CompletedNCT03333915Updated Feb 4, 2025Results posted

Study of the Efficacy, Safety and Pharmacokinetics of Pamiparib (BGB-290) in Participants With Advanced Solid Tumors

A Phase 1/2 interventional study of Pamiparib in Advanced High-grade Ovarian Cancer and Triple Negative Breast Cancer, sponsored by BeiGene. Completed at 6 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.

Sponsored by BeiGene · Phase 1/2, Interventional, and Treatment

From the registry’s dates

Registered 10 months after the study started (first participant enrolled Dec 2016, registered Nov 2017).

Phase: Phase 1/2
Study type: Interventional
Enrollment: 128
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

This study is designed to evaluate the safety, tolerability, PKharmacokinetic profile and treatment effect of pamiparib in Chinese participants with advanced high-grade ovarian cancer (including fallopian cancer or primary peritoneal cancer) and triple negative breast cancer in phase I, and to evaluate the efficacy and safety of pamiparib in Chinese participants with recurrent epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline breast cancer susceptibility gene 1/gene 2 (BRCA1/2) mutation in phase II.

Conditions studied

Advanced High-grade Ovarian Cancer
Triple Negative Breast Cancer

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Triple Negative Breast Neoplasms 1,163

In context

Triple Negative Breast Neoplasms

1,163 studies on the registry are indexed under Triple Negative Breast Neoplasms; 447 are open to participants now.

This study's enrollment of 128 is above the median of 61 across 1,001 interventional studies indexed under Triple Negative Breast Neoplasms.

Browse Triple Negative Breast Neoplasms studies →

Lead sponsor

BeiGene is the lead sponsor of 125 studies on the registry; 2 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 32 (59%) have results posted.

Browse BeOne Medicines studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

Participants have voluntarily agreed to participate by giving written informed consent.
Age 18 years (including 18 years) on the day of signing informed consent.
Participants meet the following eligibility criteria for the corresponding part of the study: 1) In Phase 1 portion: The participants must have a histologically or cytologically confirmed locally advanced or metastatic cancer, either triple-negative breast cancer or epithelial, non-mucinous, high-grade ovarian cancer (including fallopian cancer, or primary peritoneal cancer), for which no effective standard therapy is available.

2) In Phase 2 portion: Participants who have histologically or cytologically confirmed high-grade epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline BRCA1/2 mutation 4. Participants must have measurable disease as defined per the RECIST, version 1.1.

5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

Key Exclusion Criteria:

Participants who have been treated with chemotherapy, biologic therapy, immunotherapy, investigational agent, anti-cancer Chinese medicine, or anticancer herbal remedies ≤ 14 days (or ≤5 half-lives, whichever is shorter) prior to starting study drug, or who have not adequately recovered from the side effects of such therapy.
Participants who have undergone major surgery for any cause ≤ 4 weeks prior to starting study drug. Participants must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study.
Participants who have undergone radiotherapy for any cause ≤ 14 days prior to starting study drug. Participants must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study.
Untreated and/or active brain metastases.
Prior therapies targeting poly (ADP-ribose) polymerase (PARP).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 128 participants (actual)

Study arms

Experimental
Phase 1: 20 milligram (mg) pamiparib
20 mg pamiparib twice a day for 21 days
Drug: Pamiparib
Experimental
Phase 1 : 40 mg pamiparib
40 mg pamiparib twice a day for 21 days
Drug: Pamiparib
Experimental
60 mg pamiparib
60 mg pamiparib twice a day for 21 days
Drug: Pamiparib
Experimental
60 mg pamiparib in platinum-sensitive ovarian cancer (PSOC)
60 mg pamiparib twice a day until occurrence of unacceptable toxicities, disease progression, withdrawal of consent or investigator discretion
Drug: Pamiparib
Experimental
60 mg pamiparib in platinum resistant ovarian cancer (PROC)
60 mg pamiparib twice a day until occurrence of unacceptable toxicities, disease progression, withdrawal of consent or investigator discretion
Drug: Pamiparib

