Clinical Trials

Rucaparib is being evaluated across numerous clinical trials ranging from Early Phase 1 to Phase 3 investigations, including the ATHENA study, primarily targeting advanced ovarian, fallopian tube, primary peritoneal, breast, prostate, and small cell lung cancers. Sponsored by pharmaceutical companies, academic medical centers, and cooperative groups, these studies assess rucaparib as both monotherapy and combination therapy. The research landscape encompasses various recruitment statuses, including completed, active non-recruiting, recruiting, and terminated protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03899155 RECRUITING
Cancer
Bristol-Myers Squibb
 2019-08-09 PHASE2
NCT03768063 ACTIVE_NOT_RECRUITING
Cancer
Hoffmann-La Roche
 2019-02-28 PHASE3
NCT02925234 RECRUITING
Cancer; Tumors; Neoplasm; Neoplasia
The Netherlands Cancer Institute
 2016-08 PHASE2
NCT04455750 ACTIVE_NOT_RECRUITING
Castration-Resistant Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8
Alliance for Clinical Trials in Oncology
 2021-10-14 PHASE3
NCT04253262 ACTIVE_NOT_RECRUITING
Metastatic Castration-resistant Prostate Cancer
Brown University
 2020-04-03 PHASE1; PHASE2
NCT04624178 ACTIVE_NOT_RECRUITING
Leiomyosarcoma
Memorial Sloan Kettering Cancer Center
 2020-11-05 PHASE2
NCT03442556 TERMINATED
ATM Gene Mutation; BRCA1 Gene Mutation; BRCA2 Gene Mutation; Castration Levels of Testosterone; Castration-Resistant Prostate Carcinoma; Homologous Recombination Deficiency; Prostate Carcinoma Metastatic in the Bone; PSA Level Greater Than or Equal to Two; PSA Progression; Stage IV Prostate Adenocarcinoma AJCC v7
University of Washington
 2018-08-24 PHASE2
NCT03559049 TERMINATED
Stage IV Non-small Cell Lung Cancer
University of Michigan Rogel Cancer Center
 2018-12-24 PHASE1; PHASE2
NCT02678182 ACTIVE_NOT_RECRUITING
Adenocarcinoma of the Oesophagus; Adenocarcinoma of the Gastro-oesophageal Junction; Adenocarcinoma of the Stomach
Royal Marsden NHS Foundation Trust
 2015-02 PHASE2
NCT03462212 UNKNOWN
Advanced (Stage IIIB-C-IV) Ovarian, Primary Peritoneal and Fallopian Tube Cancer
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
 2021-03-17 PHASE1; PHASE2
NCT02873962 ACTIVE_NOT_RECRUITING
Peritoneal Cancer; Ovarian Cancer; Fallopian Tube Cancer
Dana-Farber Cancer Institute
 2016-11-10 PHASE2
NCT03542175 COMPLETED
Breast Cancer
Memorial Sloan Kettering Cancer Center
 2018-05-23 PHASE1
NCT03522246 ACTIVE_NOT_RECRUITING
Epithelial Ovarian Cancer; Primary Peritoneal; Fallopian Tube Cancer; Newly Diagnosed; FIGO Stage III-IV; Partial Response; Complete Response
pharmaand GmbH
 2018-05-14 PHASE3
NCT04826198 TERMINATED
Ovarian Cancer
Gustave Roussy, Cancer Campus, Grand Paris
 2020-10-05 PHASE1; PHASE2
NCT04227522 COMPLETED
Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer; Clear Cell Carcinoma
North Eastern German Society of Gynaecological Oncology
 2020-06-08 PHASE3
NCT03413995 COMPLETED
Prostate Cancer Metastatic
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2018-09-10 PHASE2
NCT03617679 COMPLETED
Metastatic Endometrial Cancer
University of Colorado, Denver
 2019-03-06 PHASE2
NCT03694262 COMPLETED
Endometrial Cancer; Uterine Carcinosarcoma
Medical College of Wisconsin
 2019-07-19 PHASE2
NCT04676334 COMPLETED
Metastatic Castration-Resistant Prostate Cancer; Ovarian Cancer; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer; Other Solid Tumor
pharmaand GmbH
 2021-03-22 PHASE3
NCT03654833 COMPLETED
Mesothelioma, Malignant
