marked.bio

PARP inhibitor · small molecule

olaparib

47 active trials across 12 of our biomarkers, targeting PARP. 14 active approvals for a biomarker on marked.bio.

Also known as AZD2281, KU-0059436, Lynparza.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
olaparib
FDA, 2018
metastatic HER2-negative, deleterious germline BRCA, after chemotherapy (neoadjuvant, adjuvant or metastatic); HR+ after endocrine therapy FDA regular approval 12/01/2018; current label 1.5. Source
FDA, 2022
adjuvant, high-risk early HER2-negative, deleterious germline BRCA FDA approval 11/03/2022; current label 1.4. Source
EU (EMA), 2019
locally advanced or metastatic HER2-negative, germline BRCA1/2 II/0020, EC decision 08/04/2019. HR-positive patients must also have progressed on endocrine therapy or be unsuitable for it. Source
EU (EMA), 2022
adjuvant, high-risk early HER2-negative, germline BRCA1/2 EC decision 02/08/2022. Monotherapy or with endocrine therapy. Source
Lynparza 		BRCA1/2 mutation breast Approved 2018 Approved 2019

In the US approval report

OlympiAD vs physician's choice chemotherapy, 302 randomised (2:1)
PFS 7.0 months vs 4.2 months, HR 0.58 (0.43-0.80)

Stopped for side effects 5%

Trial details and side effects
Patients
germline BRCA-mutated HER2-negative metastatic breast cancer after chemotherapy (NCT02000622)
Most common side effects
nausea 58%, anaemia 40%, fatigue 37%, vomiting 30%, neutropenia 27% (205 patients)
Notes
Side effects from the Lynparza US label.
Source
US approval report

In the EU product information

OlympiA vs placebo, 921 vs 915 patients
IDFS 86% vs 77% free of invasive disease at 3 years, HR 0.58 (99.5% CI 0.41-0.82)OS HR 0.72 (0.56-0.93), 5-year follow-up

Trial details and side effects
Patients
adjuvant, germline BRCA-mutated high-risk early HER2-negative breast cancer (NCT02032823)
Most common side effects
nausea 57% (911 patients)
Notes
EU SmPC section 5.1 (OlympiA). Side effects from the US label.
Source
EU product information
olaparib
FDA, 2014
deleterious germline BRCA, after >=3 lines of chemotherapy AA 19/12/2014; converted to regular approval 17/08/2017 (FDA Verified clinical benefit list). No longer on the current label, so it is withdrawn; the withdrawal date (reported as 2022) was not checked against an FDA source. Source
FDA, 2017
maintenance, deleterious germline or somatic BRCA-mutated recurrent ovarian cancer in response to platinum Current label (rev. 7/2025, section 1.3) limits recurrent-ovarian maintenance to germline or somatic BRCA-mutated. Approved 2017 for all patients; year = first approval in this setting. Date the label was narrowed to BRCA not confirmed. Source
FDA, 2018
first-line maintenance, deleterious germline or somatic BRCA Label 1.1. Year confirmed: FDA approval announced 19/12/2018. Source
EU (EMA), 2019
first-line maintenance, advanced BRCA1/2-mutated (germline and/or somatic) Lynparza first EU MA 16/12/2014. II/0023, EC decision 12/06/2019. Source
Lynparza 		BRCA1/2 mutation ovarian Approved 2017 Approved 2019

In the US label

SOLO-2 vs placebo, 196 vs 99 patients
PFS 19.1 months vs 5.5 months, HR 0.30 (0.22-0.41)

Stopped for side effects 11%

Trial details and side effects
Patients
maintenance, germline BRCA-mutated recurrent ovarian cancer after response to platinum (NCT01874353)
Most common side effects
nausea 76%, fatigue 66%, anaemia 44%, vomiting 37%, diarrhoea 33% (195 patients)
Notes
Lynparza US label.
Source
US label

In the EU product information

SOLO-1 vs placebo, 260 vs 131 patients
PFS not reached vs 13.8 months, HR 0.30 (0.23-0.41)OS HR 0.55 (0.40-0.76)