Interventions

DrugPamiparib
Pamiparib is provided as oral capsules
Also known as: BGB-290

What researchers measure

Primary outcomes

Phase 1: Number of Participants With Treatment- Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
A TEAE is defined as an adverse event (AE) that had an onset date on or after the first dose of study drug up to 30 days following study drug discontinuation or was worsening in severity from baseline (pretreatment).
Time frame: From first dose to within 30 days of last dose of pamiparib (approximately 36 months)
Phase 1: Number of Participants With Clinically Significant Abnormalities in Physical Examinations and Electrocardiograms (ECGs)
Time frame: From first dose to within 30 days of last dose of pamiparib (approximately 36 months)
Phase 2: Objective Response Rate (ORR) in High Grade Ovarian Cancer (HGOC) Both PSOC and PROC as Assessed by Independent Radiology Review Committee (IRC)
ORR is defined as the percentage of participants with confirmed Complete Response or Partial Response
Time frame: Up to approximately 2 years and 8 months

Secondary outcomes

Phase I: Maximum Observed Plasma Concentration (Cmax)
Time frame: Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase I: Time to Reach Cmax (Tmax)
Time frame: Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase I: Terminal Elimination Half-life (t1/2)
Time frame: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase I: Apparent Clearance (CL/F)
Time frame: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf)
Time frame: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase I: Apparent Volume of Distribution During Terminal Phase (Vz/F)
Time frame: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase I: Confirmed Objective Response Rate (ORR) as Assessed by the Investigator Per RECIST v1.1
ORR is defined as the percentage of participants with confirmed Complete Response (CR) or Partial Response (PR)
Time frame: Up to approximately 36 months
Phase 1: Disease Control Rate (DCR) Assessed by the Investigator Per RECIST v1.1
DCR is defined as the percentage of participants with best overall response (BOR) of CR, PR and stable disease (SD)
Time frame: Up to approximately 36 months
Phase I: Clinical Benefit Rate (CBR) Assessed by the Investigator Per RECIST v1.1
CBR is defined as percentage of participants with best overall response of CR, PR and stable disease (SD)≥24 weeks
Time frame: Up to approximately 36 months
Phase 1: Duration of Response (DOR) as Assessed by Investigator Per RECIST v1.1
DOR is defined as the time from the first determination of a confirmed overall response until the first documentation of progression or death, whichever comes first
Time frame: Up to approximately 36 months
Phase I : Progression Free Survival (PFS)
PFS is defined as the time from first dose of study medication to the first documented disease progression or death due to any cause, whichever occurs first
Time frame: Up to approximately 36 months
Phase 2: Objective Response Rate (ORR) by Investigator Per RECIST v1.1
ORR is defined as the percentage of participants with confirmed Complete Response or Partial Response
Time frame: Up to approximately 3 years and 8 months
Phase 2: Disease Control Rate by Investigator Per RECIST v1.1
DCR is defined as the percentage of participants with best overall response (BOR) of CR, PR and stable disease (SD)
Time frame: Up to approximately 3 years and 8 months
Phase 2: Clinical Benefit Rate by Investigator Per RECIST v1.1
CBR is defined as percentage of participants with best overall response of CR, PR and stable disease (SD)≥24 weeks
Time frame: Up to approximately 3 years and 8 months
Phase 2: Carcinoma Antigen-125 (C(A-125) Response Rate by Gynecologic Cancer Inter Group (GCIG )Criteria
CA-125 response is defined the percentage of participants with at least 50% reduction in CA-125 levels from pre-treatment sample
Time frame: Up to approximately 3 years and 8 months
Phase 2: Duration of Response as Assessed by Investigator Per RECIST v1.1
DOR is defined as the time from the first determination of a confirmed overall response until the first documentation of progression or death, whichever comes first
Time frame: Up to approximately 3 years and 8 months
Phase 2: Progression Free Survival as Assessed by the Investigator Per RECIST v1.1
PFS is defined as the time from first dose of study medication to the first documented disease progression or death due to any cause, whichever occurs first
Time frame: Up to approximately 3 years and 8 months
Phase 2: Overall Survival (OS) as Assessed by Investigator
OS is defined as time from the first dose of study medication to the date of death due to any cause
Time frame: Up to approximately 3 years and 8 months
Phase 2: Number of Participants With Treatment- Emergent Adverse Events and Serious Adverse Events
A TEAE is defined as an adverse event (AE) that had an onset date on or after the first dose of study drug up to 30 days following study drug discontinuation or was worsening in severity from baseline (pretreatment). All clinically significant abnormalities in physical examinations, laboratory tests and ECGs are reported as adverse events (AE) in the AE section.
Time frame: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Phase 2: Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC0-12)
Time frame: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase 2: Maximum Observed Plasma Concentration (Cmax)
Time frame: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase 2: Time to Reach Cmax (Tmax)
Time frame: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase 2: Area Under the Plasma Concentration-time Curve From 0 to the 9 Hours Post-dose (AUC0-9)
Time frame: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose

