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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000112-28 | EudraCT Number |
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The study was an open-label, parallel-group, fixed-sequence study in male and female cancer patients. The study consists of 2 phases: the Core Phase, which is divided into Part A and Part B, and the Extension Phase. Part A investigated the effect of CYP3A induction by rifampin on the single dose pharmacokinetics (PK) of pamiparib, and Part B investigated the effect of CYP3A inhibition by itraconazole on the single dose PK of pamiparib. Participants were offered participation in the Extension Phase, in which they received pamiparib until progression of disease, unacceptable toxicity, withdrawal of consent, or any other reason for discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A (core phase) | Experimental | 60 mg pamiparib administered orally on Days 1 and 10 fasting 8 hours pre-dose 600 mg rifampin once a day from days 3 to 11 in the fasted state (at least 2 hours predose) |
|
| Part B (core phase) | Experimental | Single dose of 20 mg pamiparib orally in the fasted state (at least 8 hours predose) on days 1 and 7 200 mg itraconazole once a day approximately 30 minutes after completing a meal Day 3 to day 8 |
|
| Extension phase | Experimental | 60 mg pamiparib orally twice a day in 28-day cycles until progression of disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pamiparib 60 mg | Drug | Single dose of 60 mg pamiparib orally on Days 1 and 10 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Pamiparib in Plasma for Part A | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose | |
| Maximum Observed Concentration (Cmax) of Pamiparib in Plasma for Part B | Part B: from Day -1 (admission) to Day 9 (discharge; ) 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose | |
| AUC From Time Zero to Time of Last Quantifiable Concentration Post-dose (AUC0-tlast) in Plasma for Part A | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose | |
| AUC From Time Zero to Time of Last Quantifiable Concentration Post-dose (AUC0-tlast) in Plasma for Part B | Part B: from Day -1 (admission) to Day 9 (discharge) 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose | |
| AUC From Zero to Infinity (AUC0-inf) of Pamiparib in Plasma for Part A | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose | |
| AUC From Zero to Infinity (AUC0-inf) of Pamiparib in Plasma for Part B | Part B: from Day -1 (admission) to Day 9 (discharge) 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose | |
| AUC From Zero to 12 Hours (AUC0-12) of Pamiparib in Plasma for Part A | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, and 12 hours post-dose | |
| AUC From Zero to 12 Hours (AUC0-12) of Pamiparib in Plasma for Part B |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAE is defined as any AE with an onset date on or after the date of first dose of study medication until the date of last study medication dose plus 30 days. Seriousness of the AE is determined by the investigator based on seriousness criteria. | From the date informed consent has been signed until last study medication dose plus 30 days (up to approximately 26 months) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
History of hypersensitivity to rifampin, any rifamycin or any of the components of the rifampin capsule (Part A).
History of hypersensitivity to itraconazole or any of the components of the itraconazole capsule (Part B).
Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor at therapeutic doses is allowed, provided that such treatment was not the most recent therapy (PARP inhibitor must have been discontinued ≥ 3 months prior to the first dose of pamiparib):
- Participants who experienced prior severe toxicity to PARP inhibitors that in the opinion of the investigator precludes further treatment with PARP inhibitors should be excluded
Diagnosis of Myelodysplastic syndrome (MDS)
Active infection requiring systemic treatment
Any of the following cardiovascular criteria:
Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before Day 1 of pamiparib administration
Symptomatic pulmonary embolism ≤ 28 days before Day 1 of pamiparib administration
Any history of acute myocardial infarction ≤ 6 months before Day 1 of pamiparib administration
Any history of heart failure meeting New York Heart Association Classification III or IV ≤ 6 months before Day 1 of pamiparib
- Participants with congestive heart failure or history of heart failure should be excluded from Part B (itraconazole)
Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before Day 1 of pamiparib administration
Any history of cerebral vascular accident ≤ 6 months before Day 1 of pamiparib administration
Previous complete gastric resection or lap-band surgery, chronic diarrhea, active inflammatory gastrointestinal disease, known diverticular disease or any other disease-causing malabsorption syndrome
- Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed
Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis, or melena ≤ 6 months before Day 1 of pamiparib administration
Use or anticipated need for food or drugs known to be strong or moderate CYP3A inhibitors or strong CYP3A inducers ≤ 14 days (or ≤ 5 half-lives if half-life is known) prior to Day 1 of pamiparib administration
Known history of intolerance to the excipients of the pamiparib capsule
Have known hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arensia Exploratory Medicine Llc | Tbilisi | 0112 | Georgia | |||
| Republican Clinical Hospital, Oncology Department |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33772633 | Result | Mu S, Lin C, Skrzypczyk-Ostaszewicz A, Bulat I, Maglakelidze M, Skarbova V, Andreu-Vieyra C, Sahasranaman S. The pharmacokinetics of pamiparib in the presence of a strong CYP3A inhibitor (itraconazole) and strong CYP3A inducer (rifampin) in patients with solid tumors: an open-label, parallel-group phase 1 study. Cancer Chemother Pharmacol. 2021 Jul;88(1):81-88. doi: 10.1007/s00280-021-04253-x. Epub 2021 Mar 27. |
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The screening period consisted of Days -28 to -1.