Trial details and side effects
Patients
first-line maintenance, BRCA-mutated advanced ovarian cancer (NCT01844986)
Most common side effects
nausea 77%, fatigue 67%, abdominal pain 45%, vomiting 40%, anaemia 38%, diarrhoea 37% (260 patients)
Notes
EU SmPC section 5.1 (SOLO1); at 7 years 67% vs 47% of patients were alive. Side effects from the US label.
Source
EU product information
olaparib with bevacizumab
FDA, 2020
first-line maintenance, advanced ovarian cancer in response to platinum, HRD-positive (deleterious BRCA mutation and/or genomic instability) Current label 1.2. Year (reported May 2020) not checked against an FDA announcement. Year confirmed: FDA approval announced 08/05/2020. Source
EU (EMA), 2020
first-line maintenance, advanced high-grade ovarian cancer in response after platinum + bevacizumab, HRD-positive (BRCA1/2 mutation and/or genomic instability) II/0035, EC decision 03/11/2020. HRD-positive includes BRCA1/2-mutated (broad). Source
LynparzaBroader labelbevacizumab page 		BRCA1/2 mutation ovarian Approved 2020 Approved 2020

In the US label

PAOLA-1 (HRD-positive) vs placebo + bevacizumab, 255 vs 132 patients
PFS 37.2 months vs 17.7 months, HR 0.33 (0.25-0.45)

Serious side effects 31%Stopped for side effects 20%

Trial details and side effects
Patients
first-line maintenance, HRD-positive advanced ovarian cancer, with bevacizumab (NCT02477644)
Most common side effects
fatigue 53%, nausea 53%, anaemia 41%, lymphopenia 24%, vomiting 22% (535 patients)
Notes
HRD-positive includes BRCA mutation. Lynparza US label.
Source
US label

In the EU product information

PAOLA-1 (HRD-positive) vs placebo + bevacizumab, 255 vs 132 patients
PFS 37.2 months vs 17.7 months, HR 0.33 (0.25-0.45)OS HR 0.62 (0.45-0.85)

Trial details and side effects
Patients
first-line maintenance, HRD-positive advanced ovarian cancer, with bevacizumab (NCT02477644)
Most common side effects
fatigue 53%, nausea 53%, anaemia 41%, lymphopenia 24%, vomiting 22% (535 patients)
Notes
EU SmPC section 5.1 (PAOLA-1 HRD-positive subgroup). Side effects from the US label.
Source
EU product information
olaparib
FDA, 2019
maintenance after >=16 weeks of first-line platinum, deleterious germline BRCA FDA approval 27/12/2019; current label 1.6. Source
EU (EMA), 2020
maintenance after >=16 weeks of first-line platinum, germline BRCA1/2 II/0033, EC decision 03/07/2020. Source
Lynparza 		BRCA1/2 mutation pancreatic Approved 2019 Approved 2020

POLO vs placebo, 154 randomised (3:2)
PFS 7.4 months vs 3.8 months, HR 0.53 (0.35-0.81)Response 23% vs 12%OS 18.9 months vs 18.1 months, HR 0.91 (0.56-1.46), not significant

Stopped for side effects 6%

Trial details and side effects
Patients
maintenance, germline BRCA-mutated metastatic pancreatic cancer after first-line platinum (NCT02184195)
Most common side effects
fatigue 60%, nausea 45%, abdominal pain 34%, diarrhoea 29%, constipation 23% (91 patients)
Notes
Side effects from the Lynparza US label.
Source
US approval report
olaparib
FDA, 2020
mCRPC with deleterious germline or somatic HRR gene mutation, after enzalutamide or abiraterone Label 1.7: HRR gene-mutated (includes BRCA1/2). Year confirmed: FDA approval announced 19/05/2020. Source
EU (EMA), 2020
mCRPC, BRCA1/2 (germline and/or somatic), after a new hormonal agent II/0036, EC decision 03/11/2020. Source
Lynparza 		BRCA1/2 mutation prostate Approved 2020 Approved 2020

PROfound (cohort A) vs enzalutamide or abiraterone, 245 (BRCA1/2 or ATM)
rPFS 7.4 months vs 3.6 months, HR 0.34 (0.25-0.47)Response 33% vs 2%OS 19.1 months vs 14.7 months, HR 0.69 (0.50-0.97)

