Trial Outcomes & Findings for Treatment of Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Deficiency (NCT NCT03712930)

Last Updated: 2021-11-17

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Up to 1 year and 6 months

Results posted on

2021-11-17

Participant Flow

Eighteen subjects were screened; 5 subjects failed screening and 13 subjects were dosed.

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.

Participant milestones

Participant milestones
Measure	Pamiparib Participants received 60 mg pamiparib orally twice daily
Overall Study STARTED	13
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Pamiparib Participants received 60 mg pamiparib orally twice daily
Overall Study Death	7
Overall Study Physician Decision	1
Overall Study Study Terminated by Sponsor	3
Overall Study Progressive Disease	2

Baseline Characteristics

Treatment of Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Deficiency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pamiparib n=13 Participants Participants received 60 mg pamiparib orally twice daily
Age, Continuous	69.3 years STANDARD_DEVIATION 9.49 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race/Ethnicity, Customized Race: American Indian or Alaska Native, White	1 Participants n=5 Participants
Race/Ethnicity, Customized Race: White	7 Participants n=5 Participants
Race/Ethnicity, Customized Race: Not Reported	1 Participants n=5 Participants
Race/Ethnicity, Customized Race: Unknown	3 Participants n=5 Participants
Race/Ethnicity, Customized Race: Other	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity: Not Hispanic or Latino	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported/Unknown	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year and 6 months

Population: 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.

Outcome measures

Outcome measures
Measure	Pamiparib n=12 Participants Participants received 60 mg pamiparib orally twice daily
Objective Response Rate (ORR) Determined by Independent Review Committee	0 Percentage of participants

PRIMARY outcome

Timeframe: Up to 1 year and 6 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pamiparib n=13 Participants Participants received 60 mg pamiparib orally twice daily
Prostate-Specific Antigen (PSA) Response Rate	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 1 year and 7 months

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.

Outcome measures

Outcome measures
Measure	Pamiparib n=12 Participants Participants received 60 mg pamiparib orally twice daily
Duration of Response (DOR) by IRC	NA Months No confirmed CR/PR. Duration of Response is not applicable.

SECONDARY outcome

Timeframe: Up to 1 year and 6 months

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.

Outcome measures

Outcome measures
Measure	Pamiparib n=12 Participants Participants received 60 mg pamiparib orally twice daily
Objective Response Rate by Investigator	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 1 year and 6 months

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.

Outcome measures

Outcome measures
Measure	Pamiparib n=12 Participants Participants received 60 mg pamiparib orally twice daily
Time to Objective Response by Investigator	NA Months No participants with confirmed CR/PR. Time to response is not applicable.

SECONDARY outcome

Timeframe: Up to 1 year and 6 months

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.

Outcome measures

Outcome measures
Measure	Pamiparib n=12 Participants Participants received 60 mg pamiparib orally twice daily
Clinical Benefit Rate By Investigator	25 Percentage of participants

SECONDARY outcome

Timeframe: Up to 1 year and 6 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pamiparib n=13 Participants Participants received 60 mg pamiparib orally twice daily
Time to PSA Response	NA Months Number of participants with PSA response is 0. Time to PSA response is not applicable.

SECONDARY outcome

Timeframe: Up to 1 year and 7 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pamiparib n=13 Participants Participants received 60 mg pamiparib orally twice daily
Duration of PSA Response	NA Months The number of participants with PSA Response is 0. Duration of PSA response is not applicable.

SECONDARY outcome

Timeframe: Up to 1 year and 7 months

Population: Safety Analysis Set : includes all participants enrolled into the study who received any dose of pamiparib.

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.

Outcome measures

Outcome measures
Measure	Pamiparib n=13 Participants Participants received 60 mg pamiparib orally twice daily
Time to PSA Progression	3.13 Months Standard Deviation 1.533

SECONDARY outcome

Timeframe: Up to 1 year and 7 months

Population: Safety Analysis Set: includes all participants enrolled in the study who received any dose of pamiparib

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.

Outcome measures

Outcome measures
Measure	Pamiparib n=13 Participants Participants received 60 mg pamiparib orally twice daily
Time to Symptomatic Skeletal Event	NA Months No participants had SSE

SECONDARY outcome

Timeframe: Up to 1 year and 7 months

Population: Safety Analysis Set : includes all participants enrolled in the study who received any dose of pamiparib

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.

Outcome measures

Outcome measures
Measure	Pamiparib n=13 Participants Participants received 60 mg pamiparib orally twice daily
Radiographic Progression-Free Survival by IRC	2.6 Months Interval 1.5 to 3.7

SECONDARY outcome

Timeframe: Up to 1 year and 7 months

Population: Safety Analysis Set: includes all participants enrolled in the study who received any dose of pamiparib

Overall survival is defined as the time from the date of the first dose of study drug to death due to any cause.

