Solid TumorsPhase 1NCT03641586

The Study of BGB-283 in Chinese Subjects With Local Advanced or Metastatic Malignant Solid Tumor

A Phase 1 study testing BGB-283 in people with Solid Tumors, run by BeiGene at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will evaluate the safety, tolerability, pharmacokinetics, food effect, and preliminary antitumor activities of BGB-283 in Chinese subjects with local advanced or metastatic malignant solid tumor. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Solid Tumors
What is being tested?: BGB-283
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteChina
Study dates: 12 Oct 2015to 7 Mar 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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provided written informed consent prior to enrollment.
Male or female and between 18 and 75 years old.
A life expectancy of more than 12 weeks.
Stage I and III: Histologically or cytologically confirmed advanced or metastatic solid tumor for which no effective standard therapy is available. We simultaneously require patients with one of B-RAF, N-RAS, or K-RAS mutation positive solid tumor.
In Stage II: we require advanced or metastatic melanoma with the B-RAF mutation.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.

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Able to swallow and retain oral medication.
Adequate bone marrow, liver, and renal function:
Hemoglobin > 90 g/L
Absolute neutrophil count ≥ 1.5x10^9/L
Platelets ≥ 100 x10^9/L
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 ≥ 50 mL/min (calculated by the Cockcroft Gault formula).

Who cannot join

Female subjects who are pregnant or lactating.
Prior chemotherapy, radiotherapy, immunotherapy or any investigational therapies used to control cancer must have been completed at least 4 weeks or at least 5 half-lives (whichever is shorter before study drug administration, but at least 21 days)
Any major surgery within 28 days prior to enrollment.
Any radiotherapy for metastatic foci within 14 days prior to enrollment,
Unresolved toxicity > Grade 1 (according to NCI-CTCAE, Version 4.03) from previous anti cancer therapy.
History or presence of gastrointestinal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
Any clinical significant active infection that need systematic treatment, including HIV positive subjects, or known Hepatitis B or C.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: A Phase I, Single and Multiple Dose Escalation/Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Food Effect, and Preliminary Antitumor Activities of BGB-283 in Chinese Subjects With Local Advanced or Metastatic Malignant Solid Tumor

Read the detailed description

"This study is conducted on the basis of the completed multi-dose, dose escalation, Phase IA trial in Australia, is a dose-finding, dose expansion and food effects study of BGB-283 capsules in Chinese patients with locally advanced or metastatic solid tumor to determine the tolerability, safety, pharmacokinetic profiles, preliminary efficacy, food effects under high-fat meal on the absorption and metabolism of BGB-283, and preliminary anti-tumor efficacy.

The study was conducted in three phases: Stage I for dose escalation, Stage II for dose expansion and Stage III for food effects on pharmacokinetics under high fat meal.

Stage I Dose escalation: In a open-label, dose-escalation design, dose escalation will be performed with the '3 + 3' scheme and the dosage levels of BGB-283 capsules will be gradually increased.

Stage II Dose expansion: 20 mg/qd and 30 mg/qd are considered as effective and safe doses, based on preliminary results from Phase IA clinical studies in Australia. To further understand the preliminary pharmacodynamic results of BGB-283 in Chinese patients with malignant melanoma, 20mg/qd dose expansion study in B-RAF mutated malignant melanoma will be further explored if it has been proved to be a safe dose in Chinese population according to the '3 + 3' scheme.

Stage III uses multi-center, open, two-group crossover self-control design to compare the high-fat meal effect on pharmacokinetics."

Conditions: Solid Tumors
Being tested: BGB-283
Keywords: Dose Escalation, Dose Expansion, BGB-283

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BGB-283Drug

Study groups in NCT03641586
Study group	Role	What they receive
Stage I	Experimental	Approximately 25-35 Chinese subjects with local advanced or metastatic malignant solid tumor will be enrolled in the dose escalation stage of BGB-283 until maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) determination Receives: Drug: BGB-283
Stage II	Experimental	Approximately 15-30 melanoma subjects will be enrolled in dose expansion stage of BGB-283 Receives: Drug: BGB-283
Stage III	Experimental	20 subjects will be enrolled for food effect stage of BGB-283 Receives: Drug: BGB-283

What is being measured

The primary outcome is the main question the study is designed to answer.

Stage 1: Number of participants with treatment-related adverse events as assessed by CTC AE 4.03, 1 year in average
Measured: From signing the informed consent form and throughout the study, 1 year in average
Stage 2: To determine the objective response rate (ORR) as assessed by RECIST, Version 1.1
Measured: Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, 1 year in average
Stage 3: Area under the plasma concentration-time curve from time 0 to infinity time (AUC)
Measured: Within 43 days since first dose
Stage 3: Maximum plasma concentration (Cmax)
Measured: Within 43 days since first dose
Stage 3: Terminal elimination half-life (t1/2)
Measured: Within 43 days since first dose
Stage 3: Detect Ka for Pop-PK analysis
Measured: Within 43 days since first dose
Stage 3: Detect CL/F for Pop-PK analysis
Measured: Within 43 days since first dose
Stage 3: Detect Vc/F for Pop-PK analysis
Measured: Within 43 days since first dose

Secondary outcomes (6)