Results

Posted Feb 22, 2024

Participant flow

This study consisted of 2 Phases. Phase 1 (December 2016 to December 2019) in which 15 participants were enrolled and Phase 2 (December 2017 to August 2021) in which 113 participants were enrolled. Primary data cut off date for Phase 1 was 24 December 2019 and Primary cut-off date for Phase 2 was 24 August 2020.

Participant flow — Overall Study
Milestone	Phase 1: 20 Milligram (mg) Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib	Phase 2: 60 mg Pamiparib in Platinum-sensitive Ovarian Cancer (PSOC)	Phase 2: 60 mg Pamiparib in Platinum-resistant Ovarian Cancer (PROC)
Started	4	4	7	90	23
Completed	4	3	6	0	0
Not completed	0	1	1	90	23
Withdrew: Lost to follow-up	0	0	1	0	0
Withdrew: Disease progression	0	1	0	0	0
Withdrew: Death	0	0	0	37	18
Withdrew: Sponsor's decision	0	0	0	48	4
Withdrew: Withdrawal by subject	0	0	0	5	1

Outcome measures

PrimaryPhase 1: Number of Participants With Treatment- Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)

Time frame:: From first dose to within 30 days of last dose of pamiparib (approximately 36 months)
Reported as:: Number · Number of participants

Phase 1: Number of Participants With Treatment- Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
Number of participants	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib
Participants with at least 1 TEAE	4	4	7
Treatment-Emergent SAEs	0	1	2

PrimaryPhase 1: Number of Participants With Clinically Significant Abnormalities in Physical Examinations and Electrocardiograms (ECGs)

Time frame:: From first dose to within 30 days of last dose of pamiparib (approximately 36 months)
Reported as:: Number · Number of participants

Phase 1: Number of Participants With Clinically Significant Abnormalities in Physical Examinations and Electrocardiograms (ECGs)
Number of participants	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib
Physical Findings	0	0	0
ECGs	0	0	0

PrimaryPhase 2: Objective Response Rate (ORR) in High Grade Ovarian Cancer (HGOC) Both PSOC and PROC as Assessed by Independent Radiology Review Committee (IRC)

ORR is defined as the percentage of participants with confirmed Complete Response or Partial Response

Time frame:: Up to approximately 2 years and 8 months
Reported as:: Number · Percentage of participants

Phase 2: Objective Response Rate (ORR) in High Grade Ovarian Cancer (HGOC) Both PSOC and PROC as Assessed by Independent Radiology Review Committee (IRC)
Percentage of participants	Phase 2: 60 mg Pamiparib in PSOC	Phase 2: 60 mg Pamiparib in PROC
Phase 2: Objective Response Rate (ORR) in High Grade Ovarian Cancer (HGOC) Both PSOC and PROC as Assessed by Independent Radiology Review Committee (IRC)	68.3 (57.1 to 78.1)	31.6 (12.6 to 56.6)

SecondaryPhase I: Maximum Observed Plasma Concentration (Cmax)

Time frame:: Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Reported as:: Geometric mean · ng/mL

Phase I: Maximum Observed Plasma Concentration (Cmax)
ng/mL	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib
Day 1	718.4 ± 18.9	1633.7 ± 12.2	2302.5 ± 30.1
Day 10	1280.1 ± 70.5	5213.8 ± 25.6	5861.3 ± 29.2

SecondaryPhase I: Time to Reach Cmax (Tmax)

Time frame:: Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Reported as:: Median · hours

Phase I: Time to Reach Cmax (Tmax)
hours	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib
Day 1	1.01 (0.52 to 3.78)	0.98 (0.97 to 1.05)	1.13 (1.00 to 6.08)
Day 10	1.04 (0.92 to 2.12)	1.10 (0.98 to 1.95)	1.13 (0.98 to 1.97)

SecondaryPhase I: Terminal Elimination Half-life (t1/2)

