Dosing Interval (AUC0-tau) For Tislelizumab
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose
Query!
Secondary outcome [2]
0
0
Phase 1A: Maximum Observed Plasma Concentration (Cmax) For Tislelizumab
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose
Query!
Secondary outcome [3]
0
0
Phase 1A: Time To Maximum Concentration (Tmax) For Tislelizumab
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose
Query!
Secondary outcome [4]
0
0
Phase 1A: Half-life (T½) For Tislelizumab
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose
Query!
Secondary outcome [5]
0
0
Phase 1A - Part 3: Clearance (Cl) For Tislelizumab
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose
Query!
Secondary outcome [6]
0
0
Phase 1A/1B: Number Of Participants With Anti-drug Antibodies (ADAs)
Query!
Assessment method [6]
0
0
Immunogenicity was summarized by the number and percentage of participants who developed detectable treatment-emergent ADAs, which included positive ADAs and neutralizing antibodies (NAb).
Query!
Timepoint [6]
0
0
Day 1 of Cycles 1 through 15
Query!
Secondary outcome [7]
0
0
Phase 1A: ORR
Query!
Assessment method [7]
0
0
The ORR was defined as the percentage of participants in the study whose best overall response was either CR or PR as assessed by investigators based on RECIST v 1.1.
Query!
Timepoint [7]
0
0
Day -28 through 5 years and 2 months
Query!
Secondary outcome [8]
0
0
Phase 1A: CR Rate
Query!
Assessment method [8]
0
0
The CR rate was based on RECIST v 1.1 and the results of Investigator evaluations.
Query!
Timepoint [8]
0
0
Day -28 through 5 years and 2 months
Query!
Secondary outcome [9]
0
0
Phase 1A: PR Rate
Query!
Assessment method [9]
0
0
The PR rate was based on RECIST v 1.1 and the results of Investigator evaluations.
Query!
Timepoint [9]
0
0
Day -28 through 5 years and 2 months
Query!
Secondary outcome [10]
0
0
Phase 1A: Stable Disease (SD) Rate
Query!
Assessment method [10]
0
0
The SD rate was based on RECIST v 1.1 and the results of Investigator evaluations.
Query!
Timepoint [10]
0
0
Day -28 through 5 years and 2 months
Query!
Secondary outcome [11]
0
0
Phase 1A: Progression-free Survival (PFS)
Query!
Assessment method [11]
0
0
PFS was defined as the time from the date of first study dose to disease progression or death whichever occurs first. Participants without an event (no disease progression or death) were censored at the date of "last tumor assessment". Participants with no baseline or post-baseline tumor assessments were censored at Day 1. PFS was based on RECIST v 1.1 and the results of Investigator evaluations.
Query!
Timepoint [11]
0
0
Day -28 through 5 years and 2 months
Query!
Secondary outcome [12]
0
0
Phase 1A: Overall Survival (OS)
Query!
Assessment method [12]
0
0
OS was defined as the time interval between the date of the first study drug dose to the date of death for any cause. Kaplan-Meier methodology was used to estimate OS at various time points. The OS was based on RECIST v 1.1 and the results of Investigator evaluations.
Query!
Timepoint [12]
0
0
Day -28 through 5 years and 2 months
Query!
Secondary outcome [13]
0
0
Phase 1A: Duration Of Response (DOR)
Query!
Assessment method [13]
0
0
DOR for responders (CR or PR) was defined as the time interval between the date of the earliest qualifying response and the date of progressive disease or death for any cause, whichever occurred earlier. For participants who were alive without progression following the qualifying response, DOR was censored on the date of last evaluable tumor assessment or last follow-up for progression of disease. The DOR was based on RECIST v 1.1 and the results of Investigator evaluations.
Query!
Timepoint [13]
0
0
Day -28 through 5 years and 2 months
Query!
Secondary outcome [14]
0
0
Phase 1B: Number of Participants Experiencing AEs
Query!
Assessment method [14]
0
0
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an investigational product. All AEs were monitored per the NCI-CTCAE (v 4.03 2010).
Query!
Timepoint [14]
0
0
Day -28 through 5 years and 2 months
Query!
Secondary outcome [15]
0
0
Phase 1B: Steady State Plasma Trough Concentration Of Tislelizumab
Query!