Stage 1: Area under the plasma concentration-time curve from time 0 to infinity time (AUC)
Measured: Within 43 days since first dose
Stage 1: Maximum plasma concentration (Cmax)
Measured: Within 43 days since first dose
Stage 1: Terminal elimination half-life (t1/2)
Measured: Within 43 days since first dose
Stage 1: To determine the objective response rate (ORR) as assessed by RECIST, Version 1.1
Measured: Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, 1 year in average
Stage 2: Number of participants with treatment-related adverse events as assessed by CTC AE 4.03, 1 year in average
Measured: From signing the informed consent form and throughout the study, 1 year in average
Stage 3: To determine the objective response rate (ORR) as assessed by RECIST, Version 1.1
Measured: Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, 1 year in average

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 20157 Mar 2019

First posted22 Aug 2018
Study start12 Oct 2015
Primary completion6 Dec 2016
Study completion7 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumorsStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03641586
Sponsor's protocol ID: BGB-283-CN-001
Other IDs: CTR20150575
Status last verified: Oct 2024
First submitted: 11 Jul 2018
Last updated: 23 Oct 2024
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Single and Multiple Dose Escalation/Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Food Effect, and Preliminary Antitumor Activities of BGB-283 in Chinese Subjects With Local Advanced or Metastatic Malignant Solid Tumor
ClinicalTrials.gov ID: NCT03641586
Acronym / sponsor ID: BGB-283-CN-001
Conditions: Solid Tumors
Keywords: Dose Escalation, Dose Expansion, BGB-283
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: BeiGeneIndustry (pharma, biotech, devices)
Study start: 12 Oct 2015 (actual)
Primary completion: 6 Dec 2016 (actual)
Study completion: 7 Mar 2019 (actual)
First posted: 22 Aug 2018 (actual)
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.

Detailed description

The study was conducted in three phases: Stage I for dose escalation, Stage II for dose expansion and Stage III for food effects on pharmacokinetics under high fat meal.

Stage I Dose escalation: In a open-label, dose-escalation design, dose escalation will be performed with the '3 + 3' scheme and the dosage levels of BGB-283 capsules will be gradually increased.

Stage III uses multi-center, open, two-group crossover self-control design to compare the high-fat meal effect on pharmacokinetics."

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Stage I	Experimental	Drug: BGB-283Approximately 25-35 Chinese subjects with local advanced or metastatic malignant solid tumor will be enrolled in the dose escalation stage of BGB-283 until maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) determination
Stage II	Experimental	Drug: BGB-283Approximately 15-30 melanoma subjects will be enrolled in dose expansion stage of BGB-283
Stage III	Experimental	Drug: BGB-28320 subjects will be enrolled for food effect stage of BGB-283

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Provided written informed consent prior to enrollment.
Male or female and between 18 and 75 years old.
A life expectancy of more than 12 weeks.
Stage I and III: Histologically or cytologically confirmed advanced or metastatic solid tumor for which no effective standard therapy is available. We simultaneously require patients with one of B-RAF, N-RAS, or K-RAS mutation positive solid tumor.
In Stage II: we require advanced or metastatic melanoma with the B-RAF mutation.

Key exclusion criteria (7 listed)

Female subjects who are pregnant or lactating.
Prior chemotherapy, radiotherapy, immunotherapy or any investigational therapies used to control cancer must have been completed at least 4 weeks or at least 5 half-lives (whichever is shorter before study drug administration, but at least 21 days)
Any major surgery within 28 days prior to enrollment.
Any radiotherapy for metastatic foci within 14 days prior to enrollment,
Unresolved toxicity > Grade 1 (according to NCI-CTCAE, Version 4.03) from previous anti cancer therapy.

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-283	Drug	Stage I, Stage II, Stage III

Primary outcome

Stage 1: Number of participants with treatment-related adverse events as assessed by CTC AE 4.03, 1 year in average
Time frame: From signing the informed consent form and throughout the study, 1 year in average
Stage 2: To determine the objective response rate (ORR) as assessed by RECIST, Version 1.1
Time frame: Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, 1 year in average
Stage 3: Area under the plasma concentration-time curve from time 0 to infinity time (AUC)
Time frame: Within 43 days since first dose
Stage 3: Maximum plasma concentration (Cmax)
Time frame: Within 43 days since first dose
Stage 3: Terminal elimination half-life (t1/2)
Time frame: Within 43 days since first dose
Stage 3: Detect Ka for Pop-PK analysis
Time frame: Within 43 days since first dose
Stage 3: Detect CL/F for Pop-PK analysis
Time frame: Within 43 days since first dose
Stage 3: Detect Vc/F for Pop-PK analysis
Time frame: Within 43 days since first dose

6 secondary outcomes

Stage 1: Area under the plasma concentration-time curve from time 0 to infinity time (AUC)
Time frame: Within 43 days since first dose
Stage 1: Maximum plasma concentration (Cmax)
Time frame: Within 43 days since first dose
Stage 1: Terminal elimination half-life (t1/2)
Time frame: Within 43 days since first dose
Stage 1: To determine the objective response rate (ORR) as assessed by RECIST, Version 1.1
Time frame: Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, 1 year in average
Stage 2: Number of participants with treatment-related adverse events as assessed by CTC AE 4.03, 1 year in average
Time frame: From signing the informed consent form and throughout the study, 1 year in average
Stage 3: To determine the objective response rate (ORR) as assessed by RECIST, Version 1.1
Time frame: Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, 1 year in average

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 23 Oct 2024.

Related trials for Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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.

Xiang Li, MD study director

BeiGene

1 site 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-283 in people with Solid Tumors, run by BeiGene at 1 site in China.

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 14 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 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

Stage 1: Number of participants with treatment-related adverse events as assessed by CTC AE 4.03, 1 year in average (time frame: From signing the informed consent form and throughout the study, 1 year in average). The study lists 8 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 NCT03641586.

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 23 Oct 2024.