- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02361723
Phase 1a/1b BGB-290 for Advanced Solid Tumors.
April 22, 2020 updated by: BeiGene
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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 PK of BGB 290 in participants with advanced solid tumors.
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Hamlyn Terrace, New South Wales, Australia, NSW 2559
- Gosford Hospital
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South Australia
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Bedford Park, South Australia, Australia, SA 5042
- Flinders Medical Centre
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Victoria
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Heidelberg, Victoria, Australia, VIC 3084
- Austin Health Joint Ludwig/Oncology Unit
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Melbourne, Victoria, Australia, VIC 3000
- Peter MacCallum Cancer Centre
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Melbourne, Victoria, Australia, VIC 3004
- Nucleus Network
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Western Australia
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Nedlands, Western Australia, Australia, WA 6009
- Linear Clinical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- Male or female and at least 18 years of age with a life expectancy of at least 12 weeks.
- Histologically or cytologically confirmed malignancy that has progressed to the advanced or metastatic stage for which no effective standard therapy is available.
- BRCA1/2 mutations are not required but enrichment of this participant population is permitted.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
- Adequate bone marrow, liver, and renal function.
- Participants who have histologic or cytologic confirmation of malignancy that has progressed to the advanced or metastatic stage.
- Eligible participants who have received the prior chemotherapy regimen in the advanced or metastatic setting.
- 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.
- Able to swallow and retain oral medication.
Key Exclusion Criteria:
- Participants did not receive prior therapies targeting poly-ADP ribose polymerase (PARP).
- 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).
- 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).
- Participants who have not undergone major surgery/surgical therapy for any cause within 4 weeks of screening visit.
- Participants must have recovered from the treatment and have a stable clinical condition before entering this study.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ovarian cancer, fallopian cancer, or primary peritoneal cancer
60mg BID oral.
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Experimental: Breast Cancer
60mg BID Ora
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Experimental: Prostate Cancer
60mg BID Oral
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Experimental: Small Cell Lung Cancer
60mg BID Oral
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Experimental: Gastric Cancer
60mg BID Oral
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate ([ORR]: Complete Response (CR) + Partial Response (PR)) based on RECIST Version 1.1
Time Frame: through study completion, an average of 1 year
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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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through study completion, an average of 1 year
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Prostate-specific antigen (PSA) response (for prostate cancer participants only) based on Prostate Cancer Working Group 2 (PCWG2) criteria
Time Frame: through study completion, an average of 1 year
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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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through study completion, an average of 1 year
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Primary PK 1
Time Frame: through study completion, an average of 1 year
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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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through study completion, an average of 1 year
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Primary PK 2
Time Frame: through study completion, an average of 1 year
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Primary PK parameter is area under plasma concentration time curve (AUC).
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through study completion, an average of 1 year
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Primary PK 3
Time Frame: through study completion, an average of 1 year
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Primary PK parameter is maximum observed plasma concentration (Cmax).
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through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: through study completion, an average of 1 year
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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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through study completion, an average of 1 year
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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.
Time Frame: through study completion, an average of 1 year
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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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through study completion, an average of 1 year
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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).
Time Frame: through study completion, an average of 1 year
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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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through study completion, an average of 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Millward, MD, Linear Clinical Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lickliter JD, Gan HK, Meniawy T, Yang J, Wang L, Luo LS, Millward M. A phase I dose-escalation study of BGB-290, a novel PARP1/2 selective inhibitor in patients with advanced solid tumors. Journal of Clinical Oncology. 2016; 34(15): DOI: 10.1200/JCO.2016.34.15_suppl.e17049
- Lickliter JD, Voskoboynik M, Mileshkin L, Gan HK, Kichenadasse G, Zhang K, Zhang M, Tang Z, Millward M. Phase 1A/1B dose-escalation and -expansion study to evaluate the safety, pharmacokinetics, food effects and antitumor activity of pamiparib in advanced solid tumours. Br J Cancer. 2022 Mar;126(4):576-585. doi: 10.1038/s41416-021-01632-2. Epub 2021 Nov 18. Erratum In: Br J Cancer. 2021 Dec 20;:
- Xu B, Yin Y, Dong M, Song Y, Li W, Huang X, Wang T, He J, Mu X, Li L, Mu S, Zhang W, Li M. Pamiparib dose escalation in Chinese patients with non-mucinous high-grade ovarian cancer or advanced triple-negative breast cancer. Cancer Med. 2021 Jan;10(1):109-118. doi: 10.1002/cam4.3575. Epub 2020 Oct 31.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 3, 2014
Primary Completion (Actual)
September 3, 2019
Study Completion (Actual)
September 3, 2019
Study Registration Dates
First Submitted
January 29, 2015
First Submitted That Met QC Criteria
February 8, 2015
First Posted (Estimate)
February 12, 2015
Study Record Updates
Last Update Posted (Actual)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 22, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BGB-290-AU-002
- 2017-003646-25 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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