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Clinical trials for olaparib

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    137 result(s) found for: olaparib. Displaying page 1 of 7.
    1  2  3  4  5  6  7  Next»
    EudraCT Number: 2013-003839-30 Sponsor Protocol Number: D081CC00006 Start Date*: 2014-06-16
    Sponsor Name:AstraZeneca AB
    Full Title: A randomised, double-blind, parallel group, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germl...
    Medical condition: Adjuvant breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Trial now transitioned) HU (Trial now transitioned) IT (Trial now transitioned) BE (Trial now transitioned) SE (Trial now transitioned) ES (Ongoing) NL (Ongoing) AT (Trial now transitioned) IS (Trial now transitioned) PL (Trial now transitioned) PT (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-004032-28 Sponsor Protocol Number: 112415 Start Date*: 2021-11-24
    Sponsor Name:Radboud University Medical Center
    Full Title: Pharmacokinetic boosting of olaparib to improve exposure, tolerance and cost-effectiveness (PROACTIVE-study)
    Medical condition: Ovarian cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-005838-22 Sponsor Protocol Number: CLIO Start Date*: 2016-07-22
    Sponsor Name:UZLeuven
    Full Title: Circulating tumor DNA guiding (Olaparib) Lynparza® treatment in Ovarian Cancer (CLIO). Establishing the value of a ctDNA-based HRD assay for predicting olaparib response in women with relapsed ovar...
    Medical condition: platinum-sensitive and platinum-resistant relapsed ovarian cancer
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2013-003520-37 Sponsor Protocol Number: D081DC00008 Start Date*: 2014-02-04
    Sponsor Name:AstraZeneca AB
    Full Title: A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatmen...
    Medical condition: metastatic castrate-resistant prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) NL (Completed) CZ (Completed) ES (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-002361-22 Sponsor Protocol Number: D5336C00001 Start Date*: 2017-12-05
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination with Olaparib versus Olaparib Monotherapy in the Treatm...
    Medical condition: Triple negative Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075566 Triple negative breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) CZ (Completed) ES (Ongoing) PL (Trial now transitioned) BE (Completed) FR (Completed) IE (Completed) NL (Completed) PT (Trial now transitioned) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002808-28 Sponsor Protocol Number: OZM-061 Start Date*: 2017-12-29
    Sponsor Name:Princess Margaret Cancer Centre
    Full Title: Olala Trial: A Retrospective/Prospective Analysis of Characterization of the Long-Term Responders on Olaparib in Solid Tumours
    Medical condition: epithelial ovarian cancer (including fallopian tube or peritoneal cancer)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061328 Ovarian epithelial cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-001216-19 Sponsor Protocol Number: Start Date*: 2014-11-13
    Sponsor Name:NHS Greater Glasgow & Clyde [...]
    1. NHS Greater Glasgow & Clyde
    2. University of Glasgow
    Full Title: Short-course radiotherapy plus olaparib for newly diagnosed glioblastoma in patients unsuitable for radical chemoradiation: a randomised phase II clinical trial preceded by a lead-in phase I dose e...
    Medical condition: glioblastoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2014-005095-28 Sponsor Protocol Number: IRST186.02 Start Date*: 2015-04-16
    Sponsor Name:ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
    Full Title: Olaparib as salvage treatment for cisplatin-resistant germ cell tumor.
    Medical condition: cisplatin-resistant germ cell tumor
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061184 Germ cell cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004682-40 Sponsor Protocol Number: CBYL719K12301 Start Date*: 2021-06-16
    Sponsor Name:Novartis Pharma AG
    Full Title: EPIK-O: A Phase III, multi-center, randomized (1:1), open-label, active-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with olaparib as compared to single a...
    Medical condition: Platinum-resistant or refractory, high-grade serous ovarian cancer with no germline BRCA mutation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033130 Ovarian cancer NOS LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed) PT (Completed) FI (Trial now transitioned) CZ (Completed) DK (Completed) SK (Completed) FR (Completed) NL (Completed) ES (Ongoing) DE (Trial now transitioned) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-003007-19 Sponsor Protocol Number: MK-7339-002 Start Date*: 2018-11-29
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase 2 Study of Olaparib Monotherapy in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer
    Medical condition: Homologous recombination repair mutation (HRRm) or Homologous recombination deficiency (HRD) positive cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) IE (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) GB (GB - no longer in EU/EEA) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-004384-39 Sponsor Protocol Number: ABCSG-45 Start Date*: 2018-12-18
    Sponsor Name:Austrian Breast & Colorectal Cancer Study Group (ABCSG)
    Full Title: A prospective, open, randomized, phase II study of carboplatin/olaparib in the pre-operative treatment of patients with triple-negative primary breast cancer which exhibit the features of positive ...