This study consisted of a core phase and an extension phase. A total of 25 participants were enrolled in Poland, Moldova, Slovakia, and Georgia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Core Phase: Arm A: Pamiparib + Rifampin | Participants received 60 milligrams (mg) pamiparib orally on Days 1 and 10 fasting 8 hours pre-dose + 600 mg rifampin orally from Day 3 to Day 11 fasting at least 2 hours pre-dose |
| FG001 | Core Phase: Arm B: Pamiparib + Itraconazole | Participants received 20 mg pamiparib orally on Days 1 and 7 fasting at least 8 hours pre-dose + 200 mg itraconazole orally 30 minutes after meal Day 3 to Day 8 |
| FG002 | Extension Phase | Participants received 60 mg pamiparib orally twice a day in 28-day cycles until progression of disease, unacceptable toxicity, withdrawal of consent, or any other reason for discontinuation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Core Phase |
|
| ||||||||||||||||||
| Extension Phase |
|
The safety population included all participants who received at least 1 dose of pamiparib
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| ID | Title | Description |
|---|---|---|
| BG000 | Core Phase: Arm A: Pamiparib + Rifampin | Participants received 60 mg pamiparib orally on Days 1 and 10 fasting 8 hours pre-dose + 600 mg rifampin orally from Day 3 to Day 11 fasting at least 2 hours pre-dose |
| BG001 | Core Phase: Arm B: Pamiparib + Itraconazole |
| 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 | Maximum Observed Concentration (Cmax) of Pamiparib in Plasma for Part A | The pharmacokinetic (PK) population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an adverse event (AE) of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | ng/mL | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose |
|
From the date informed consent has been signed until last study medication dose plus 30 days (up to approximately 26 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 | Core Phase: Arm A: Pamiparib + Rifampin | Participants received 60 milligrams (mg) pamiparib orally on Days 1 and 10 fasting 8 hours pre-dose + 600 mg rifampin orally from Day 3 to Day 11 fasting at least 2 hours pre-dose |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | meddra 24.0 | 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 | Jun 14, 2019 | Jul 7, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 19, 2019 | Jul 7, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000707927 | pamiparib |
| D017964 | Itraconazole |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| pamiparib 20 mg |
| Drug |
Single dose of 20 mg pamiparib orally on days 1 and 7 |
|
| itraconazole | Drug | 200 mg itraconazole once a day al Day 3 to day 8 |
|
| rifampin | Drug | 600 mg rifampin once a day from days 3 to 11 |
|
| pamiparib | Drug | 60 mg pamiparib orally twice a day in 28-day cycles |
|
| Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, and 12 hours post-dose |
| AUC From Zero to 9 Hours (AUC0-9) of Pamiparib in Plasma for Part A | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, and 9 hours post-dose |
| AUC From Zero to 9 Hours (AUC0-9) of Pamiparib in Plasma for Part B | Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, and 9 hours post-dose |
| Time of the Maximum Observed Concentration (Tmax) of Pamiparib for Part A | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose |
| Time of the Maximum Observed Concentration (Tmax) of Pamiparib for Part B | Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose |
| Apparent Terminal Elimination Half-life (t1/2) of Pamiparib in Plasma for Part A | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose |
| Apparent Terminal Elimination Half-life (t1/2) of Pamiparib in Plasma for Part B | Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose |
| Apparent Oral Clearance (CL/F) of Pamiparib in Plasma for Part A | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose |
| Apparent Oral Clearance (CL/F) of Pamiparib in Plasma for Part B | Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose |
| Apparent Volume of Distribution (Vz/F) of Pamiparib in Plasma for Part A | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose |
| Apparent Volume of Distribution (Vz/F) of Pamiparib in Plasma for Part B | Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Assessments, Vital Signs, ECG Parameters and Physical Examinations | Up to approximately 26 months |
| Chiinu |
| 2025 |
| Moldova |
| Szpital Luxmed | Warsaw | 02-801 | Poland |
| Summit Clinical Research, Sro | Bratislava | 83101 | Slovakia |
| NOT COMPLETED |
|
|
Participants received 20 mg pamiparib orally on Days 1 and 7 fasting at least 8 hours pre-dose + 200 mg itraconazole orally 30 minutes after meal Day 3 to Day 8 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received 60 mg pamiparib Days 1 and 10 + 600 mg rifampin orally from Day 3 to Day 11 fasting at least 2 hours pre-dose
|
|
|
| Primary | Maximum Observed Concentration (Cmax) of Pamiparib in Plasma for Part B | The pharmacokinetic (PK) population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an adverse event (AE) of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | ng/mL | Part B: from Day -1 (admission) to Day 9 (discharge; ) 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose |
|
|
|
|
| Primary | AUC From Time Zero to Time of Last Quantifiable Concentration Post-dose (AUC0-tlast) in Plasma for Part A | The PK population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | hours*nanograms/milliLiter (h*ng/mL) | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose |
|
|
|
|
| Primary | AUC From Time Zero to Time of Last Quantifiable Concentration Post-dose (AUC0-tlast) in Plasma for Part B | The PK population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | hours*nanograms/milliLiter (h*ng/mL) | Part B: from Day -1 (admission) to Day 9 (discharge) 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose |
|
|
|
|
| Primary | AUC From Zero to Infinity (AUC0-inf) of Pamiparib in Plasma for Part A | The PK population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | hr*ng/mL | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose |
|
|
|
|
| Primary | AUC From Zero to Infinity (AUC0-inf) of Pamiparib in Plasma for Part B | The PK population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | hr*ng/mL | Part B: from Day -1 (admission) to Day 9 (discharge) 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose |
|
|
|
|
