Phase 2
Completed N=128
Study of the Efficacy, Safety and Pharmacokinetics of Pamiparib (BGB-290) in Participants With Advanced Solid Tumors
Source: ClinicalTrials.gov NCT03333915 ↗Enrolled (actual)
128
Serious AEs
42.2%
Results posted
Feb 2024
Primary outcomePrimary: Phase 1: Number of Participants With Treatment- Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) — 4; 4; 7; 0 Number of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1: Number of Participants With Treatment- Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) |
4; 4; 7; 0; 1; 2 | — |
| PRIMARY Phase 1: Number of Participants With Clinically Significant Abnormalities in Physical Examinations and Electrocardiograms (ECGs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 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; 31.6 | — |
| SECONDARY Phase I: Maximum Observed Plasma Concentration (Cmax) |
718.4; 1633.7; 2302.5; 1280.1; 5213.8; 5861.3 | — |
| SECONDARY Phase I: Time to Reach Cmax (Tmax) |
1.01; 0.98; 1.13; 1.04; 1.10; 1.13 | — |
| SECONDARY Phase I: Terminal Elimination Half-life (t1/2) |
12.14; 11.79; 13.77 | — |
| SECONDARY Phase I: Apparent Clearance (CL/F) |
1.95; 2.07; 2.19 | — |
| SECONDARY Phase 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) |
1020.5; 1912.7; 27454.4 | — |
| SECONDARY Phase I: Apparent Volume of Distribution During Terminal Phase (Vz/F) |
34.2; 35.2; 37.2 | — |
| SECONDARY Phase I: Confirmed Objective Response Rate (ORR) as Assessed by the Investigator Per RECIST v1.1 |
25.0; 25.0; 0 | — |
| SECONDARY Phase 1: Disease Control Rate (DCR) Assessed by the Investigator Per RECIST v1.1 |
50.0; 50.0; 80.0 | — |
| SECONDARY Phase I: Clinical Benefit Rate (CBR) Assessed by the Investigator Per RECIST v1.1 |
25.0; 50.0; 40.0 | — |
| SECONDARY Phase 1: Duration of Response (DOR) as Assessed by Investigator Per RECIST v1.1 |
30.4; NA | — |
| SECONDARY Phase I : Progression Free Survival (PFS) |
2.2; NA; 5.6 | — |
| SECONDARY Phase 2: Objective Response Rate (ORR) by Investigator Per RECIST v1.1 |
64.6; 26.3 | — |
| SECONDARY Phase 2: Disease Control Rate by Investigator Per RECIST v1.1 |
96.3; 78.9 | — |
| SECONDARY Phase 2: Clinical Benefit Rate by Investigator Per RECIST v1.1 |
73.2; 52.6 | — |
| SECONDARY Phase 2: Carcinoma Antigen-125 (C(A-125) Response Rate by Gynecologic Cancer Inter Group (GCIG )Criteria |
79.7; 38.1 | — |
| SECONDARY Phase 2: Duration of Response as Assessed by Investigator Per RECIST v1.1 |
11.1; 6.9 | — |
| SECONDARY Phase 2: Progression Free Survival as Assessed by the Investigator Per RECIST v1.1 |
10.4; 5.5 | — |
| SECONDARY Phase 2: Overall Survival (OS) as Assessed by Investigator |
34.1; 13.6 | — |
| SECONDARY Phase 2: Number of Participants With Treatment- Emergent Adverse Events and Serious Adverse Events |
90; 23; 36; 15 | — |
| SECONDARY Phase 2: Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC0-12) |
16841.5; 48802.4 | — |
| SECONDARY Phase 2: Maximum Observed Plasma Concentration (Cmax) |
2275.1; 5251.5 | — |
| SECONDARY Phase 2: Time to Reach Cmax (Tmax) |
1.88; 1.98 | — |
| SECONDARY Phase 2: Area Under the Plasma Concentration-time Curve From 0 to the 9 Hours Post-dose (AUC0-9) |
13577.2; 38259.3 | — |
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.
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT03333915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.