Serious side effects 36%Stopped for side effects 18%

Trial details and side effects
Patients
HRR gene-mutated mCRPC after enzalutamide or abiraterone (NCT02987543)
Most common side effects
anaemia 46%, nausea 41%, fatigue 41%, decreased appetite 30%, diarrhoea 21% (256 patients)
Notes
Radiographic progression-free survival. Cohort A covers BRCA1, BRCA2 or ATM. Side effects from the Lynparza US label.
Source
US approval report
olaparib with abiraterone + prednisone
FDA, 2023
mCRPC, deleterious BRCA mutation FDA approval 31/05/2023; current label 1.8. The EU combination is not BRCA-restricted. Source
Lynparzaabiraterone page 		BRCA1/2 mutation prostate Approved 2023 Not approved

PROpel (BRCA-mutated subgroup) vs placebo + abiraterone, 85 (BRCA-mutated)
rPFS not reached vs 8 months, HR 0.24 (0.12-0.45)OS HR 0.30 (0.15-0.59)

Serious side effects 39%Stopped for side effects 16%

Trial details and side effects
Patients
BRCA-mutated mCRPC (NCT03732820)
Most common side effects
anaemia 48%, fatigue 38%, nausea 30%, diarrhoea 19% (398 (all patients) patients)
Notes
Olaparib with abiraterone and prednisone. The approval is limited to BRCA-mutated patients. Side effects from the Lynparza US label (all patients).
Source
US approval report

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
BRCA1/2 mutation 37 73 Phase 4
IDH1/2 mutation 5 6 Phase 2
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 2 2 Phase 1/2
MSI-H / dMMR 2 4 Phase 3
FGFR2 fusion or rearrangement 1 1 Phase 1
FGFR3 alteration (mutation or fusion) 1 1 Phase 1
HER2 (ERBB2) activating mutation 1 1 Phase 2
KRAS G12C 1 2 Phase 2
KRAS G12D 1 1 Phase 2
PIK3CA activating mutation 1 1 Phase 1
BRAF V600E 0 1 –
EGFR exon 19 deletion / L858R 0 2 –

Sponsors

Industry sponsors leading active biomarker-selected trials of olaparib.

  1. AstraZeneca 7
  2. Artios Pharma 1
  3. AGO Research 1
  4. MSD (Merck & Co.) 1
  5. Daewoong Pharmaceutical 1
  6. Hangzhou SynRx Therapeutics Biomedical Technology 1
  7. Boryung Pharmaceutical 1
  8. Exelixis 1

Trials

47 of 90 trials shown

  1. Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations

    Active, not recruiting Phase 4 AstraZeneca Started 2022Primary completion 2024-10 NCT05457257

    olaparib FDA EUenzalutamide FDAabiraterone FDA EUprednisone

    Deleterious or suspected deleterious BRCA1/2 mutation in tumor tissue.

    BRCA1/2 mutationMetastatic Castration-resistant Prostate Cancer

  2. Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer

    Recruiting Phase 3 NRG Oncology Started 2025Primary completion 2034-12 NCT06580314

    bevacizumab FDA EUolaparib FDA EU

    Other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic), (excluding tumors that are known mismatch repair defici…

    BRCA1/2 mutationMSI-H / dMMRFallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, Fallopian Tube Malignant Mixed Mesodermal (Mullerian) Tumor, FIGO Stage III Ovarian Cancer 2014

  3. Platinum and Polyadenosine 5'Diphosphoribose Polymerisation Inhibitor for Neoadjuvant Treatment of Triple Negative Breast Cancer and/or Germline BRCA Positive Breast Cancer

    Recruiting Phase 2/3 Cambridge University Hospitals NHS Foundation Trust Started 2016Primary completion 2024-06 NCT03150576

    olaparib FDA EUpaclitaxelcarboplatin

    Germline BRCA (gBRCA) mutation positive, HER2 negative, and PgR / ER of any status.

    BRCA1/2 mutationStatus may be outdated, last updated 2022-11-14Breast Cancer

  4. Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

    Active, not recruiting Phase 3 AstraZeneca Started 2014Primary completion 2020-03 NCT02032823

    olaparib FDA EU

    Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicte…

    BRCA1/2 mutationBreast Cancer

  5. Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

    Active, not recruiting Phase 3 AstraZeneca Started 2013Primary completion 2016-09 NCT01874353

    olaparib FDA EU

    Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicte…

    BRCA1/2 mutationPlatinum Sensitive, BRCA Mutated, Relapsed Ovarian Cancer, Following Complete or Partial Response to Platinum Based Chemotherapy

  6. Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

    Active, not recruiting Phase 3 AstraZeneca Started 2013Primary completion 2018-05 NCT01844986

    olaparib FDA EU

    … with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer an…

    BRCA1/2 mutationNewly Diagnosed, Advanced Ovarian Cancer, FIGO Stage III-IV, BRCA Mutation

  7. Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer

    Recruiting Phase 2 Cambridge University Hospitals NHS Foundation Trust Started 2025Primary completion 2027-07 NCT05093231

    pembrolizumab FDA EUolaparib

    Confirmation that the PDA has TMB \>4 mutations/Mb, or dMMR gene mutation, or MSI-H by IHC.

