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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002587-28 | EudraCT Number |
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Sponsor's decision to revisit the development approach for prostate cancer.
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This study is designed to evaluate the efficacy of pamiparib in participants with metastatic castration-resistant prostate cancer (mCRPC) positive for circulating tumor cells (CTC) with homologous recombination deficiency (CTC-HRD). All participants will receive pamiparib. The purpose of this study is to demonstrate that pamiparib will improve Objective Response Rate (ORR) and Prostate-Specific Antigen (PSA) response rate
This is a global, Phase 2, open-label study of pamiparib in approximately 100 participants with metastatic castration-resistant prostate cancer (mCRPC) positive for circulating tumor cells (CTC) with homologous recombination deficiency (CTC-HRD). Participants in Cohort 1 will include 50 mCRPC participants with CTC-HRD-positive, measurable metastatic disease (soft tissue with/without bone lesions), and positive BRCA1/2 mutation or negative/unknown BRCA1/2 mutation. Cohort 2 will include 30 mCRPC CTC-HRD positive participants with bone metastasis only and positive or negative/unknown BRCA1/2. Cohort 3 and 4 will include 20 mCRPC CTC-HRD negative/unknown participants with BRCA1/2 positive mutations, metastatic disease (measurable soft tissue with/without bone), and bone only. Participants will undergo PSA level assessments approximately every 4 weeks as well as tumor assessments every 8 weeks for 24 weeks and the every 12 weeks, or as clinically indicated. Administration of pamiparib will continue until disease progression, unacceptable toxicity, death or another discontinuation criterion is met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pamiparib | Experimental | Participants will receive pamiparib for a period up to 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pamiparib | Drug | 60 mg orally twice daily (BID) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Determined by Independent Review Committee | ORR is the percentage of participants with a best objective response of complete response (CR) or partial response (PR) confirmed at a subsequent timepoint ≥ 4 weeks later by an Independent Review Committee (IRC). | Up to 1 year and 6 months |
| Prostate-Specific Antigen (PSA) Response Rate | PSA response rate is defined as the percentage of participants with PSA decline ≥ 50% from baseline [confirmed by a second PSA value ≥ 3 weeks later] for CTC-HRD-positive participants with or without measurable disease. | Up to 1 year and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) by IRC | DOR is defined as the time from the date of the earliest documented CR or PR (that is subsequently confirmed) to radiographic disease progression or death due to any cause, whichever occurs first. | Up to 1 year and 7 months |
| Objective Response Rate by Investigator |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Prior treatment for prostate cancer with any of the following:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Cancer and Blood Center | Athens | Georgia | 30607 | United States | ||
| Montefiore Einstein Cancer Center |
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All subjects enrolled had unknown BRCA1/2 status at study entry and were assigned to cohorts 1B or 2B; there were no subjects known to be BRCA1/2 positive at enrollment.
Eighteen subjects were screened; 5 subjects failed screening and 13 subjects were dosed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pamiparib | Participants received 60 mg pamiparib orally twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Oct 16, 2018 | Aug 2, 2021 |
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ORR is the percentage of participants with a best objective response of complete response (CR) or partial response (PR) confirmed at a subsequent timepoint ≥ 4 weeks later by the investigator. |
| Up to 1 year and 6 months |
| Time to Objective Response by Investigator | Time to objective response is defined as the time from the date of the first dose of study drug to the first documented confirmed response of CR or PR assessed by the investigator and summarized for participants who have achieved a confirmed objective response. | Up to 1 year and 6 months |
| Clinical Benefit Rate By Investigator | Clinical Benefit Rate is the percentage of participants who achieved confirmed CR, PR, or SD or NON-CR/NON-PD. The minimum interval for confirmed CR and PR is 4 weeks and the measurement of SD or NON-CR/NON-PD is 7 weeks after first dose date. | Up to 1 year and 6 months |
| Time to PSA Response | Time to PSA response is defined as the time from the date of the first dose of study drug to the first PSA decline ≥ 50% that is subsequently confirmed. Assessments are summarized for participants who have achieved a confirmed PSA response. | Up to 1 year and 6 months |
| Duration of PSA Response | Duration of PSA response is defined as the time from the date of the earliest documented PSA response (that is subsequently confirmed) to PSA progression or death due to any cause, whichever occurs first. PSA progression is defined as a ≥ 25% increase in PSA with an absolute increase of ≥ 2 μg/L above the nadir (or above the baseline for participants with no PSA decline) after12 weeks, confirmed by a second value ≥ 3 weeks later. The nadir is defined as the lowest value at or after baseline. | Up to 1 year and 7 months |
| Time to PSA Progression | Time to PSA progression is defined as the time from the date of the first dose of study drug to a ≥ 25% increase in PSA with an absolute increase of ≥ 2 ng/mL above the nadir (or above the baseline for participants with no PSA decline) after 12 weeks, confirmed by a second value ≥ 3 weeks later. Death for the participants with no PSA progression is also considered as an event. | Up to 1 year and 7 months |
| Time to Symptomatic Skeletal Event | Time to symptomatic skeletal event (SSE) is defined as time from the date of the first dose of study drug to the first symptomatic fracture, radiation or surgery to bone, or spinal cord compression. | Up to 1 year and 7 months |
