For Participants With Advanced Solid Tumors Failed With Previous Lines of TreatmentPhase 1NCT02361723
Phase 1a/1b BGB-290 for Advanced Solid Tumors.
A Phase 1 study testing BGB-290 in people with For Participants With Advanced Solid Tumors Failed With Previous Lines of Treatment, run by BeiGene at 7 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- For Participants With Advanced Solid Tumors Failed With Previous Lines of Treatment
- What is being tested?
- BGB-290
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 7 sitesAustralia
- Study dates
- 3 Jul 2014to 3 Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Australia7 sites
Flinders Medical Centre
Bedford PK, South Australia, 5042
Gosford Hospital
Gosford, New South Wales, 2250
Austin Health
Heidelberg, Victoria, 3084
Peter Maccallum Cancer Centre
Melbourne, Victoria, 3000
Nucleus Network
Melbourne, Victoria, 3004
Linear Clinical Research
Nedlands, Western Australia, 6009
Cancer Care Wollongong
Wollongong, New South Wales, 2500
About this study
Official 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
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.
Read the 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.
- Being tested
- BGB-290
- Keywords
- Advanced Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-290Drug
BGB-290Drug
BGB-290Drug
BGB-290Drug
BGB-290Drug
| Study group | Role | What they receive |
|---|---|---|
| ovarian cancer, fallopian cancer, or primary peritoneal cancer | Experimental | 60mg BID oral. Receives: Drug: BGB-290 |
| Breast Cancer | Experimental | 60mg BID Ora Receives: Drug: BGB-290 |
| Prostate Cancer | Experimental | 60mg BID Oral Receives: Drug: BGB-290 |
| Small Cell Lung Cancer | Experimental | 60mg BID Oral Receives: Drug: BGB-290 |
| Gastric Cancer | Experimental | 60mg BID Oral Receives: Drug: BGB-290 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate ([ORR]: Complete Response (CR) + Partial Response (PR)) based on RECIST Version 1.1
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.
Measured: through study completion, an average of 1 year
Prostate-specific antigen (PSA) response (for prostate cancer participants only) based on Prostate Cancer Working Group 2 (PCWG2) criteria
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.
Measured: through study completion, an average of 1 year
Primary PK 1
Primary PK parameter is area under the plasma concentration time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUClast).
Measured: through study completion, an average of 1 year
Primary PK 2
Primary PK parameter is area under plasma concentration time curve (AUC).
Measured: through study completion, an average of 1 year
Primary PK 3
Primary PK parameter is maximum observed plasma concentration (Cmax).
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Progression free survival
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).
Measured: through study completion, an average of 1 year
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.
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).
Measured: through study completion, an average of 1 year
The number and proportion of participants who achieve objective tumor response (complete response [CR], partial response [PR], and CR+PR) or stable disease (SD).
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study start3 Jul 2014
- Primary completion3 Sep 2019
- Study completion3 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for For Participants With Advanced Solid Tumors Failed With Previous Lines of TreatmentStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Millward, MD, Principal investigator, Linear Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361723
- Sponsor's protocol ID
- BGB-290-AU-002
- Status last verified
- Oct 2024
- First submitted
- 29 Jan 2015
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 34795408Xu 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.
PubMed 33128299
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02361723
- Acronym / sponsor ID
- BGB-290-AU-002
- Keywords
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2014 (actual)
- Primary completion
- 3 Sep 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 12 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ovarian cancer, fallopian cancer, or primary peritoneal cancer | Experimental | Drug: BGB-29060mg BID oral. |
| Breast Cancer | Experimental | Drug: BGB-29060mg BID Ora |
| Prostate Cancer | Experimental | Drug: BGB-29060mg BID Oral |
| Small Cell Lung Cancer | Experimental | Drug: BGB-29060mg BID Oral |
| Gastric Cancer | Experimental | Drug: BGB-29060mg BID Oral |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGB-290 | Drug | ovarian cancer, fallopian cancer, or primary peritoneal cancer |
| BGB-290 | Drug | Breast Cancer |
| BGB-290 | Drug | Prostate Cancer |
| BGB-290 | Drug | Small Cell Lung Cancer |
| BGB-290 | Drug | Gastric Cancer |
Primary outcome
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
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.
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
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.
Primary PK 1
Time frame: through study completion, an average of 1 year
Primary PK parameter is area under the plasma concentration time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUClast).
Primary PK 2
Time frame: through study completion, an average of 1 year
Primary PK parameter is area under plasma concentration time curve (AUC).
Primary PK 3
Time frame: through study completion, an average of 1 year
Primary PK parameter is maximum observed plasma concentration (Cmax).
3 secondary outcomes
Progression free survival
Time frame: through study completion, an average of 1 year
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Results publicationLickliter 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
- Derived from this study: PubMed 34795408Lickliter 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.
- Derived from this study: PubMed 33128299Xu 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.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Millward, MD principal investigator
Linear Clinical Research
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGB-290 in people with For Participants With Advanced Solid Tumors Failed With Previous Lines of Treatment, run by BeiGene at 7 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02361723, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.