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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001156-36 | EudraCT Number |
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This is an open-label study, in participants with advanced and/or metastatic solid tumors, which consists of 2 parts: a research phase (inpatient) and a treatment phase. The research phase (Part 1) of the study will assess the disposition of a single oral dose of [14C]-pamiparib. In the treatment phase (Part 2) participants will be allowed to have continued access to pamiparib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pamiparib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-pamiparib | Drug | During the treatment phase, pamiparib 60 mg administered orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Pamiparib Pharmacokinetics: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 | |
| Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to Infinity (AUC0-∞) | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 | |
| Plasma Pamiparib Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t) | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 | |
| Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC-t) | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 | |
| Plasma Pamiparib Pharmacokinetics: Maximum Observed Concentration (Cmax) of Pamiparib | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 | |
| Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Maximum Observed Concentration (Cmax) | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 | |
| Plasma Pamiparib Pharmacokinetics: Time of Cmax (Tmax) | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events in Part1 and Part 2 | Up to 6 months | |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Up to 6 months | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Clatterbridge Cancer Centre NHS Foundation Trust | Bebington | Wirral | CH63 4JY | United Kingdom | ||
| Royal Liverpool University Hospital Clinical Research Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33876576 | Derived | Mu S, Palmer D, Fitzgerald R, Andreu-Vieyra C, Zhang H, Tang Z, Su D, Sahasranaman S. Human Mass Balance and Metabolite Profiling of [14 C]-Pamiparib, a Poly (ADP-Ribose) Polymerase Inhibitor, in Patients With Advanced Cancer. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1108-1120. doi: 10.1002/cpdd.943. Epub 2021 Apr 19. |
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Potential participants were screened to assess their eligibility to enter the study within 28 days prior to administration of the first dose. Up to 10 participants could be enrolled to ensure that 4 participants completed Part 1 of the study.
The study consisted of 2 parts: a Research Phase (Part 1) in which participants were inpatients and a Treatment Phase (Part 2) in which participants were outpatients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pamiparib | Research Phase (Part 1): participants received a single dose of 60 mg [14C]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pamiparib | Research Phase (Part 1): participants received a single dose of 60 mg [14C]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Pamiparib Pharmacokinetics: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) | The PK population included all participants who received one dose of [14C]-pamiparib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nanograms/milliLiter (h*ng/mL) | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
|
|
Approximately 30 days after the last dose of pamiparib - up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pamiparib | Research Phase (Part 1): participants received a single dose of 60 mg [14C]-pamiparib orally Treatment phase (Part 2): participants received 60 mg pamiparib twice daily orally |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | +1-877-828-5568 | clinicaltrials@beigene.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 12, 2018 | Aug 2, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 14, 2019 | Aug 2, 2021 | SAP_001.pdf |
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| Plasma Total Radioactivity Whole Blood Total Radioactivity Pharmacokinetics: Time of Cmax (Tmax) | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
| Plasma Pamiparib Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2) | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
| Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2) | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
| Plasma Pamiparib Pharmacokinetics: Apparent Total Clearance (CL/F) | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
| Plasma Pamiparib Pharmacokinetics: Apparent Volume of Distribution (Vz/F) | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
| Plasma Pamiparib Pharmacokinetics: AUC0-∞ of Plasma Pamiparib Relative to AUC0-∞ of Plasma Total Radioactivity | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
| Plasma Pharmacokinetics: AUC0-∞ of Whole Blood Total Radioactivity to AUC0-∞ of Plasma Total Radioactivity | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
| Percentage of Total Radioactivity Excreted in Urine | 192 hours of [14C]-Pamiparib Administration |
| Cumulative Urinary Excretion of Pamiparib | 192 hours of [14C]-Pamiparib Administration |
| Renal Clearance of Pamiparib (CLR) | 192 hours of [14C]-Pamiparib Administration |
| Fecal Recovery of Total Radioactivity | 192 hours of [14C]-Pamiparib Administration |
| Cumulative Recovery of Total Radioactivity in Total Excreta | 192 hours of [14C]-Pamiparib Administration |
| Number of Participants With Clinically Significant Abnormalities in 12-lead ECG Parameters, Vital Signs Data, Physical Examinations and Weight Data |
| Up to 6 months |
| Pamiparib Metabolite Identified and Metabolic Profile Using Measured Mass (M3) | Human plasma, urine, and feces samples were analyzed by LC-MS. | 0.5, 1, 2, 6, 12, 24, 48, 72, 96, 120, and 144 hours post dose on Days 1 to 7 |
| Liverpool |
| United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Participants |
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|
| Primary | Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to Infinity (AUC0-∞) | The PK population included all participants who received at least on dose of [14C]-pamiparib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ngEq/g | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
|
|
|
| Primary | Plasma Pamiparib Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t) | The PK population included all participants who received at least on dose of [14C]-pamiparib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
|
|
|
| Primary | Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC-t) | The PK population included all participants who received at least on dose of [14C]-pamiparib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ngEq/g | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
|
|
|