    Medical condition: Early invasive triple negative breast cancer with positive HRD status (acc. to Myriad mychoice© test)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075566 Triple negative breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-003355-38 Sponsor Protocol Number: D0816C00025 Start Date*: 2019-12-05
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase I, Open-label, Parallel Group Study to Investigate Olaparib Safety and Tolerability, Efficacy and Pharmacokinetics in Paediatric Patients with Solid Tumours
    Medical condition: Solid Tumours
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) ES (Ongoing) DK (Trial now transitioned) HU (Trial now transitioned) IT (Trial now transitioned) AT (Prematurely Ended) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004556-27 Sponsor Protocol Number: D933IC00003 Start Date*: 2018-04-29
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Cisplatin-In...
    Medical condition: Unresectable Stage IV Urothelial Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10022880 Invasive bladder cancer stage IV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-005231-22 Sponsor Protocol Number: D931CC00001 Start Date*: 2022-09-02
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase II, Multicentre, Open-Label Study to Assess the Efficacy and Safety of Olaparib Monotherapy and Olaparib Plus Durvalumab Combination as Neoadjuvant Therapy in Patients with BRCA Mutations a...
    Medical condition: BRCA Mutations and Early Stage HER2-Negative Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Restarted) DE (Ongoing) AT (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-001054-34 Sponsor Protocol Number: D0816C00018 Start Date*: 2018-01-11
    Sponsor Name:AstraZeneca AB
    Full Title: LUCY - Lynparza Breast Cancer Real-World Utility, Clinical Effectiveness and Safety Study A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-...
    Medical condition: Metastatic Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) HU (Completed) FR (Completed) PL (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-001589-85 Sponsor Protocol Number: D081FC00001 Start Date*: 2014-11-03
    Sponsor Name:Astrazeneca AB
    Full Title: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Pr...
    Medical condition: Patients with gBRCA mutated metastatic pancreatic cancer whose disease has not progressed on first line platinum based chemotherapy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) BE (Completed) NL (Completed) ES (Ongoing) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-005137-20 Sponsor Protocol Number: D0819C00003 Start Date*: 2014-04-14
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to assess the efficacy and safety of Olaparib Monotherapy versus Physician’s Choice Chemotherapy in the Treatment of Metastatic B...
    Medical condition: Metastatic Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Completed) IT (Completed) CZ (Completed) ES (Ongoing) BG (Completed) PL (Completed) RO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-001398-22 Sponsor Protocol Number: SOLTI-1910 Start Date*: 2021-12-28
    Sponsor Name:SOLTI
    Full Title: Predicting olaparib sensitivity in patients with unresectable locally advanced/metastatic HER2-negative breast cancer with BRCA1, BRCA2, PALB2, RAD51C or RAD51D mutations or RAD51-foci low test: RA...
    Medical condition: Pre and post-menopausal women and men with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) or ET ±CDK4/6-resistant hormonal receptor positive and HER2-negative (HR+...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003883-36 Sponsor Protocol Number: CFTSp104 Start Date*: 2017-02-01
    Sponsor Name:The Christie NHS Foundation Trust
    Full Title: Single arm feasibility of multi-maintenance olaparib after disease recurrence in participants with platinum sensitive BRCAm high grade serous ovarian cancer
    Medical condition: platinum sensitive BRCAm high grade serous ovarian cancer
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    Population Age: Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2016-000559-28 Sponsor Protocol Number: OCTO-062 Start Date*: 2017-01-25
    Sponsor Name:University of Oxford
    Full Title: Randomised phase II Trial of olaparib, chemotherapy or olaparib and cediranib in patients with platinum–resistant ovarian cancer
    Medical condition: BRCA mutated platinum-resistant ovarian cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10033131 Ovarian carcinoma LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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