Outcome measures

Outcome measures
Measure	Pamiparib n=13 Participants Participants received 60 mg pamiparib orally twice daily
Overall Survival (OS)	5.8 Months Interval 1.6 to 5.9

SECONDARY outcome

Timeframe: 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)

Population: Safety Analysis Set: includes all participants enrolled in the study who received any dose of pamiparib

Outcome measures

Outcome measures
Measure	Pamiparib n=13 Participants Participants received 60 mg pamiparib orally twice daily
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 Serious	6 number of participants
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 Leading to Death	1 number of participants
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 Leading to Treatment Discontinuation	3 number of participants
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 Leading to Dose Modification	11 number of participants
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 Leading to Dose Interruption	9 number of participants
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 Leading to Dose Reduction	5 number of participants
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 Treatment Related TEAEs	11 number of participants
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 Treatment Related Grade 3 or Higher	7 number of participants
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 Treatment Related Serious	1 number of participants
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 Treatment Related Leading to Death	0 number of participants
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 Treatment Related Leading to Treatment Discontinuation	3 number of participants
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 Treatment Related Leading to Dose Modification	7 number of participants
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 Treatment Related Leading to Dose Interruption	6 number of participants
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 Treatment Related Leading to Dose Reduction	3 number of participants
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 Participants with at Least One TEAE	13 number of participants
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 Grade 3 or Higher	11 number of participants

Adverse Events

Pamiparib

Serious events: 6 serious events

Other events: 13 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Pamiparib n=13 participants at risk Participants received 60 mg pamiparib orally twice daily
General disorders Pyrexia	15.4% 2/13 • 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)
Blood and lymphatic system disorders Anemia	7.7% 1/13 • 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)
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • 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)
Metabolism and nutrition disorders Dehydration	7.7% 1/13 • 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)
Blood and lymphatic system disorders Febrile neutropenia	7.7% 1/13 • 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)
Nervous system disorders Hemiparesis	7.7% 1/13 • 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)
Renal and urinary disorders Hydronephrosis	7.7% 1/13 • 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)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	7.7% 1/13 • 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)
Blood and lymphatic system disorders Neutropenia	7.7% 1/13 • 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)
Infections and infestations Oesophageal candidiasis	7.7% 1/13 • 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)
Blood and lymphatic system disorders Pancytopenia	7.7% 1/13 • 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)
General disorders Peripheral swelling	7.7% 1/13 • 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)
Respiratory, thoracic and mediastinal disorders Respiratory failure	7.7% 1/13 • 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)
Renal and urinary disorders Ureteric obstruction	7.7% 1/13 • 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)

Other adverse events

Other adverse events
Measure	Pamiparib n=13 participants at risk Participants received 60 mg pamiparib orally twice daily
Blood and lymphatic system disorders Anaemia	53.8% 7/13 • 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)
Gastrointestinal disorders Nausea	53.8% 7/13 • 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)
Metabolism and nutrition disorders Decreased appetite	46.2% 6/13 • 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)
General disorders Fatigue	38.5% 5/13 • 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)
Gastrointestinal disorders Diarrhoea	30.8% 4/13 • 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)
Gastrointestinal disorders Vomiting	30.8% 4/13 • 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)
Investigations Weight decreased	23.1% 3/13 • 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)
Investigations Blood alkaline phosphatase increased	15.4% 2/13 • 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)
Investigations Blood creatinine increased	15.4% 2/13 • 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)
Blood and lymphatic system disorders Neutropenia	15.4% 2/13 • 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)
Musculoskeletal and connective tissue disorders Pain in extremity	15.4% 2/13 • 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)
Blood and lymphatic system disorders Thrombocytopenia	15.4% 2/13 • 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)
Infections and infestations Urinary tract infection	15.4% 2/13 • 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)
Gastrointestinal disorders Abdominal pain	7.7% 1/13 • 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)
Investigations Aspartate aminotransferase increased	7.7% 1/13 • 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)
General disorders Asthenia	7.7% 1/13 • 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)
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • 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)
Investigations Blood lactate dehydrogenase increased	7.7% 1/13 • 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)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	7.7% 1/13 • 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)
Gastrointestinal disorders Constipation	7.7% 1/13 • 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)
Skin and subcutaneous tissue disorders Decubitus ulcer	7.7% 1/13 • 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)
Metabolism and nutrition disorders Dehydration	7.7% 1/13 • 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)
Nervous system disorders Dizziness	7.7% 1/13 • 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)
Eye disorders Dry eye	7.7% 1/13 • 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)
Gastrointestinal disorders Dry mouth	7.7% 1/13 • 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)
Nervous system disorders Dysgeusia	7.7% 1/13 • 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)
Gastrointestinal disorders Dyspepsia	7.7% 1/13 • 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)
Musculoskeletal and connective tissue disorders Flank pain	7.7% 1/13 • 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)
Gastrointestinal disorders Gastrooesophageal reflux disease	7.7% 1/13 • 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)
Renal and urinary disorders Haematuria	7.7% 1/13 • 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)
Nervous system disorders Headache	7.7% 1/13 • 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)
Metabolism and nutrition disorders Hypocalcaemia	7.7% 1/13 • 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)
Metabolism and nutrition disorders Hypophosphataemia	7.7% 1/13 • 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)
Blood and lymphatic system disorders Leukopenia	7.7% 1/13 • 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)
Metabolism and nutrition disorders Malnutrition	7.7% 1/13 • 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)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	7.7% 1/13 • 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)
Musculoskeletal and connective tissue disorders Myalgia	7.7% 1/13 • 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)
Infections and infestations Oral candidiasis	7.7% 1/13 • 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)
Eye disorders Orbital oedema	7.7% 1/13 • 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)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.7% 1/13 • 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)
Reproductive system and breast disorders Pelvic pain	7.7% 1/13 • 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)
Investigations Platelet count decreased	7.7% 1/13 • 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)
Gastrointestinal disorders Rectal haemorrhage	7.7% 1/13 • 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)
Gastrointestinal disorders Rectal tenesmus	7.7% 1/13 • 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)
Nervous system disorders Taste disorder	7.7% 1/13 • 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)
Ear and labyrinth disorders Vertigo	7.7% 1/13 • 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)

Additional Information

Study Director

BeiGene

Phone: +1-877-828-5568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER