Pamiparib is currently undergoing evaluation across numerous clinical trials spanning Early Phase 1 through Phase 3 for indications including epithelial ovarian cancer, platinum-resistant ovarian carcinoma, advanced solid tumors, non-small-cell lung cancer, and metastatic castration-resistant prostate cancer. Sponsored by both pharmaceutical industry leaders like BeiGene and academic medical centers, these protocols encompass various statuses, including completed, active recruiting, active non-recruiting, pending, and withdrawn. Together, these studies underscore the broad therapeutic potential of pamiparib in monotherapy and combination regimens for advanced malignancies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05526924 | RECRUITING | Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma; Head and Neck Carcinoma; Head and Neck Cancer Stage IV; Head and Neck Cancers - Throat |
University of Chicago |
2023-03-07 | PHASE1 |
| NCT06692491 | NOT_YET_RECRUITING | Rare Tumour |
Peking University Shenzhen Hospital |
2025-01-01 | PHASE2 |
| NCT04796454 | WITHDRAWN | Platinum-Sensitive Biliary Tract Cancer |
European Organisation for Research and Treatment of Cancer - EORTC |
2022-05 | PHASE2 |
| NCT04164199 | COMPLETED | Advanced Malignancies |
BeOne Medicines |
2019-12-19 | PHASE3 |
| NCT05038839 | COMPLETED | Advanced Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm |
M.D. Anderson Cancer Center |
2022-02-09 | PHASE1 |
| NCT06387056 | RECRUITING | Locally Advanced Prostate Cancer; Oligometastatic Prostate Cancer |
The First Affiliated Hospital of Xiamen University |
2024-04-01 | PHASE2 |
| NCT03519230 | ACTIVE_NOT_RECRUITING | Ovarian Cancer |
BeiGene |
2018-05-14 | PHASE3 |
| NCT04985721 | UNKNOWN | Cancer |
Peter MacCallum Cancer Centre, Australia |
2022-02-24 | PHASE2 |
| NCT05327621 | UNKNOWN | Metastatic Castration-resistant Prostate Cancer |
Sun Yat-sen University |
2022-05-01 | PHASE2 |
| NCT05044871 | COMPLETED | Ovarian Cancer |
Tongji Hospital |
2022-07-22 | PHASE2 |
| NCT05483543 | UNKNOWN | Limited Stage Small Cell Lung Cancer |
Fudan University |
2022-06-20 | PHASE2 |
| NCT05573373 | UNKNOWN | Carcinoma, Non-Small-Cell Lung; EGF-R Positive Non-Small Cell Lung Cancer |
Affiliated Hospital of Jiangnan University |
2022-12-20 | PHASE1 |
| NCT05669768 | UNKNOWN | Ovarian Cancer |
Sun Yat-sen University |
2023-01-01 | PHASE2 |
| NCT05494580 | COMPLETED | Ovarian Cancer; Ovarian Carcinoma; Platinum-resistant Ovarian Cancer; Fallopian Tube Carcinosarcoma; Primary Peritoneal Cancer |
Sun Yat-sen University |
2022-09-22 | PHASE1; PHASE2 |
| NCT05489926 | UNKNOWN | Epithelial Ovarian Cancer |
Zhejiang Cancer Hospital |
2022-08-16 | PHASE2 |
| NCT05652283 | ACTIVE_NOT_RECRUITING | Ovarian Cancer |
Bai-Rong Xia |
2022-11-06 | PHASE2 |
| NCT05376722 | UNKNOWN | Neoadjuvant Therapy |
Hongqian Guo |
2022-02-22 | PHASE2 |
| NCT04614909 | COMPLETED | Glioblastoma; Glioblastoma Multiforme; Glioblastoma Multiforme, Adult |
Nader Sanai |
2021-01-11 | EARLY_PHASE1 |
| NCT04603365 | WITHDRAWN | Clear Cell Papillary Renal Neoplasm; Collecting Duct Carcinoma; Hereditary Leiomyomatosis and Renal Cell Carcinoma; Hereditary Papillary Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma; Metastatic Unclassified Renal Cell Carcinoma; Papillary Renal Cell Carcinoma; Stage III Renal Cell Cancer American Joint Committee on Cancer (AJCC) v8; Stage IV Renal Cell Cancer AJCC v8; Tubulocystic Renal Cell Carcinoma; Unresectable Renal Cell Carcinoma |
Jonsson Comprehensive Cancer Center |
2021-10-18 | PHASE2 |
| NCT03150810 | COMPLETED | Locally Advanced or Metastatic Solid Tumors |
BeiGene |
2017-06-28 | PHASE1 |
| NCT05376722 | Recruiting | Neoadjuvant Therapy |
Hongqian Guo|First Affiliated Hospital of Zhejiang University|The First Affiliated Hospital of Soochow University|Nanjing First Hospital Nanjing Medical University|The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
2022-02-22 | Phase 2 |
| NCT04985721 | Recruiting | Cancer |
Peter MacCallum Cancer Centre Australia |
2022-02-24 | Phase 2 |
| NCT03933761 | WITHDRAWN | Ovarian Cancer; Carcinosarcoma |
Australia New Zealand Gynaecological Oncology Group |
2019-07-29 | PHASE2 |
| NCT03150862 | COMPLETED | Brain and Central Nervous System Tumors |
BeiGene USA, Inc. |
2017-07-24 | PHASE1; PHASE2 |
| NCT02660034 | COMPLETED | Solid Tumors |
BeiGene |
2016-02-02 | PHASE1 |
| NCT03333915 | COMPLETED | Advanced High-grade Ovarian Cancer; Triple Negative Breast Cancer |
BeiGene |
2016-12-21 | PHASE1; PHASE2 |
| NCT03712930 | TERMINATED | Metastatic Castration-Resistant Prostate Cancer (mCRPC); Homologous Recombination Deficiency (HRD) |
BeiGene |
2019-02-05 | PHASE2 |
| NCT03427814 | COMPLETED | Advanced or Inoperable Gastric Cancer |
BeiGene |
2018-07-03 | PHASE2 |
| NCT03994211 | COMPLETED | Solid Tumor |
BeiGene |
2019-05-29 | PHASE1 |
| NCT03991494 | COMPLETED | Advanced Solid Tumors |
BeiGene |
2019-05-29 | PHASE1 |
| NCT03991494 | Completed | Advanced Solid Tumors |
BeiGene |
2019-05-29 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-03-04)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).