Assessment method [15]
0
0
Query!
Timepoint [15]
0
0
Pre-dose, Day 1 Cycle 5 and every other Cycle in the first 6 months, every 4 cycles in the next 6 months, once every 6 months up to end of treatment (up to 5 years and 2 months)
Query!
Secondary outcome [16]
0
0
Phase 1B: PFS
Query!
Assessment method [16]
0
0
PFS was defined as the time from the date of first study dose to disease progression or death whichever occurs first. Participants without an event (no disease progression or death) were censored at the date of "last tumor assessment". Participants with no baseline or post-baseline tumor assessments were censored at Day 1. PFS was based on RECIST v 1.1 and the results of Investigator evaluations.
Query!
Timepoint [16]
0
0
Day -28 through 5 years and 2 months
Query!
Secondary outcome [17]
0
0
Phase 1B: Disease Control Rate (DCR)
Query!
Assessment method [17]
0
0
The DCR was defined as the percentage of participants who achieve CR, PR, and SD based on RECIST v 1.1 in participants with select tumor types.
Query!
Timepoint [17]
0
0
Day -28 through 5 years and 2 months
Query!
Secondary outcome [18]
0
0
Phase 1B: Clinical Benefit Rate (CBR)
Query!
Assessment method [18]
0
0
The CBR was defined as the percentage of participants who achieved CR, PR, and durable SD [SD =24 weeks] based on RECIST v 1.1 in participants with select tumor types.
Query!
Timepoint [18]
0
0
Day -28 through 5 years and 2 months
Query!
Secondary outcome [19]
0
0
Phase 1B: Number Of Participants With Abnormal Physical Examination Values
Query!
Assessment method [19]
0
0
A complete physical examination, vital signs (SBP, DBP, pulse rate, temperature, and respiratory rate), and weight were performed pre-specified time points for Phase 1B. During the treatment period, symptom-directed physical examinations were performed. If there were no complaints and no abnormal findings from the previous visit for a particular organ system, a physical examination of that organ system was not required.
Query!
Timepoint [19]
0
0
Day -28 (predose), Days 1, 4, 8, and 15 of cycle 1; Day 1 of cycle 2; through 30 (+/- 7) days after last dose up to 5 years and 2 months
Query!
Secondary outcome [20]
0
0
Phase 1B: Number Of Participants Experiencing Dose-dependent Toxicity Through Ophthalmology Findings
Query!
Assessment method [20]
0
0
Ophthalmological examinations (such as eyesight/visual acuity, fundoscopy, slit lamp microscopy, and optical coherence tomography [or equivalent diagnostic test]) were performed at pre-specified time points for Phase 1B. Eye exam, visual acuity test, and optical coherence tomography (or equivalent diagnostic test) will be assessed by an appropriate specialist at Screening. Participants dosed underwent subsequent ophthalmologic examinations, a specified in the protocol, by an appropriate specialist during study treatment.
Query!
Timepoint [20]
0
0
Day -28 (predose), Day 1 of cycle 2 and additional cycles, and 30 (+/- 7) days after last dose up to 5 years and 2 months
Query!
Secondary outcome [21]
0
0
Phase 1B: Number Of Participants With Abnormal Electrocardiograms
Query!
Assessment method [21]
0
0
Electrocardiograms were obtained at pre-specified time points. Significant QTc prolongation was defined as an interval = 500 msec or an interval which increases by = 60 msec over baseline.
Query!
Timepoint [21]
0
0
Day -28 (predose), Days 1 and 15 of cycle 1; Day 1 of cycle 2 and additional cycles; 30 (+/- 7) days after last dose up to 5 years and 2 months
Query!
Secondary outcome [22]
0
0
Phase 1B: Number Of Participants With Abnormal Laboratory Values
Query!
Assessment method [22]
0
0
Clinical chemistry, hematology, coagulation, and urinalysis will be performed at pre-specified time points for Phase 1A and Phase 1B respectively. If warranted, additional testing was done, or the relevant tests done more frequently in accordance with institutional guidelines. All participants who had any Grade 3 or Grade 4 laboratory abnormalities at withdrawal from the study were followed up until they had returned to Grade 1 or Grade 2, unless these were not likely to improve due to the underlying disease. Participants experiencing decreases (low) and increases (high) to = Grade 3 are reported.