| Radiographic Progression-Free Survival by IRC | Radiographic progression-free survival is defined as the time from the date of the first dose of study drug to radiographic disease progression by IRC or death due to any cause, whichever occurs first. | Up to 1 year and 7 months |
| Overall Survival (OS) | Overall survival is defined as the time from the date of the first dose of study drug to death due to any cause. | Up to 1 year and 7 months |
| Number of Participants With Treatment-Emergent Adverse Events Graded According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | From the date of first Pamiparib dose until 30 days after the last dose or initiation of new anti-cancer therapy, whichever occurs first. (Up to 1 year and 7 months) |
| The Bronx |
| New York |
| 10461 |
| United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Gosford Hospital | Gosford | New South Wales | 2250 | Australia |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| Calvary Mater Newcastle | Waratah | New South Wales | 2298 | Australia |
| Icon Cancer Care Foundation | South Brisbane | Queensland | 044101 | Australia |
| Pan American Oncology Trials, LLC | Rio Piedras | 935 | Puerto Rico |
| L Hospitalet de Llobregat | Barcelona | 8035 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pamiparib | Participants received 60 mg pamiparib orally twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Objective Response Rate (ORR) Determined by Independent Review Committee | ORR is the percentage of participants with a best objective response of complete response (CR) or partial response (PR) confirmed at a subsequent timepoint ≥ 4 weeks later by an Independent Review Committee (IRC). | Efficacy-Evaluable Analysis Set: includes all participants in the Safety Analysis Set who had measurable disease at baseline and at least 1 post-baseline tumor assessment, unless they permanently discontinue pamiparib or the study early due to clinical progression or death before tumor assessment. Participants with available data were included in the analysis. | Posted | Number | Percentage of participants | Up to 1 year and 6 months |
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| ||||||||||||||||||||||||||
| Primary | Prostate-Specific Antigen (PSA) Response Rate | PSA response rate is defined as the percentage of participants with PSA decline ≥ 50% from baseline [confirmed by a second PSA value ≥ 3 weeks later] for CTC-HRD-positive participants with or without measurable disease. | PSA-Evaluable Analysis Set: includes all participants in the Safety Analysis Set with ≥3 rising PSA levels with ≥ 1 week between determinations and screening PSA ≥ 2 μg/L) and who had at least 1 post-baseline PSA measurement unless they permanently discontinue pamiparib or the study early due to clinical progression or death before completed PSA assessment. | Posted | Number | Percentage of participants | Up to 1 year and 6 months |
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| |||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) by IRC | DOR is defined as the time from the date of the earliest documented CR or PR (that is subsequently confirmed) to radiographic disease progression or death due to any cause, whichever occurs first. | Efficacy-Evaluable Analysis Set: includes all participants in the Safety Analysis Set who had measurable disease at baseline and at least 1 post-baseline tumor assessment, unless they permanently discontinue pamiparib or the study early due to clinical progression or death before tumor assessment. Participants with available data were included in the analysis. | Posted | Number | Months | Up to 1 year and 7 months |
|
| |||||||||||||||||||||||||||
| Secondary | Objective Response Rate by Investigator | ORR is the percentage of participants with a best objective response of complete response (CR) or partial response (PR) confirmed at a subsequent timepoint ≥ 4 weeks later by the investigator. | Efficacy-Evaluable Analysis Set: includes all participants in the Safety Analysis Set who had measurable disease at baseline and at least 1 post-baseline tumor assessment, unless they permanently discontinue pamiparib or the study early due to clinical progression or death before tumor assessment. Participants with available data were included in the analysis. | Posted | Number | Percentage of participants | Up to 1 year and 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Objective Response by Investigator | Time to objective response is defined as the time from the date of the first dose of study drug to the first documented confirmed response of CR or PR assessed by the investigator and summarized for participants who have achieved a confirmed objective response. | Efficacy-Evaluable Analysis Set: includes all participants in the Safety Analysis Set who had measurable disease at baseline and at least 1 post-baseline tumor assessment, unless they permanently discontinue pamiparib or the study early due to clinical progression or death before tumor assessment. Participants with available data were included in the analysis. | Posted | Number | Months | Up to 1 year and 6 months |
