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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/NCT02361723
Registration number
NCT02361723
Ethics application status
Date submitted
29/01/2015
Date registered
12/02/2015
Date last updated
24/04/2020
Titles & IDs
Public title
Phase 1a/1b BGB-290 for Advanced Solid Tumors.
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Scientific title
A Phase 1A/1B, Open Label, Multiple Dose, Dose Escalation, and Expansion Study to Investigate the Safety, Pharmacokinetics, Food Effect, and Antitumor Activities of BGB-290 in Subjects With Advanced Solid Tumors
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Secondary ID [1]
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2017-003646-25
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Secondary ID [2]
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BGB-290-AU-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
For Participants With Advanced Solid Tumors Failed With Previous Lines of Treatment
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BGB-290
Treatment: Drugs - BGB-290
Treatment: Drugs - BGB-290
Treatment: Drugs - BGB-290
Treatment: Drugs - BGB-290
Experimental: ovarian cancer, fallopian cancer, or primary peritoneal cancer - 60mg BID oral.
Experimental: Breast Cancer - 60mg BID Ora
Experimental: Prostate Cancer - 60mg BID Oral
Experimental: Small Cell Lung Cancer - 60mg BID Oral
Experimental: Gastric Cancer - 60mg BID Oral
Treatment: Drugs: BGB-290
Treatment: Drugs: BGB-290
Treatment: Drugs: BGB-290
Treatment: Drugs: BGB-290
Treatment: Drugs: BGB-290
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective response rate ([ORR]: Complete Response (CR) + Partial Response (PR)) based on RECIST Version 1.1
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Assessment method [1]
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The primary endpoint of the study was a composite response rate that included ORR, a =50% decrease in serum prostate-specific antigen (PSA), and/or a decrease in circulating tumor cells.
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Timepoint [1]
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through study completion, an average of 1 year
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Primary outcome [2]
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Prostate-specific antigen (PSA) response (for prostate cancer participants only) based on Prostate Cancer Working Group 2 (PCWG2) criteria
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Assessment method [2]
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The primary endpoint of the study was a composite response rate that included ORR, a =50% decrease in serum prostate-specific antigen (PSA), and/or a decrease in circulating tumor cells.
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Timepoint [2]
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through study completion, an average of 1 year
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Primary outcome [3]
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Primary PK 1
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Assessment method [3]
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Primary PK parameter is area under the plasma concentration time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUClast).
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Timepoint [3]
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through study completion, an average of 1 year
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Primary outcome [4]
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Primary PK 2
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Assessment method [4]
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Primary PK parameter is area under plasma concentration time curve (AUC).
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Timepoint [4]
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through study completion, an average of 1 year
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Primary outcome [5]
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Primary PK 3
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Assessment method [5]
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Primary PK parameter is maximum observed plasma concentration (Cmax).
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Timepoint [5]
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through study completion, an average of 1 year
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Secondary outcome [1]
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Progression free survival
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Assessment method [1]
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Participants, who are withdrawn from the study without documented progression, will be censored at the date of the last tumor assessment when the participant was known to be progression free. Participants without post screening tumor assessments, but known to be alive will be censored at the time of the first administration of BGB 290).
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Timepoint [1]
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through study completion, an average of 1 year
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Secondary outcome [2]
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Duration of response for responders (CR or PR) and duration of SD (defined only for participants whose confirmed best response is CR, PR, or SD.
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Assessment method [2]
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For participants who are alive without progression following the qualifying response, duration of response will be censored on the date of last evaluable tumor assessment or last follow up for progression of disease).
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Timepoint [2]
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through study completion, an average of 1 year
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Secondary outcome [3]
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The number and proportion of participants who achieve objective tumor response (complete response [CR], partial response [PR], and CR+PR) or stable disease (SD).
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Assessment method [3]
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For ovarian cancer participants, tumor responses may also be evaluated using RECIST Version 1.1 combined with CA-125 based on the Gynecologic Cancer Intergroup (GCIG) criteria. For participants with prostate cancer, PCWG2 criteria may be used to evaluate responses by investigators.
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Timepoint [3]
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through study completion, an average of 1 year
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Eligibility
Key inclusion criteria
Key
1. Male or female and at least 18 years of age with a life expectancy of at least 12
weeks.
2. Histologically or cytologically confirmed malignancy that has progressed to the
advanced or metastatic stage for which no effective standard therapy is available.
3. BRCA1/2 mutations are not required but enrichment of this participant population is
permitted.
4. Eastern Cooperative Oncology Group (ECOG) performance status of = 1.
5. Adequate bone marrow, liver, and renal function.
6. Participants who have histologic or cytologic confirmation of malignancy that has
progressed to the advanced or metastatic stage.
7. Eligible participants who have received the prior chemotherapy regimen in the advanced
or metastatic setting.
8. Females of childbearing potential unwilling to use a highly effective method of
contraception during treatment and throughout the study until 28 days after the last
investigational product administration.
9. Able to swallow and retain oral medication.
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Participants did not receive prior therapies targeting poly-ADP ribose polymerase
(PARP).
2. Participants who are not considered to be refractory to platinum-based therapy (e.g.,
progressive disease at the first tumor assessment while receiving platinum treatment).
3. Participants who have not been treated with chemotherapy, biologic therapy,
immunotherapy, or other investigational agent within five times half-lives of the last
treatment or within 4 weeks (whichever is longer) prior to starting study drug (or who
have not recovered from the side effects of such therapy).
4. Participants who have not undergone major surgery/surgical therapy for any cause
within 4 weeks of screening visit.
5. Participants must have recovered from the treatment and have a stable clinical
condition before entering this study.
6. Participants who have not received therapeutic radiotherapy to target lesions.
7.Participants who have received local palliative radiotherapy of non-target lesions
for local symptom control within the last 21 days must have recovered from any adverse
effects of radiotherapy before recording screening symptoms. 8.No untreated brain
metastasis or unstable neurologic condition after the completion of radiation, or
requiring corticosteroid of > 40 mg prednisone daily equivalent dose to control the
symptoms.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/07/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/09/2019
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Sample size
Target
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Accrual to date
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Final
101
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Gosford Hospital - Hamlyn Terrace
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Recruitment hospital [2]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [3]
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Austin Health Joint Ludwig/Oncology Unit - Heidelberg
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [5]
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Nucleus Network - Melbourne
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Recruitment hospital [6]
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Linear Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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NSW 2559 - Hamlyn Terrace
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Recruitment postcode(s) [2]
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SA 5042 - Bedford Park
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Recruitment postcode(s) [3]
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VIC 3084 - Heidelberg
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Recruitment postcode(s) [4]
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VIC 3000 - Melbourne
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Recruitment postcode(s) [5]
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VIC 3004 - Melbourne
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Recruitment postcode(s) [6]
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WA 6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
BeiGene
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The study contains Phase 1A and Phase 1B. Phase 1A has Part1 (BID Dose Escalation) and Part2
(QD Dosing Escalation) Evaluation of a cohort of at least three participants completing one
cycle of treatment at that dose level and dose regimen is required prior to determining the
next dose level and dose regimen for the next cohort. Phase 1B has PartA (BID Dosing
Expansion) will investigate efficacy in participants with selected tumor types and further
evaluate safety and tolerability of BGB 290 at recommended dose for future studies. and PartB
(Food Effect) will investigate the food effect on the Pharmacokinetics (PK) of BGB 290 in
participants with advanced solid tumors.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02361723
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michael Millward, MD
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Address
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Linear Clinical Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02361723
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