Query!
Timepoint [22]
0
0
Day -28 (predose), Days 1, 8, and 15 of cycle 1; Day 1 of cycle 2 and additional cycles; 30 (+/- 7) days after last dose up to 5 years and 2 months
Query!
Secondary outcome [23]
0
0
Phase 1B: Number Of Participants Experiencing Severe AEs
Query!
Assessment method [23]
0
0
All AEs were monitored per the NCI-CTCAE (v 4.03 2010). In addition to performing the CTCAE assessment, the intensity of each AE and SAE recorded was assigned to one of the following categories based on the Investigator's clinical judgment: Mild: an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate: An event that is sufficiently discomforting to interfere with normal everyday activities; severe: An event that prevents normal everyday activities. Severity was a category utilized for rating the intensity of an event and, accordingly, both AEs and SAEs could be assessed as severe.
Query!
Timepoint [23]
0
0
Day -28 through 5 years and 2 months
Query!
Eligibility
Key inclusion criteria
Key
1. Participants must have had a histologically or cytologically confirmed advanced or
metastatic tumor for which no effective standard therapy was available.
1. For Phase 1A: no specific restriction
2. For Phase 1B: histology specified below:
i. non-small cell lung cancer (participants with documented epidermal growth factor
receptor mutation or anaplastic lymphoma kinase rearrangement should have been
excluded) ii. ovarian cancer iii. gastric cancer iv. hepatocellular carcinoma (HCC,
Barcelona-Clinic Liver Cancer stage C, stage B not amenable to locoregional therapy or
refractory to locoregional therapy, and not amenable to a curative treatment approach,
and Child-Pugh A) v. head and neck squamous cell carcinoma vi. esophageal carcinoma
vii. triple negative breast cancer viii. cholangiocarcinoma ix. renal cell cancer,
bladder cancer, melanoma, Merkel-cell carcinoma, sarcoma, gastrointestinal stromal
tumor, or cutaneous squamous cell carcinoma. Or any other solid tumors with known
microsatellite instability-high or mismatch repair deficient status, such as
colorectal cancer or pancreatic cancer
2. Participants with previously treated brain metastasis (es) that were asymptomatic or
radiographically/clinically stable and not requiring steroids medications for 4 weeks
prior to enrollment were permitted.
3. Participants must have had archival tumor tissues or agreed to a tumor biopsy for
analysis of predictive biomarkers such as programmed death-ligand 1 (PD-L1). (Fresh
tumor biopsies were strongly recommended at baseline for biomarker analysis in
participants with readily accessible tumor lesions and who consented to the biopsies).
4. Participants must have had measurable disease as defined per Response Evaluation
Criteria in Solid Tumor Version 1.1.
5. Eastern Cooperative Oncology Group performance status of = 1.
6. Participants must have had adequate organ function as indicated by the following
laboratory values:
- Absolute neutrophil count = 1,500 /microliter
- Platelets = 100,000 / milliliter (mL)
- Hemoglobin = 9 grams/deciliter or = 5.6 millimoles/liter
- Serum creatinine = 1.5 X upper limit of normal (ULN)
- Serum total bilirubin = 1.5 X ULN
- Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine
aminotransferase (serum glutamic pyruvic transaminase) = 2.5 X ULN or = 5 X ULN
for participants with liver metastases
- International normalized ratio or prothrombin time = 1.5 X ULN
- Activated partial thromboplastin time = 1.5 X ULN
Key
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. History of severe hypersensitivity reactions to other Monoclonal antibodies.
2. Prior malignancy active within the previous 2 years except for tumor for which a
participant was enrolled in the study, and locally curable cancers that had been
apparently cured, such as basal or squamous cell skin cancer, superficial bladder
cancer or carcinoma in situ of the cervix or breast.
3. Prior therapies targeting PD-1 or PD-L1.
4. Participants who failed to meet enrollment criteria for other PD-1 or PD-L1 trials
solely due to low or negative predictive biomarkers.
5. Participants with active autoimmune diseases or history of autoimmune diseases should
have been excluded.