    MSI-H / dMMRPancreatic Cancer

  8. Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer

    Recruiting Phase 2 Okayama University Started 2024Primary completion 2028-06 NCT05485766

    pembrolizumabpaclitaxelcarboplatinolaparib FDA EU

    Confirmed germline BRCA 1/2 mutated.

    BRCA1/2 mutationTriple Negative Breast Neoplasms, Triple Negative Breast Cancer, Breast Neoplasms, Breast Cancer

  9. Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer

    Recruiting Phase 2 GBG Forschungs Started 2024Primary completion 2028-12 NCT06201234

    olaparib FDA EUelacestrant

    …e Receptor (HR)-Positive, HER2-negative Locally Advanced or Metastatic Breast Cancer With gBRCA1/2 Mutations

    BRCA1/2 mutationHormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer, BRCA1 Mutation, BRCA2 Mutation

  10. Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd

    Recruiting Phase 1/2 Gustave Roussy, Cancer Campus, Grand Paris Started 2024Primary completion 2027-09 NCT06298084

    patritumab deruxtecanolaparib

    Patients with HER2-low tumors must have been treated with taxanes.

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Cancer Metastatic, HER2-positive Metastatic Breast Cancer, HER2 Low Breast Carcinoma, Advanced Breast Cancer

  11. Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2023Primary completion 2026-09 NCT05554328

    olaparibselumetinib

    …hway mutant ovarian, primary peritoneal, or fallopian tube ("ovarian") cancer (activating mutations in KRAS, NRAS, HRAS, BRAF, MEK1, MEK2, or inactivating mutations in NF1)

    KRAS G12CKRAS G12DRecurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma

  12. Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE)

    Recruiting Phase 2 German Cancer Research Center Started 2023Primary completion 2030-03 NCT05332561

    atezolizumabinavolisibipatasertibolaparibsacituzumab govitecantrastuzumabpertuzumab

    Arm 6 (Trastuzumab / Pertuzumab, ERBBB): HER2 exon-20 insertion, Activating HER2-mutation

    HER2 (ERBB2) activating mutationBRCA1/2 mutationEarly-stage Breast Cancer

  13. Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)

    Recruiting Phase 1/2 Artios Pharma Started 2023Primary completion 2028-06 NCT05898399

    ART6043olaparib FDA EU

    Documentation of a deleterious or suspected deleterious gBRCA mutation.

    BRCA1/2 mutationAdvanced Solid Tumor, Metastatic Solid Tumor

  14. Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With Select HRR Gene Alterations

    Active, not recruiting Phase 2 Rana McKay, MD Started 2023Primary completion 2026-08 NCT05498272

    olaparib FDA EULHRH agonist

    Must have evidence of germline or somatic BRCA1/2, PALB2, RAD51B, RAD51C, RAD51D, RAD54L2, BARD1, FANCA, BRIP1, CHEK2, ATM, and CDK12 ge…

    BRCA1/2 mutationProstate Cancer, BRCA1 Mutation, BRCA2 Mutation, Prostatic Adenocarcinoma

  15. Evaluating the Efficacy and Safety of Fulvestrant Plus DNA Damage Repair Inhibitors After a CDK4/6 Inhibitor

    Recruiting Phase 2 Seoul National University Hospital Started 2022Primary completion 2025-12 NCT05536128

    olaparib FDA EUfulvestrant

    13. \<For cohort A\> Patients with known germline or somatic mutations of BRCA1 or BRCA2

    BRCA1/2 mutationAdvanced Breast Cancer

  16. WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC

    Recruiting Phase 2 AGO Research Started 2022Primary completion 2028-01 NCT04644289

    olaparib FDA EUdurvalumab

    … epithelial ovarian, fallopian tube or primary peritoneal cancer or known (BReast CAncer) BRCA mutation and any histologic type

    BRCA1/2 mutationEpithelial Ovarian Cancer

  17. Study of Stereotactic Radiosurgery With Olaparib Followed by Durvalumab and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases

    Active, not recruiting Phase 1/2 Colette Shen Started 2022Primary completion 2026-07 NCT04711824

    olaparib FDA EUdurvalumabpaclitaxelnab-paclitaxeleribulincarboplatincisplatincapecitabinegemcitabine

    or 2) HER2-negative (with ER/PR expression \>=10% with germline or somatic BRCA mutation.