| Primary | AUC From Zero to 12 Hours (AUC0-12) of Pamiparib in Plasma for Part A | The PK population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | hr*ng/mL | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, and 12 hours post-dose |
|
|
|
| Primary | AUC From Zero to 12 Hours (AUC0-12) of Pamiparib in Plasma for Part B | The PK population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | hr*ng/mL | Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, and 12 hours post-dose |
|
|
|
| Primary | AUC From Zero to 9 Hours (AUC0-9) of Pamiparib in Plasma for Part A | The PK population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | hr*ng/mL | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, and 9 hours post-dose |
|
|
|
| Primary | AUC From Zero to 9 Hours (AUC0-9) of Pamiparib in Plasma for Part B | The PK population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | hr*ng/mL | Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, and 9 hours post-dose |
|
|
|
| Primary | Time of the Maximum Observed Concentration (Tmax) of Pamiparib for Part A | The PK population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | hours | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose |
|
|
|
| Primary | Time of the Maximum Observed Concentration (Tmax) of Pamiparib for Part B | The PK population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | hours | Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose |
|
|
|
| Primary | Apparent Terminal Elimination Half-life (t1/2) of Pamiparib in Plasma for Part A | The PK population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | hours | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose |
|
|
|
| Primary | Apparent Terminal Elimination Half-life (t1/2) of Pamiparib in Plasma for Part B | The PK population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | hours | Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose |
|
|
|
| Primary | Apparent Oral Clearance (CL/F) of Pamiparib in Plasma for Part A | The PK population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | Liters/hour (L/h) | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose |
|
|
|
| Primary | Apparent Oral Clearance (CL/F) of Pamiparib in Plasma for Part B | The PK population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | Liters/hour (L/h) | Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose |
|
|
|
| Primary | Apparent Volume of Distribution (Vz/F) of Pamiparib in Plasma for Part A | The PK population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | Liters | Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose |
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAE is defined as any AE with an onset date on or after the date of first dose of study medication until the date of last study medication dose plus 30 days. Seriousness of the AE is determined by the investigator based on seriousness criteria. | Safety Analysis Set includes all participants who received at least 1 dose of pamiparib | Posted | Number | Number of participants | From the date informed consent has been signed until last study medication dose plus 30 days (up to approximately 26 months) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Abnormalities in Laboratory Assessments, Vital Signs, ECG Parameters and Physical Examinations | Safety Population | Posted | Number | Number of participants | Up to approximately 26 months |
|
|
|
| Primary | Apparent Volume of Distribution (Vz/F) of Pamiparib in Plasma for Part B | The PK population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 x median tmax. | Posted | Median | Full Range | Liters | Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | Core Phase: Arm B: Pamiparib + Itraconazole | Participants received 20 mg pamiparib orally from Days 1 and 7 fasting at least 8 hours pre-dose + 200 mg itraconazole orally 30 minutes after meal Day 3 to Day 8 | 0 | 13 | 1 | 13 | 6 | 13 |
| EG002 | Extension Phase | Participants received 60 mg pamiparib orally twice a day in 28-day cycles until progression of disease, unacceptable toxicity, withdrawal of consent, or any other reason for discontinuation | 0 | 24 | 2 | 24 | 18 | 24 |
| Intestinal obstruction | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
|
| Macrocytosis | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | meddra 24.0 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | meddra 24.0 | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | meddra 24.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
|
| Duodenogastric reflux | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
|
| Catheter site inflammation | General disorders | meddra 24.0 | Systematic Assessment |
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| Fatigue | General disorders | meddra 24.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | meddra 24.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | meddra 24.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | meddra 24.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | meddra 24.0 | Systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | meddra 24.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | meddra 24.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | meddra 24.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | meddra 24.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | meddra 24.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | meddra 24.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | meddra 24.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | meddra 24.0 | Systematic Assessment |
|
| Weight decreased | Investigations | meddra 24.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | meddra 24.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
|
| Folate deficiency | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | meddra 24.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | meddra 24.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | meddra 24.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | meddra 24.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | meddra 24.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | meddra 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
|
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
|
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.
| D010879 |
| Piperazines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Physical Examinations |
|
| ECG Parameters |
|