Summary
Olaparib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Cancer. ClinicalTrials.gov lists 8 registered trials linking Olaparib to Cancer: 3 are currently recruiting; 1 is active or not yet recruiting; 4 have completed. The most advanced is Phase 3 (NCT03784014). It plans or enrolled 603 participants. Registration activity spans 2015 to 2026. The literature layer holds 15 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2025 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Cancer ranks 1226 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous regression is rare (<0.5% of cases); 5-year survival without treatment: <5% for advanced NSCLC; ~20% for stage I-II with surgery.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 76.0 (trials 26.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 3 recruiting, 1 active / not yet recruiting, 4 completed, 0 other |
| Linked publications | 15 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 2 randomised controlled trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT03784014 | Molecular Profiling of Advanced Soft-tissue Sarcomas 2019 | completed | Phase 3 | 603 |
| NCT05005728 | XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer 2021 | completed | Phase 2 | 72 |
| NCT07018622 | Protecting the Kidney's Proximal Tubules From Platinum-Based Chemotherapy Toxicity 2025 | recruiting | Phase 2 | 46 |
| NCT03057145 | Combination Study of Prexasertib and Olaparib in Patients With Advanced Solid Tumors 2017 | completed | Phase 1 | 29 |
| NCT02430311 | The Pharmacokinetics and Safety of Olaparib Alone and With Paclitaxel in Chinese Patients With Advanced Solid Tumour. 2015 | completed | Phase 1 | 36 |
| NCT07637851 | Safety and Efficacy of Ubamatamab With First-line Chemotherapy in Ovarian Cancer 2026 | not yet recruiting | PHASE1, PHASE2 | 43 |
| NCT06197581 | Safety Assessment of Concurrent Radiotherapy and Novel Systemic Therapy for Breast Cancer 2024 | recruiting | Not applicable | 148 |
| NCT06607692 | Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed). 2024 | recruiting | PHASE1, PHASE2 | 25 |
Published literature
- Clinical trial publication Targeting homologous recombination deficiency with intensified chemotherapy versus standard chemotherapy followed by olaparib in stage III breast cancer (SUBITO): an open-label, randomised, controlled, phase 3 trialSeefat RL, Vliek SB, de Jong VMT et al. · The Lancet. Oncology · 2026 · PMID 42372741
- Clinical trial publication Patient-reported outcomes in castration-resistant prostate cancer with bone metastases treated with radium-223 with or without olaparibMcKay RR, Xie W, Ajmera A et al. · Cancer · 2026 · PMID 42319132
- Clinical trial publication Olaparib combined with abiraterone in HRR-mutated metastatic hormone-sensitive prostate cancer: a single-arm phase II trialZhang X, Wu Z, Hao L et al. · World journal of urology · 2026 · PMID 42115448
- Clinical trial publication Detection of Homologous Recombination Repair Gene Mutations by Tumor Tissue and Circulating Tumor DNA Testing in Prostate Cancer in the Phase III PROpel TrialArmstrong AJ, Saad F, Oya M et al. · JCO precision oncology · 2026 · PMID 42114035
- Clinical trial publication Efficacy of olaparib in advanced cancers with somatic or germline mutations in BAP1, BARD1, BRIP1 and PALB2Joris S, Denys H, Collignon J et al. · ESMO open · 2026 · PMID 42105598
- Cochrane review Real-World Treatment Patterns and Survival in Metastatic Castration-resistant Prostate Cancer: A Systematic Review of Observational StudiesRaval AD, Queen V, Korn MJ et al. · European urology focus · 2026 · PMID 41266184
- Randomized controlled trial Multicenter, Randomized, Phase II Trial of Olaparib Plus Radium-223 Versus Radium-223 in Men With Castration-Resistant Prostate Cancer With Bone Metastases (COMRADE)McKay RR, Xie W, Ajmera A et al. · Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026 · PMID 42096662
- Randomized controlled trial Adverse event profile following maintenance olaparib in patients with BRCA-mutated platinum-sensitive relapsed serous ovarian cancer in the phase III SOLO2 trialLedermann JA, Lortholary A, Penson RT et al. · International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2026 · PMID 41861615
- Cochrane review Circulating Tumor DNA as a Biomarker for Precision Medicine in Prostate Cancer: A Systematic ReviewChanhih N, Laraqui A, Hassine S et al. · International journal of molecular sciences · 2025 · PMID 41303533
- Cochrane review PARP Inhibitor Maintenance After First-Line Chemotherapy in Advanced-Stage Epithelial Ovarian Cancer: A Systematic Review and Meta-AnalysisPetousis S, Kahramanoglu I, Appenzeller-Herzog C et al. · JAMA network open · 2025 · PMID 41191357
- Cochrane review Impact of Olaparib, Niraparib, Rucaparib therapies on Newly Diagnosed and Relapsed Ovarian Cancer -Systematic Review and Meta-AnalysisDevi S, Chandrababu R · Asian Pacific journal of cancer prevention : APJCP · 2025 · PMID 40542754
- Cochrane review Haematological toxicity of PARP inhibitors in advanced ovarian cancer: A systematic review and meta-analysisPio Maiorano MF, Loizzi V, Maiorano BA et al. · European journal of obstetrics, gynecology, and reproductive biology · 2025 · PMID 39724774
- Meta-analysis Effectiveness and safety of PARP inhibitors in ovarian cancer: An umbrella review of systematic reviews and meta-analysesTzang CC, Huang ES, Wu HW et al. · Critical reviews in oncology/hematology · 2025 · PMID 40816592
- Meta-analysis A comprehensive comparison of PARP inhibitors as maintenance therapy in platinum-sensitive recurrent ovarian cancer: a systematic review and network meta-analysisJi S, Chen L, Yu Y et al. · Journal of ovarian research · 2025 · PMID 39885555
- Meta-analysis Efficacy and safety of PARP inhibitors in prostate cancer: An umbrella review of systematic reviews and meta-analysesTzang CC, Wu HW, Luo CA et al. · Critical reviews in oncology/hematology · 2025 · PMID 39761938
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Olaparib approved for Cancer?
Olaparib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Olaparib in clinical trials for Cancer?
ClinicalTrials.gov lists 8 registered trials linking Olaparib to Cancer: 3 are currently recruiting; 1 is active or not yet recruiting; 4 have completed. The most advanced is Phase 3 (NCT03784014). It plans or enrolled 603 participants. Registration activity spans 2015 to 2026.
What does the evidence show for Olaparib in Cancer?
Olaparib has both completed registered trials and synthesis-level publications linked to Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.