    BRCA1/2 mutationBreast Cancer, Brain Metastases, Adult

  18. A Study of Olaparib and Pembrolizumab in People With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer

    Active, not recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2022Primary completion 2025-05 NCT05203445

    olaparib FDA EUpembrolizumab

    All patients must have a germline mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.

    BRCA1/2 mutationBreast Cancer

  19. Pembrolizumab, Olaparib, and Temozolomide for People With Glioma

    Recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2022Primary completion 2027-01 NCT05188508

    pembrolizumabolaparibtemozolomide

    Histologically confirmed grade II or III IDH-mutated glioma (absence of known CDKN2A/B deletion) that has recurred after first line therapy (c…

    IDH1/2 mutationGlioma

  20. APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation

    Recruiting Phase 2 National Cancer Institute (NCI) Started 2021Primary completion 2027-10 NCT04858334

    olaparib FDA EU

    Patient must have a known pathogenic or likely pathogenic germline or somatic mutation in BRCA1, BRCA2, or PALB2, as determined by a Clinical Laboratory Improvement Amendments (CLIA) c…

    BRCA1/2 mutationPancreatic Acinar Cell Carcinoma, Pancreatic Adenosquamous Carcinoma, Pancreatic Squamous Cell Carcinoma, Resectable Pancreatic Acinar Cell Carcinoma

  21. Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2021Primary completion 2025-07 NCT04548752

    olaparib FDA EUpembrolizumab

    Patients must have one of the following mutations: germline mutation in BRCA 1 or 2 that was tested in a Clinical Laboratory Improvement Act (CLIA) certified lab defi…

    BRCA1/2 mutationMetastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8

  22. Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer

    Recruiting Phase 2 M.D. Anderson Cancer Center Started 2020Primary completion 2027-12 NCT04090567

    Cediranibceralasertibolaparib FDA EU

    Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer

    BRCA1/2 mutationAdvanced Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8

  23. Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2020Primary completion 2025-03 NCT03878095

    ceralasertibolaparib

    Patients must have biopsy-confirmed evidence of an IDH1 or IDH2 mutation, confirmed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, associat…

    IDH1/2 mutationMalignant Solid Neoplasm, Refractory Cholangiocarcinoma, Refractory Malignant Solid Neoplasm

  24. Using the Anticancer Drug Olaparib to Treat Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome With an Isocitrate Dehydrogenase (IDH) Mutation

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2020Primary completion 2024-01 NCT03953898

    olaparib

    Patients must have a documented IDH1 or IDH2 mutation within 30 days of inclusion based on mutational testing.

    IDH1/2 mutationAcute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia Post Cytotoxic Therapy, Recurrent Acute Myeloid Leukemia

  25. Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients.

    Active, not recruiting Phase 2 UNICANCER Started 2019Primary completion 2023-11 NCT04053322

    durvalumabolaparib FDA EUfulvestrant

    Documented personal germline alteration in BRCA1 or BRCA2 that is predicted to be deleterious.

    BRCA1/2 mutationER-positive and HER2-negative Metastatic or Locally Advanced Breast Cancer, a Germline or Somatic BRCA Mutation, or a Deleterious Alteration of Other Genes Involved in Homologous Recombination Repair (HRR) or in MSI Status

  26. Carboplatin or Olaparib for BRcA Deficient Prostate Cancer

    Recruiting Phase 2 VA Office of Research and Development Started 2019Primary completion 2027-08 NCT04038502

    carboplatinolaparib FDA EU

    Carboplatin or Olaparib for BRcA Deficient Prostate Cancer

    BRCA1/2 mutationMetastatic Castrate Resistant Prostate Cancer, BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D, or RAD54L Mutations

  27. Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors

    Active, not recruiting Phase 2 University Health Network, Toronto Started 2019Primary completion 2026-09 NCT03991832

    olaparibdurvalumab

    …ic and oligodendroglial tumors by World Health Organization 2016 classification which are IDH mutant.

