Multiple clinical trials evaluate the therapeutic profile of saruparib (AZD5305) across various oncology indications, including advanced breast cancer, metastatic castration-sensitive prostate cancer, ovarian cancer, small cell lung carcinoma, and pancreatic ductal adenocarcinoma. Spanning from Early Phase 1 to Phase 3, these studies are sponsored by AstraZeneca alongside academic entities such as the SWOG Cancer Research Network, OHSU Knight Cancer Institute, and the University of Leeds. Across these protocols, recruitment statuses currently encompass active recruiting, active not recruiting, completed, and withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06952803 | RECRUITING | Prostate Cancer |
AstraZeneca |
2025-08-06 | PHASE3 |
| NCT07711002 | NOT_YET_RECRUITING | Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) |
AstraZeneca |
2026-10-01 | PHASE3 |
| NCT05367440 | ACTIVE_NOT_RECRUITING | Metastatic Prostate Cancer |
AstraZeneca |
2022-06-02 | PHASE1; PHASE2 |
| NCT07446855 | RECRUITING | Solid Tumours |
AstraZeneca |
2026-03-17 | PHASE1; PHASE2 |
| NCT06380751 | RECRUITING | Advanced Breast Cancer |
AstraZeneca |
2024-08-01 | PHASE3 |
| NCT07336446 | RECRUITING | Prostate Cancer |
AstraZeneca |
2026-01-27 | PHASE1; PHASE2 |
| NCT06769126 | RECRUITING | Extensive Stage Lung Small Cell Carcinoma; Lung Small Cell Carcinoma, A Subtype; Lung Small Cell Carcinoma, I Subtype; Lung Small Cell Carcinoma, N Subtype; Lung Small Cell Carcinoma, P Subtype |
SWOG Cancer Research Network |
2025-11-06 | PHASE2 |
| NCT05797168 | RECRUITING | Ovarian Cancer; Lung Adenocarcinoma; Endometrial Cancer; Lung Squamous Cell Carcinoma |
AstraZeneca |
2023-06-05 | PHASE1; PHASE2 |
| NCT06120491 | ACTIVE_NOT_RECRUITING | Metastatic Castration-Sensitive Prostate Cancer |
AstraZeneca |
2023-11-21 | PHASE3 |
| NCT05123482 | RECRUITING | Breast Cancer; Biliary Tract Carcinoma; Ovarian Cancer; Endometrial Cancer; Squamous Non-Small Cell Lung Cancer |
AstraZeneca |
2021-10-18 | PHASE1; PHASE2 |
| NCT04005690 | RECRUITING | Locally Advanced Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Ductal Adenocarcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Ductal Adenocarcinoma; Borderline Resectable Pancreatic Ductal Adenocarcinoma; Resectable Pancreatic Ductal Adenocarcinoma |
OHSU Knight Cancer Institute |
2019-08-01 | EARLY_PHASE1 |
| NCT04644068 | ACTIVE_NOT_RECRUITING | Ovarian Cancer; Breast Cancer; Pancreatic Cancer; Prostate Cancer; Additional Indications Below for Module 4 and 5; Non-small Cell Lung Cancer; Colorectal Cancer; Bladder Cancer; Gastric Cancer; Biliary Cancer; Cervical Cancer; Endometrial Cancer; Small Cell Lung Cancer Only in Module 5 |
AstraZeneca |
2020-11-12 | PHASE1; PHASE2 |
| NCT06713369 | RECRUITING | Locally Advanced or Metastatic Solid Tumor |
AstraZeneca |
2025-04-02 | PHASE1 |
| NCT05938270 | COMPLETED | Prostate Cancer |
AstraZeneca |
2023-09-21 | PHASE1 |
| NCT04550104 | RECRUITING | Non Small Cell Lung Cancer |
University of Leeds |
2021-03-17 | PHASE1 |
| NCT06899061 | ACTIVE_NOT_RECRUITING | Advanced Solid Malignancies |
AstraZeneca |
2025-03-25 | PHASE1 |
| NCT07060365 | WITHDRAWN | Advanced/Recurrent Ovarian Cancer |
AstraZeneca |
2025-09-02 | PHASE1; PHASE2 |
| NCT02264678 | ACTIVE_NOT_RECRUITING | Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer |
AstraZeneca |
2014-10-31 | PHASE1 |
| NCT05797168 | Recruiting | Ovarian Cancer|Lung Adenocarcinoma |
AstraZeneca |
2023-06-05 | Phase 1|Phase 2 |
| NCT05573724 | COMPLETED | Advanced Solid Malignancies |
AstraZeneca |
2022-11-07 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-08-21)
Check the
AZD5305 (Saruparib)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
Note: Technical data last updated: Sep 1, 2026.