Time frame:: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Reported as:: Geometric mean · hours

Phase I: Terminal Elimination Half-life (t1/2)
hours	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib
Phase I: Terminal Elimination Half-life (t1/2)	12.14 (8.15 to 18.15)	11.79 (8.74 to 20.14)	13.77 (6.54 to 34.91)

SecondaryPhase I: Apparent Clearance (CL/F)

Time frame:: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Reported as:: Geometric mean · Liters/hour (L/h)

Phase I: Apparent Clearance (CL/F)
Liters/hour (L/h)	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib
Phase I: Apparent Clearance (CL/F)	1.95 ± 43.85	2.07 ± 61.09	2.19 ± 79.41

SecondaryPhase 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf)

Time frame:: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Reported as:: Geometric mean · Hours*nanograms/milliliter (h*ng/mL)

Phase 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf)
Hoursnanograms/milliliter (hng/mL)	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib
Phase 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf)	1020.5 ± 43.9	1912.7 ± 61.1	27454.4 ± 79.4

SecondaryPhase I: Apparent Volume of Distribution During Terminal Phase (Vz/F)

Time frame:: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Reported as:: Geometric mean · Liters

Phase I: Apparent Volume of Distribution During Terminal Phase (Vz/F)
Liters	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib
Phase I: Apparent Volume of Distribution During Terminal Phase (Vz/F)	34.2 ± 23.6	35.2 ± 21.8	37.2 ± 33.2

SecondaryPhase I: Confirmed Objective Response Rate (ORR) as Assessed by the Investigator Per RECIST v1.1

ORR is defined as the percentage of participants with confirmed Complete Response (CR) or Partial Response (PR)

Time frame:: Up to approximately 36 months
Reported as:: Number · Percentage of participants

Phase I: Confirmed Objective Response Rate (ORR) as Assessed by the Investigator Per RECIST v1.1
Percentage of participants	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib
Phase I: Confirmed Objective Response Rate (ORR) as Assessed by the Investigator Per RECIST v1.1	25.0 (0.6 to 80.6)	25.0 (0.6 to 80.6)	0 (0.0 to 52.2)

SecondaryPhase 1: Disease Control Rate (DCR) Assessed by the Investigator Per RECIST v1.1

DCR is defined as the percentage of participants with best overall response (BOR) of CR, PR and stable disease (SD)

Time frame:: Up to approximately 36 months
Reported as:: Number · Percentage of participants

Phase 1: Disease Control Rate (DCR) Assessed by the Investigator Per RECIST v1.1
Percentage of participants	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib
Phase 1: Disease Control Rate (DCR) Assessed by the Investigator Per RECIST v1.1	50.0 (6.3 to 93.2)	50.0 (6.8 to 93.2)	80.0 (28.4 to 99.5)

SecondaryPhase I: Clinical Benefit Rate (CBR) Assessed by the Investigator Per RECIST v1.1

CBR is defined as percentage of participants with best overall response of CR, PR and stable disease (SD)≥24 weeks

Time frame:: Up to approximately 36 months
Reported as:: Number · Percentage of participants

Phase I: Clinical Benefit Rate (CBR) Assessed by the Investigator Per RECIST v1.1
Percentage of participants	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib
Phase I: Clinical Benefit Rate (CBR) Assessed by the Investigator Per RECIST v1.1	25.0 (0.6 to 80.6)	50.0 (6.8 to 93.2)	40.0 (5.3 to 85.3)

SecondaryPhase 1: Duration of Response (DOR) as Assessed by Investigator Per RECIST v1.1

DOR is defined as the time from the first determination of a confirmed overall response until the first documentation of progression or death, whichever comes first

Time frame:: Up to approximately 36 months
Reported as:: Median · months

Phase 1: Duration of Response (DOR) as Assessed by Investigator Per RECIST v1.1
months	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib
Phase 1: Duration of Response (DOR) as Assessed by Investigator Per RECIST v1.1	30.4 (NA to NA)	NA (NA to NA)	—

SecondaryPhase I : Progression Free Survival (PFS)

PFS is defined as the time from first dose of study medication to the first documented disease progression or death due to any cause, whichever occurs first