    IDH1/2 mutationGlioma, Cholangiocarcinoma, Solid Tumor, IDH Mutation

  28. Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2019Primary completion 2025-04 NCT03212274

    olaparib

    …, or for which no effective standard therapy exists, with biopsy-confirmed evidence of an IDH1 or IDH2 mutation associated with neomorphic activity of the encoded proteins

    IDH1/2 mutationAdvanced Malignant Solid Neoplasm, Glioblastoma, Recurrent Cholangiocarcinoma, Recurrent Glioma

  29. Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002)

    Active, not recruiting Phase 2 MSD (Merck & Co.) Started 2018Primary completion 2025-08 NCT03742895

    olaparib FDA EU

    For participants who have somatic BRCAm breast cancer:

    BRCA1/2 mutationAdvanced Solid Neoplasms

  30. Adavosertib With or Without Olaparib in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

    Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2018Primary completion 2026-12 NCT03579316

    adavosertibolaparib FDA EUceralasertib

    Are germline or somatic BRCA mutant or HRD positive by a licensed test prior to enrollment.

    BRCA1/2 mutationRecurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma

  31. Olaparib In Metastatic Breast Cancer

    Active, not recruiting Phase 2 Beth Israel Deaconess Medical Center Started 2018Primary completion 2025-07 NCT03344965

    olaparib FDA EU

    Cohort 2a: somatic mutation of BRCA 1 or BRCA 2

    BRCA1/2 mutationMetastatic Breast Cancer, Invasive Breast Cancer, Somatic Mutation Breast Cancer (BRCA1), Somatic Mutation Breast Cancer (BRCA2)

  32. Testing Olaparib Either Alone or in Combination With Atezolizumab in BRCA Mutant Non-HER2-positive Breast Cancer

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2017Primary completion 2026-06 NCT02849496

    atezolizumabolaparib FDA EU

    …d unresectable locally advanced or metastatic non-HER2-positive breast cancer and a known BRCA 1/2 mutation present

    BRCA1/2 mutationAnatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Unresectable Breast Carcinoma, Metastatic Breast Carcinoma

  33. PARP-inhibition and CTLA-4 Blockade in BRCA-deficient Ovarian Cancer

    Active, not recruiting Phase 1/2 New Mexico Cancer Research Alliance Started 2016Primary completion 2020-12 NCT02571725

    olaparib FDA EUtremelimumab

    Patients must have a confirmed germline mutation in the BRCA1 or BRCA2 gene

    BRCA1/2 mutationOvarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

  34. A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.

    Active, not recruiting Phase 1/2 AstraZeneca Started 2016Primary completion 2021-09 NCT02734004

    olaparib FDA EUdurvalumabbevacizumab FDA EU

    gBRCAm HER2-negative metastatic breast cancer (module 2)

    BRCA1/2 mutationOvarian, Breast, SCLC, Gastric Cancers

  35. Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer

    Recruiting Phase 1 Daewoong Pharmaceutical Started 2026Primary completion 2027-03 NCT07371104

    olaparib FDA EU

    Patients with advanced high-grade ovarian cancer harboring a BRCA mutation. 3.

    BRCA1/2 mutationCancer, Ovarian Cancer

  36. Study of SYN818 With Olaparib for the Treatment of Locally Advanced or Metastatic Solid Tumors

    Recruiting Phase 1 Hangzhou SynRx Therapeutics Biomedical Technology Started 2025Primary completion 2028-08 NCT07156253

    olaparib FDA EU

    …tic solid tumor and has exhausted all standard-of-care treatment options, with documented BRCA mutations and/or homologous recombination repair deficiency (Part 1).

    BRCA1/2 mutationMetastatic Solid Tumor, Ovarian Cancer, Breast Cancer, BRCA 1 /2 and / or HRD

  37. A Bioequivalence Study to Evaluate Pharmacokinetics and Safety of BR2022 and BR2022-1 in Patients With Deleterious or Suspected Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer

    Recruiting Phase 1 Boryung Pharmaceutical Started 2025Primary completion 2026-05 NCT07069335

    olaparib FDA EU

    Patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been t…

    BRCA1/2 mutationOvarian Cancer

  38. Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer

    Recruiting Phase 1 Dana-Farber Cancer Institute Started 2024Primary completion 2027-05 NCT06488378

    Axatilimabolaparib FDA EU

    Documented germline or somatic mutation in BRCA1, BRCA2, or germline mutation in PALB2 that is predicted to be deleterious or suspected d…

    BRCA1/2 mutationHER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Cancer, PALB2-Mutated Breast Carcinoma, HER2-negative Breast Cancer, BRCA1 Mutation

  39. A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors

    Recruiting Phase 1 Exelixis Started 2024Primary completion 2029-01 NCT05932862

    XL309olaparib FDA EU

    …R2)-negative breast cancer, with deleterious or suspected deleterious breast cancer gene (BRCA)1/2 alteration.