University of Leicester
 2019-01-28 PHASE2
NCT03639935 COMPLETED
Biliary Tract Cancer
University of Michigan Rogel Cancer Center
 2019-03-28 PHASE2
NCT04276376 TERMINATED
Solid Tumor
Gustave Roussy, Cancer Campus, Grand Paris
 2019-04-12 PHASE2
NCT03533946 TERMINATED
Prostate Cancer
University of Utah
 2019-05-20 PHASE2
NCT03958045 COMPLETED
Small Cell Lung Cancer
Zhonglin Hao
 2019-09-04 PHASE2
NCT03995017 UNKNOWN
Esophagus Cancer, Adenocarcinoma; Stomach Cancer, Adenocarcinoma
University of Kansas Medical Center
 2020-01-09 PHASE1; PHASE2
NCT02975934 COMPLETED
Metastatic Castration Resistant Prostate Cancer
pharmaand GmbH
 2017-06-13 PHASE3
NCT03552471 COMPLETED
BRCA1 Gene Mutation; BRCA2 Gene Mutation; Folate Receptor Alpha Positive; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Recurrent Uterine Corpus Carcinoma; Recurrent Uterine Serous Carcinoma; Recurrent Uterine Carcinosarcoma; Platinum Resistant Ovarian Cancer
Ohio State University Comprehensive Cancer Center
 2018-07-12 PHASE1
NCT04171700 TERMINATED
Solid Tumor
pharmaand GmbH
 2020-01-16 PHASE2
NCT02935634 COMPLETED
Advanced Gastric Cancer
Bristol-Myers Squibb
 2016-11-29 PHASE2
NCT03992131 TERMINATED
Ovarian Cancer; Triple-negative Breast Cancer; Urothelial Carcinoma; Solid Tumor
pharmaand GmbH
 2019-06-28 PHASE1; PHASE2
NCT03845296 COMPLETED
Deleterious BRCA1 Gene Mutation; Deleterious BRCA2 Gene Mutation; Loss of Heterozygosity; Lung Non-Small Cell Squamous Carcinoma; Recurrent Large Cell Lung Carcinoma; Recurrent Lung Adenocarcinoma; Recurrent Lung Non-Small Cell Carcinoma; Recurrent Non-Squamous Non-Small Cell Lung Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8
SWOG Cancer Research Network
 2019-04-16 PHASE2
NCT03840200 COMPLETED
Breast Cancer; Prostate Cancer; Ovarian Cancer
Hoffmann-La Roche
 2019-06-12 PHASE1
NCT04179396 COMPLETED
Metastatic Castration Resistant Prostate Cancer
pharmaand GmbH
 2019-12-05 PHASE1
NCT04209595 COMPLETED
Small Cell Lung Cancer; Extra-Pulmonary Small Cell Carcinomas
National Cancer Institute (NCI)
 2020-04-08 PHASE1; PHASE2
NCT02952534 COMPLETED
Metastatic Castration Resistant Prostate Cancer
pharmaand GmbH
 2017-02-15 PHASE2
NCT03911453 COMPLETED
Breast Cancer
University of Arizona
 2019-04-19 EARLY_PHASE1
NCT03337087 UNKNOWN
Metastatic Biliary Tract Carcinoma; Metastatic Colorectal Carcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Metastatic Malignant Digestive System Neoplasm; Metastatic Pancreatic Adenocarcinoma; Stage IV Colorectal Cancer AJCC v7; Stage IV Pancreatic Cancer AJCC v6 and v7; Stage IVA Colorectal Cancer AJCC v7; Stage IVB Colorectal Cancer AJCC v7
Academic and Community Cancer Research United
 2018-11-02 PHASE1; PHASE2
NCT03318445 COMPLETED
Solid Tumor, Unspecified, Adult
Pamela Munster
 2018-01-12 PHASE1
NCT03338790 COMPLETED
Prostate Cancer
Bristol-Myers Squibb
 2017-12-19 PHASE2
NCT02855944 COMPLETED
Ovarian Cancer; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
pharmaand GmbH
 2017-03-01 PHASE3
NCT03140670 TERMINATED
Pancreatic Cancer
Abramson Cancer Center at Penn Medicine
 2017-09-05 PHASE2
NCT03824704 TERMINATED
Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; High Grade Serous Carcinoma; Endometrioid Adenocarcinoma
pharmaand GmbH
 2019-08-23 PHASE2
NCT03101280 COMPLETED
Gynecologic Neoplasms
Hoffmann-La Roche
 2017-04-27 PHASE1
NCT04539327 Completed
Epithelial Ovarian Cancer|Fallopian Tube Cancer|Primary Peritoneal Cancer
Grupo Español de Investigación en Cáncer de Ovario|Clovis Oncology Inc.