Time frame:: Up to approximately 36 months
Reported as:: Median · Months

Phase I : Progression Free Survival (PFS)
Months	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib
Phase I : Progression Free Survival (PFS)	2.2 (1.48 to 34.53)	NA (1.45 to NA)	5.6 (1.48 to NA)

SecondaryPhase 2: Objective Response Rate (ORR) by Investigator Per RECIST v1.1

ORR is defined as the percentage of participants with confirmed Complete Response or Partial Response

Time frame:: Up to approximately 3 years and 8 months
Reported as:: Number · Percentage of participants

Phase 2: Objective Response Rate (ORR) by Investigator Per RECIST v1.1
Percentage of participants	Phase 2: 60 mg Pamiparib in PSOC	Phase 2: 60 mg Pamiparib in PROC
Phase 2: Objective Response Rate (ORR) by Investigator Per RECIST v1.1	64.6 (53.3 to 74.9)	26.3 (9.1 to 51.2)

SecondaryPhase 2: Disease Control Rate by Investigator Per RECIST v1.1

DCR is defined as the percentage of participants with best overall response (BOR) of CR, PR and stable disease (SD)

Time frame:: Up to approximately 3 years and 8 months
Reported as:: Number · Percentage of participants

Phase 2: Disease Control Rate by Investigator Per RECIST v1.1
Percentage of participants	Phase 2: 60 mg Pamiparib in PSOC	Phase 2: 60 mg Pamiparib in PROC
Phase 2: Disease Control Rate by Investigator Per RECIST v1.1	96.3 (89.7 to 99.2)	78.9 (54.4 to 93.9)

SecondaryPhase 2: Clinical Benefit Rate by Investigator Per RECIST v1.1

CBR is defined as percentage of participants with best overall response of CR, PR and stable disease (SD)≥24 weeks

Time frame:: Up to approximately 3 years and 8 months
Reported as:: Number · Percentage of participants

Phase 2: Clinical Benefit Rate by Investigator Per RECIST v1.1
Percentage of participants	Phase 2: 60 mg Pamiparib in PSOC	Phase 2: 60 mg Pamiparib in PROC
Phase 2: Clinical Benefit Rate by Investigator Per RECIST v1.1	73.2 (62.2 to 82.4)	52.6 (28.0 to 75.6)

SecondaryPhase 2: Carcinoma Antigen-125 (C(A-125) Response Rate by Gynecologic Cancer Inter Group (GCIG )Criteria

CA-125 response is defined the percentage of participants with at least 50% reduction in CA-125 levels from pre-treatment sample

Time frame:: Up to approximately 3 years and 8 months
Reported as:: Number · Percentage of participants

Phase 2: Carcinoma Antigen-125 (C(A-125) Response Rate by Gynecologic Cancer Inter Group (GCIG )Criteria
Percentage of participants	Phase 2: 60 mg Pamiparib in PSOC	Phase 2: 60 mg Pamiparib in PROC
Phase 2: Carcinoma Antigen-125 (C(A-125) Response Rate by Gynecologic Cancer Inter Group (GCIG )Criteria	79.7 (68.8 to 88.2)	38.1 (18.1 to 61.8)

SecondaryPhase 2: Duration of Response as Assessed by Investigator Per RECIST v1.1

DOR is defined as the time from the first determination of a confirmed overall response until the first documentation of progression or death, whichever comes first

Time frame:: Up to approximately 3 years and 8 months
Reported as:: Median · Months

Phase 2: Duration of Response as Assessed by Investigator Per RECIST v1.1
Months	Phase 2: 60 mg Pamiparib in PSOC	Phase 2: 60 mg Pamiparib in PROC
Phase 2: Duration of Response as Assessed by Investigator Per RECIST v1.1	11.1 (9.00 to 14.52)	6.9 (4.93 to 19.78)

SecondaryPhase 2: Progression Free Survival as Assessed by the Investigator Per RECIST v1.1

PFS is defined as the time from first dose of study medication to the first documented disease progression or death due to any cause, whichever occurs first

Time frame:: Up to approximately 3 years and 8 months
Reported as:: Median · Months

Phase 2: Progression Free Survival as Assessed by the Investigator Per RECIST v1.1
Months	Phase 2: 60 mg Pamiparib in PSOC	Phase 2: 60 mg Pamiparib in PROC
Phase 2: Progression Free Survival as Assessed by the Investigator Per RECIST v1.1	10.4 (8.31 to 15.15)	5.5 (2.27 to 6.24)