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| |||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate By Investigator | Clinical Benefit Rate is the percentage of participants who achieved confirmed CR, PR, or SD or NON-CR/NON-PD. The minimum interval for confirmed CR and PR is 4 weeks and the measurement of SD or NON-CR/NON-PD is 7 weeks after first dose date. | Efficacy-Evaluable Analysis Set: includes all participants in the Safety Analysis Set who had measurable disease at baseline and at least 1 post-baseline tumor assessment, unless they permanently discontinue pamiparib or the study early due to clinical progression or death before tumor assessment. Participants with available data were included in the analysis. | Posted | Number | Percentage of participants | Up to 1 year and 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Time to PSA Response | Time to PSA response is defined as the time from the date of the first dose of study drug to the first PSA decline ≥ 50% that is subsequently confirmed. Assessments are summarized for participants who have achieved a confirmed PSA response. | PSA-Evaluable Analysis Set: includes all participants in the Safety Analysis Set with ≥3 rising PSA levels with ≥ 1 week between determinations and screening PSA ≥ 2 μg/L and who had at least 1 post-baseline PSA measurement, unless they permanently discontinue pamiparib or the study early due to clinical progression or death before completed PSA assessment. | Posted | Number | Months | Up to 1 year and 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Duration of PSA Response | Duration of PSA response is defined as the time from the date of the earliest documented PSA response (that is subsequently confirmed) to PSA progression or death due to any cause, whichever occurs first. PSA progression is defined as a ≥ 25% increase in PSA with an absolute increase of ≥ 2 μg/L above the nadir (or above the baseline for participants with no PSA decline) after12 weeks, confirmed by a second value ≥ 3 weeks later. The nadir is defined as the lowest value at or after baseline. | PSA-Evaluable Analysis Set: includes all participants in the Safety Analysis Set with ≥3 rising PSA levels with ≥ 1 week between determinations and screening PSA ≥ 2 μg/L) and who had at least 1 post-baseline PSA measurement, unless they permanently discontinue pamiparib or the study early due to clinical progression or death before completed PSA assessment. | Posted | Number | Months | Up to 1 year and 7 months |
|
| |||||||||||||||||||||||||||
| Secondary | Time to PSA Progression | Time to PSA progression is defined as the time from the date of the first dose of study drug to a ≥ 25% increase in PSA with an absolute increase of ≥ 2 ng/mL above the nadir (or above the baseline for participants with no PSA decline) after 12 weeks, confirmed by a second value ≥ 3 weeks later. Death for the participants with no PSA progression is also considered as an event. | Safety Analysis Set : includes all participants enrolled into the study who received any dose of pamiparib. | Posted | Mean | Standard Deviation | Months | Up to 1 year and 7 months |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Symptomatic Skeletal Event | Time to symptomatic skeletal event (SSE) is defined as time from the date of the first dose of study drug to the first symptomatic fracture, radiation or surgery to bone, or spinal cord compression. | Safety Analysis Set: includes all participants enrolled in the study who received any dose of pamiparib | Posted | Number | Months | Up to 1 year and 7 months |
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| Secondary | Radiographic Progression-Free Survival by IRC | Radiographic progression-free survival is defined as the time from the date of the first dose of study drug to radiographic disease progression by IRC or death due to any cause, whichever occurs first. | Safety Analysis Set : includes all participants enrolled in the study who received any dose of pamiparib | Posted | Median | 95% Confidence Interval | Months | Up to 1 year and 7 months |
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| Secondary | Overall Survival (OS) | Overall survival is defined as the time from the date of the first dose of study drug to death due to any cause. | Safety Analysis Set: includes all participants enrolled in the study who received any dose of pamiparib | Posted | Median | 95% Confidence Interval | Months | Up to 1 year and 7 months |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events Graded According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | Safety Analysis Set: includes all participants enrolled in the study who received any dose of pamiparib | Posted | Number | number of participants | From the date of first Pamiparib dose until 30 days after the last dose or initiation of new anti-cancer therapy, whichever occurs first. (Up to 1 year and 7 months) |
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From the date of first dose of Pamiparib until 30 days after the last dose or initiation of new anti-cancer therapy, whichever occurs first (up to approximately 1 year and 7 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 | Participants received 60 mg pamiparib orally twice daily | 9 | 13 | 6 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Hemiparesis | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Oesophageal candidiasis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Weight decreased | Investigations | 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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| Blood creatinine increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Dry eye | Eye 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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| Dysgeusia | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Malnutrition | Metabolism and nutrition 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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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Orbital oedema | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Rectal tenesmus | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | 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 | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | +1-877-828-5568 | clinicaltrials@beigene.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 2, 2020 | Aug 2, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000707927 | pamiparib |
Not provided
Not provided
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| Race: Not Reported |
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| Race: Unknown |
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| Race: Other |
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| Ethnicity: Not Hispanic or Latino |
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| Hispanic or Latino |
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| Not Reported/Unknown |
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