    BRCA1/2 mutationAdvanced Solid Tumor

  40. Combination of Olaparib and Navitoclax in Women with HGSC and TNBC

    Active, not recruiting Phase 1 Sunnybrook Health Sciences Centre Started 2022Primary completion 2025-03 NCT05358639

    olaparib FDA EUnavitoclax

    Metastatic TNBC: tumors that are known to have deleterious somatic or germline mutations in BRCA1, BRCA2, or PALB2.

    BRCA1/2 mutationHigh Grade Serous Carcinoma, Triple Negative Breast Cancer, Ovarian Cancer

  41. Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer

    Recruiting Phase 1 National Cancer Institute (NCI) Started 2021Primary completion 2026-11 NCT04633239

    abemaciclibolaparib FDA EU

    …ade serous histology is required (for the dose expansion cohort only) (data on BRCA (e.g. germline BRCA, Somatic BRCA, Neither, Unknown) and homologous recombination deficiency (HRD)/Loss of He…

    BRCA1/2 mutationRecurrent Ovarian High Grade Serous Adenocarcinoma, Recurrent Platinum-Resistant Ovarian Carcinoma

  42. Testing the Sequential Combination of the Anti-cancer Drugs Olaparib Followed by Adavosertib (AZD1775) in Patients With Advanced Solid Tumors With Selected Mutations and PARP Resistance, STAR Study

    Active, not recruiting Phase 1 National Cancer Institute (NCI) Started 2020Primary completion 2023-02 NCT04197713

    adavosertibolaparib FDA EU

    Germline or somatic mutations in BRCA1 or BRCA2

    BRCA1/2 mutationAdvanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm

  43. Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations

    Active, not recruiting Phase 1 National Cancer Institute (NCI) Started 2019Primary completion 2024-07 NCT03842228

    copanlisibdurvalumabolaparib

    or actionable mutations in the PTEN gene, or hotspot mutations in the PIK3CA gene (E542, E545 or H1047 are accepted).

    PIK3CA activating mutationAdvanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm

  44. Olaparib + Sapacitabine in BRCA Mutant Breast Cancer

    Active, not recruiting Phase 1 Dana-Farber Cancer Institute Started 2018Primary completion 2022-04 NCT03641755

    Sapacitabineolaparib FDA EU

    Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicte…

    BRCA1/2 mutationBreast Cancer

  45. Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer

    Active, not recruiting Phase 1 AstraZeneca Started 2016Primary completion 2020-03 NCT02546661

    fexagratinibdurvalumabolaparibadavosertibVistusertibAZD9150selumetinib

    Confirmation of FGFR3 mutation or FGFR fusion

    FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementMuscle Invasive Bladder Cancer

  46. Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents

    Active, not recruiting Phase 1 AstraZeneca Started 2014Primary completion 2025-03 NCT02264678

    ceralasertibolaparib FDA EUdurvalumabsaruparibcarboplatin

    Module 5 Part B: known or suspected BRCA mutation, PALB2 mutation, RAD51C/D mutation or HRD positive status

    BRCA1/2 mutationAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer

  47. Olaparib in Treating Patients With Newly Diagnosed BRCA-Mutant Ovarian, Primary Peritoneal, or Fallopian Cancer Before Surgery

    Active, not recruiting Early Phase 1 M.D. Anderson Cancer Center Started 2019Primary completion 2027-06 NCT03943173

    Chemotherapyolaparib FDA EU

    Olaparib in Treating Patients With Newly Diagnosed BRCA-Mutant Ovarian, Primary Peritoneal, or Fallopian Cancer Before Surgery

    BRCA1/2 mutationBRCA-Mutated Ovarian Carcinoma, BRCA1 Gene Mutation, BRCA2 Gene Mutation, High Grade Fallopian Tube Serous Adenocarcinoma