6. Participants should have been excluded if they had a condition requiring systemic
treatment with either corticosteroids (> 10 milligrams daily prednisone equivalents)
or other immunosuppressive medications within 14 days of study drug administration.
7. Had history of interstitial lung disease or non-infectious pneumonitis except for
those induced by radiation therapies.
8. Known history of human immunodeficiency virus.
9. Active infection requiring therapy, positive tests for hepatitis B surface antigen or
hepatitis C ribonucleic acid except in participant with HCC, who met the following
criteria:
- Hepatitis B virus (HBV) viral load < 200 international units/mL (approximately
1000 combined positive score/mL)
- Participants with active HBV infection needed to be on anti-HBV suppression = 3
months, throughout treatment and for 6 months after
- Participants hepatitis C virus (HCV)-positive after successful treatment (defined
as sustained virologic response [SVR] 12 or SVR 24) were allowed as long as 4
weeks had passed between completion of HCV therapy and start of study drug
10. Use of any vaccines against infectious diseases (for example, influenza, varicella)
within 4 weeks (28 days) of initiation of study therapy and 60 days after the last
administration of the study medication.
Note: Other protocol defined Inclusion/Exclusion criteria may have applied.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
2/06/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
12/08/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
451
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Chris O'Brien Lifehouse - Camperdown
Query!
Recruitment hospital [2]
0
0
Prince of Wales Hospital - Sydney
Query!
Recruitment hospital [3]
0
0
Tasman Oncology Research Ltd - Southport
Query!
Recruitment hospital [4]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [5]
0
0
Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [6]
0
0
The Queen Elizabeth Hospital - Woodville South
Query!
Recruitment hospital [7]
0
0
Monash Health - Clayton
Query!
Recruitment hospital [8]
0
0
Peter MacCallum Cancer Centre - East Melbourne
Query!
Recruitment hospital [9]
0
0
Austin Health Hospital - Heidelberg
Query!
Recruitment hospital [10]
0
0
Cabrini Hospital - Malvern
Query!
Recruitment hospital [11]
0
0
Nucleus Network - Melbourne
Query!
Recruitment hospital [12]
0
0
Royal Melbourne Hospital - Melbourne
Query!
Recruitment hospital [13]
0
0
Linear Clinical Research/Sir Charles Gairdner Hospital - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
- Sydney
Query!
Recruitment postcode(s) [3]
0
0
4216 - Southport
Query!
Recruitment postcode(s) [4]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [5]
0
0
- Adelaide
Query!
Recruitment postcode(s) [6]
0
0
- Woodville South
Query!
Recruitment postcode(s) [7]
0
0
- Clayton
Query!
Recruitment postcode(s) [8]
0
0
- East Melbourne
Query!
Recruitment postcode(s) [9]
0
0
- Heidelberg
Query!
Recruitment postcode(s) [10]
0
0
3144 - Malvern
Query!
Recruitment postcode(s) [11]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [12]
0
0
- Melbourne
Query!
Recruitment postcode(s) [13]
0
0
- Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Massachusetts
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Texas
Query!
Country [3]
0
0
Korea, Republic of
Query!
State/province [3]
0
0
Kyeonggi-do
Query!
Country [4]
0
0
Korea, Republic of
Query!
State/province [4]
0
0
Seoul
Query!
Country [5]
0
0
New Zealand
Query!
State/province [5]
0
0
Grafton
Query!
Country [6]
0
0
New Zealand
Query!
State/province [6]
0
0
Hamilton
Query!
Country [7]
0
0
New Zealand
Query!
State/province [7]
0
0
Wellington
Query!
Country [8]
0
0
Taiwan
Query!
State/province [8]
0
0
Kaohsiung
Query!
Country [9]
0
0
Taiwan
Query!
State/province [9]
0
0
Tainan
Query!
Country [10]
0
0
Taiwan
Query!
State/province [10]
0
0
Taipei
Query!
Country [11]
0
0
Taiwan
Query!
State/province [11]
0
0
Taoyuan
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
BeiGene
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study evaluated the safety, tolerability, pharmacokinetic profile and treatment effect
of a new drug known as BGB-A317 in participants with advanced tumors.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02407990
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Study Director
Query!
Address
0
0
BeiGene
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02407990
Download to PDF