| Primary | Plasma Pamiparib Pharmacokinetics: Maximum Observed Concentration (Cmax) of Pamiparib | The PK population included all participants who received at least on dose of [14C]-pamiparib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
|
|
|
| Primary | Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Maximum Observed Concentration (Cmax) | The PK population included all participants who received at least on dose of [14C]-pamiparib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ngEq/g | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
|
|
|
| Primary | Plasma Pamiparib Pharmacokinetics: Time of Cmax (Tmax) | The PK population included all participants who received at least on dose of [14C]-pamiparib and had evaluable PK data. | Posted | Median | Full Range | hours | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
|
|
|
| Primary | Plasma Total Radioactivity Whole Blood Total Radioactivity Pharmacokinetics: Time of Cmax (Tmax) | The PK population included all participants who received at least on dose of [14C]-pamiparib and had evaluable PK data. | Posted | Median | Full Range | hours | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
|
|
|
| Primary | Plasma Pamiparib Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2) | The PK population included all participants who received one dose of [14C]-pamiparib and had evaluable PK data. | Posted | Mean | Standard Deviation | hours | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
|
|
|
| Primary | Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2) | The PK population included all participants who received one dose of [14C]-pamiparib and had evaluable PK data. | Posted | Mean | Standard Deviation | hours | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
|
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| Primary | Plasma Pamiparib Pharmacokinetics: Apparent Total Clearance (CL/F) | The PK population included all participants who received one dose of [14C]-pamiparib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters/hour (L/h) | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
|
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| Primary | Plasma Pamiparib Pharmacokinetics: Apparent Volume of Distribution (Vz/F) | The PK population included all participants who received one dose of [14C]-pamiparib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
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| Primary | Plasma Pamiparib Pharmacokinetics: AUC0-∞ of Plasma Pamiparib Relative to AUC0-∞ of Plasma Total Radioactivity | The PK population included all participants who received at least on dose of [14C]-pamiparib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
|
|
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| Primary | Plasma Pharmacokinetics: AUC0-∞ of Whole Blood Total Radioactivity to AUC0-∞ of Plasma Total Radioactivity | The PK population included all participants who received one dose of [14C]-pamiparib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7 |
|
|
|
| Primary | Percentage of Total Radioactivity Excreted in Urine | The PK population included all participants who received one dose of [14C]-pamiparib and had evaluable PK data. | Posted | Mean | Standard Deviation | % Excreted | 192 hours of [14C]-Pamiparib Administration |
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|
| Primary | Cumulative Urinary Excretion of Pamiparib | The PK population included all participants who received one dose of [14C]-pamiparib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg | 192 hours of [14C]-Pamiparib Administration |
|
|
|
| Primary | Renal Clearance of Pamiparib (CLR) | The PK population included all participants who received one dose of [14C]-pamiparib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | CLR (L/h) | 192 hours of [14C]-Pamiparib Administration |
|
|
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| Primary | Fecal Recovery of Total Radioactivity | The PK population included all participants who received one dose of [14C]-pamiparib and had evaluable PK data. | Posted | Mean | Standard Deviation | % Excreted | 192 hours of [14C]-Pamiparib Administration |
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|
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| Primary | Cumulative Recovery of Total Radioactivity in Total Excreta | The PK population included all participants who received one dose of [14C]-pamiparib and had evaluable PK data. | Posted | Mean | Standard Deviation | % Excreted | 192 hours of [14C]-Pamiparib Administration |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events in Part1 and Part 2 | The safety population for Part 1 consisted of all participants who received 1 dose of study drug, 60 mg [14C]-pamiparib in Part 1 and the safety population for Part 2 consisted of all participants who participated in Part 1 and received at least 1 dose of 60 mg pamiparib in Part 2. | Posted | Number | number of participants | Up to 6 months |
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| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities | The safety population for Part 1 consisted of all participants who received 1 dose of study drug, 60 mg [14C]-pamiparib, in Part 1 and the safety population for Part 2 consisted of all participants who participated in Part 1 and received at least 1 dose of 60 mg pamiparib in Part 2. | Posted | Number | number of participants | Up to 6 months |
|
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| Secondary | Number of Participants With Clinically Significant Abnormalities in 12-lead ECG Parameters, Vital Signs Data, Physical Examinations and Weight Data | The safety population for Part 1 consisted of all participants who received at least 1 dose of study drug, 60 mg [14C]-pamiparib, in Part 1 and the safety population for Part 2 consisted of all participants who participated in Part 1 and received at least 1 dose of 60 mg pamiparib in Part 2. | Posted | Number | Number of participants | Up to 6 months |
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| Secondary | Pamiparib Metabolite Identified and Metabolic Profile Using Measured Mass (M3) | Human plasma, urine, and feces samples were analyzed by LC-MS. | The PK population included all participants who received one dose of [14C]-pamiparib and had evaluable PK data. | Posted | Number | Da | 0.5, 1, 2, 6, 12, 24, 48, 72, 96, 120, and 144 hours post dose on Days 1 to 7 |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| Abdominal distension | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Amylase increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Influenza like illness | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Radiculopathy | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
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BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.
| Title | Measurements |
|---|---|
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| Part 2: Participants with SAEs |
|