 2020-07-29 --
NCT03476798 COMPLETED
Cervical Cancer; Endometrial Cancer
University of Oklahoma
 2018-06-29 PHASE2
NCT04209595 Active not recruiting
Small Cell Lung Cancer|Extra-Pulmonary Small Cell Carcinomas
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC)
 2020-04-08 Phase 1|Phase 2
NCT03572478 TERMINATED
Prostate Cancer; Endometrial Cancer
University of Chicago
 2018-08-14 PHASE1; PHASE2
NCT03397394 TERMINATED
Bladder Cancer; Urothelial Carcinoma; Metastatic Urothelial Carcinoma; Renal Pelvis Carcinoma; Ureter Carcinoma; Urinary Bladder Carcinoma; Urethra Carcinoma; Muscle Invasive Bladder Cancer
pharmaand GmbH
 2018-06-01 PHASE2
NCT03954366 COMPLETED
Neoplasms
pharmaand GmbH
 2019-04-25 PHASE1
NCT04179396 Completed
Metastatic Castration Resistant Prostate Cancer
pharmaand GmbH
 2019-12-05 Phase 1
NCT01891344 COMPLETED
Ovarian Cancer; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
pharmaand GmbH
 2013-10-30 PHASE2
NCT03795272 WITHDRAWN
Cervical Cancer
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
 2019-10-01 PHASE2
NCT03521037 COMPLETED
Neoplasms
pharmaand GmbH
 2018-02-27 PHASE1
NCT03824704 Terminated
Epithelial Ovarian Cancer|Fallopian Tube Cancer|Primary Peritoneal Carcinoma|High Grade Serous Carcinoma|Endometrioid Adenocarcinoma
pharmaand GmbH|Bristol-Myers Squibb|Foundation Medicine
 2019-08-23 Phase 2
NCT03499444 COMPLETED
Advanced Solid Tumor
pharmaand GmbH
 2018-02-06 PHASE1
NCT03840200 Completed
Breast Cancer|Prostate Cancer|Ovarian Cancer
Hoffmann-La Roche
 2019-06-12 Phase 1
NCT01482715 COMPLETED
Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer; Advanced Solid Tumor With Evidence of Germline or Somatic BRCA
pharmaand GmbH
 2011-11 PHASE1; PHASE2
NCT02711137 TERMINATED
Solid Tumors
Incyte Corporation
 2016-05-18 PHASE1; PHASE2
NCT02505048 COMPLETED
Metastatic Breast Cancer
UNICANCER
 2016-03 PHASE2
NCT01074970 COMPLETED
Breast Cancer
Hoosier Cancer Research Network
 2010-02 PHASE2
NCT02986100 COMPLETED
Solid Tumor
pharmaand GmbH
 2016-11 PHASE1
NCT01968213 COMPLETED
Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
pharmaand GmbH
 2014-04-07 PHASE3
NCT02740712 COMPLETED
Neoplasms
pharmaand GmbH
 2016-04 PHASE1
NCT02042378 COMPLETED
Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma
pharmaand GmbH
 2014-04 PHASE2
NCT00664781 COMPLETED
brca1 Mutation Carrier; brca2 Mutation Carrier; Breast Cancer; Ovarian Cancer
Cancer Research UK
 2007-12 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-29)

Check the Rucaparib (AG-014699) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rucaparib acts as a potent inhibitor of poly (ADP-ribose) polymerase (PARP), binding to PARP1 with an inhibition constant (Ki) of 1.4 nM in cell-free assays while exhibiting binding affinity across eight additional PARP catalytic domains. By suppressing PARP enzymatic activity and hindering single-strand DNA break repair, rucaparib induces genomic instability and synthetic lethality in homologous recombination-deficient cells, resulting in potent antitumor activity across clinical indications including epithelial ovarian, fallopian tube, primary peritoneal, breast, and prostate cancers.

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>).

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Note: Technical data last updated: Sep 1, 2026.