SecondaryPhase 2: Overall Survival (OS) as Assessed by Investigator

OS is defined as time from the first dose of study medication to the date of death due to any cause

Time frame:: Up to approximately 3 years and 8 months
Reported as:: Median · Months

Phase 2: Overall Survival (OS) as Assessed by Investigator
Months	Phase 2: 60 mg Pamiparib in PSOC	Phase 2: 60 mg Pamiparib in PROC
Phase 2: Overall Survival (OS) as Assessed by Investigator	34.1 (29.08 to NA)	13.6 (7.13 to 19.75)

SecondaryPhase 2: Number of Participants With Treatment- Emergent Adverse Events and Serious Adverse Events

A TEAE is defined as an adverse event (AE) that had an onset date on or after the first dose of study drug up to 30 days following study drug discontinuation or was worsening in severity from baseline (pretreatment). All clinically significant abnormalities in physical examinations, laboratory tests and ECGs are reported as adverse events (AE) in the AE section.

Time frame:: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Reported as:: Number · Number of participants

Phase 2: Number of Participants With Treatment- Emergent Adverse Events and Serious Adverse Events
Number of participants	Phase 2: 60 mg Pamiparib in PSOC	Phase 2: 60 mg Pamiparib in PROC
Participants With At Least one TEAE	90	23
Treatment Emergent SAEs	36	15

SecondaryPhase 2: Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC0-12)

Time frame:: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Reported as:: Geometric mean · hours*nanograms/milliliter (h*ng/mL)

Phase 2: Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC0-12)
hoursnanograms/milliliter (hng/mL)	Phase 2: 60 mg Pamiparib in PSOC or PROC
Cycle 1 Day 1	16841.5 ± 20.5
Cycle 2 Day 1	48802.4 ± 24.3

SecondaryPhase 2: Maximum Observed Plasma Concentration (Cmax)

Time frame:: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Reported as:: Geometric mean · ng/mL

Phase 2: Maximum Observed Plasma Concentration (Cmax)
ng/mL	Phase 2: 60 mg Pamiparib in PSOC or PROC
Cycle 1Day 1	2275.1 ± 19.6
Cycle 2 Day 1	5251.5 ± 22.7

SecondaryPhase 2: Time to Reach Cmax (Tmax)

Time frame:: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Reported as:: Median · hours

Phase 2: Time to Reach Cmax (Tmax)
hours	Phase 2: 60 mg Pamiparib in PSOC or PROC
Cycle 1 Day 1	1.88 (0.95 to 3.98)
Cycle 2 Day 1	1.98 (0.50 to 4.00)

SecondaryPhase 2: Area Under the Plasma Concentration-time Curve From 0 to the 9 Hours Post-dose (AUC0-9)

Time frame:: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Reported as:: Geometric mean · h*ng/mL

Phase 2: Area Under the Plasma Concentration-time Curve From 0 to the 9 Hours Post-dose (AUC0-9)
h*ng/mL	Phase 2: 60 mg Pamiparib in PSOC or PROC
Cycle 1 Day 1	13577.2 ± 20.3
Cycle 2 Day 1	38259.3 ± 23.5

Adverse events

Collected over Phase1: From first dose to within 30 days of last dose of pamiparib (approximately 36 months) Phase 2: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months). Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Phase 1: 20 mg Pamiparib	0/4 (0%)	0/4 (0%)	4/4 (100%)
Phase 1: 40 mg Pamiparib	0/4 (0%)	1/4 (25%)	4/4 (100%)
Phase 1: 60 mg Pamiparib	0/7 (0%)	2/7 (28.6%)	7/7 (100%)
Phase 2: 60 mg Pamiparib in Platinum-sensitive Ovarian Cancer (PSOC)	37/90 (41.1%)	36/90 (40%)	90/90 (100%)
Phase 2: 60 mg Pamiparib in Platinum-resistant Ovarian Cancer (PROC)	18/23 (78.3%)	15/23 (65.2%)	22/23 (95.7%)

Most frequent serious events

Showing 10 of 31

Most frequent serious events
Event	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib	Phase 2: 60 mg Pamiparib in Platinum-sensitive Ovarian Cancer (PSOC)	Phase 2: 60 mg Pamiparib in Platinum-resistant Ovarian Cancer (PROC)
AnaemiaBlood and lymphatic system disorders	0/4	0/4	0/7	16/90	7/23
Pleural effusionRespiratory, thoracic and mediastinal disorders	0/4	1/4	0/7	1/90	1/23
Intestinal obstructionGastrointestinal disorders	0/4	0/4	1/7	2/90	1/23
Abdominal infectionInfections and infestations	0/4	0/4	1/7	1/90	0/23
PancytopeniaBlood and lymphatic system disorders	0/4	0/4	0/7	0/90	2/23
AscitesGastrointestinal disorders	0/4	0/4	0/7	2/90	2/23
Neutrophil count decreasedInvestigations	0/4	0/4	0/7	4/90	0/23
Abdominal painGastrointestinal disorders	0/4	0/4	0/7	1/90	1/23
IleusGastrointestinal disorders	0/4	0/4	0/7	1/90	1/23
Large intestine perforationGastrointestinal disorders	0/4	0/4	0/7	0/90	1/23

Most frequent other events

Showing 10 of 131

Most frequent other events
Event	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib	Phase 2: 60 mg Pamiparib in Platinum-sensitive Ovarian Cancer (PSOC)	Phase 2: 60 mg Pamiparib in Platinum-resistant Ovarian Cancer (PROC)
NauseaGastrointestinal disorders	4/4	3/4	5/7	61/90	16/23
AstheniaGeneral disorders	3/4	4/4	5/7	26/90	6/23
AnaemiaBlood and lymphatic system disorders	1/4	1/4	2/7	81/90	21/23
Neutrophil count decreasedInvestigations	1/4	3/4	4/7	57/90	13/23
White blood cell count decreasedInvestigations	2/4	3/4	5/7	55/90	14/23
Decreased appetiteMetabolism and nutrition disorders	3/4	3/4	3/7	30/90	5/23
HyponatraemiaMetabolism and nutrition disorders	3/4	0/4	1/7	4/90	1/23
TachycardiaCardiac disorders	0/4	2/4	5/7	0/90	0/23
Haemoglobin decreasedInvestigations	0/4	1/4	5/7	0/90	0/23
VomitingGastrointestinal disorders	1/4	2/4	2/7	46/90	11/23

Baseline characteristics

Safety Analysis Set includes all participants who received at least one dose of pamiparib

Age, Continuous
Age, Continuous(years)	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib	Phase 2: 60 mg Pamiparib in PSOC	Phase 2: 60 mg Pamiparib in PROC	Total
Mean	53.5 ± 6.55	48.0 ± 13.95	53.0 ± 9.15	54.4 ± 7.94	52.9 ± 7.97	53.87 ± 8.14

Sex: Female, Male
Sex: Female, Male(Participants)	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib	Phase 2: 60 mg Pamiparib in PSOC	Phase 2: 60 mg Pamiparib in PROC	Total
Female	4	4	7	90	23	128
Male	0	0	0	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib	Phase 2: 60 mg Pamiparib in PSOC	Phase 2: 60 mg Pamiparib in PROC	Total
Hispanic or Latino	0	0	0	0	0	0
Not Hispanic or Latino	4	4	7	90	23	128
Unknown or Not Reported	0	0	0	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Phase 1: 20 mg Pamiparib	Phase 1: 40 mg Pamiparib	Phase 1: 60 mg Pamiparib	Phase 2: 60 mg Pamiparib in PSOC	Phase 2: 60 mg Pamiparib in PROC	Total
Asian	4	4	7	90	23	128

Study locations

6 sites

Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality 100021, China
Beijing Cancer Hospital
Beijing, Beijing Municipality 100142, China
Henan Cancer Hospital
Zhengzhou, Henan 450000, China
Hunan Cancer Hospital
Changsha, Hunan 410013, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality 200000, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang 310022, China

References and documents

Study documents

Study protocol · Sep 21, 2018
Statistical analysis plan · Feb 28, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03333915
Lead sponsor: BeiGene
Responsible party: Sponsor
First posted: Nov 7, 2017
Start date: Dec 21, 2016
Primary completion: Aug 24, 2020
Completion: Aug 11, 2021
Results posted: Feb 22, 2024
Last update: Feb 4, 2025

Study contacts

Study Director

principal investigator · BeiGene

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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