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Clinical trials for Niraparib

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    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).

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    48 result(s) found for: Niraparib. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2017-003552-23 Sponsor Protocol Number: 64091742PCR2002 Start Date*: 2018-05-10
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
    Medical condition: Metastatic castration-resistant prostate cancer (mCRPC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10076506 Castration-resistant prostate cancer LLT
    21.1 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) ES (Ongoing) BE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000825-18 Sponsor Protocol Number: CSET2020/3047 Start Date*: 2020-05-12
    Sponsor Name:Gustave Roussy
    Full Title: An open-label, multicentric, phase Ib/II study to assess the safety and efficacy of AsiDNATM, a DNA repair inhibitor, administered intravenously in addition to Niraparib in patients with relapsed p...
    Medical condition: Relapsed platinum sensitive ovarian cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066697 Ovarian cancer recurrent PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-002359-39 Sponsor Protocol Number: 213406 Start Date*: 2020-09-18
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A PHASE 1, MULTICENTRE, OPEN-LABEL, DOSE-ESCALATION AND COHORT EXPANSION STUDY OF NIRAPARIB AND DOSTARLIMAB IN PAEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMOURS
    Medical condition: Recurrent or refractory solid tumour
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065147 Malignant solid tumor LLT
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) GB (GB - no longer in EU/EEA) FR (Trial now transitioned) DE (Trial now transitioned) HU (Trial now transitioned) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004269-26 Sponsor Protocol Number: ENGOT-ov24-NSGO Start Date*: 2015-05-22
    Sponsor Name:Nordic Society of Gynaecological Oncology - Clinical Trial Unit
    Full Title: Niraparib versus niraparib-bevacizumab combination in Women with platinum-sensitive epithelial ovarian, fallopian tube, or peritoneal cancer. Part 1: AVANOVA1 - A phase I study to evaluate the saf...
    Medical condition: Women with relapsed platinum-sensitive epithelial ovarian 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
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061344 Peritoneal neoplasm PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10016180 Fallopian tube cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DK (Completed) SE (Completed) NO (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2023-000183-65 Sponsor Protocol Number: TTCC-2022-01-RADIAN Start Date*: 2023-08-23
    Sponsor Name:Grupo Español de Tratamiento de Tumores de Cabeza y Cuello (TTCC)
    Full Title: Phase Ib/II non-randomized non-comparative two-cohort study of Niraparib and Dostarlimab plus (Chemo)RadIotherapy in Locally-Advanced head and Neck squamous cell carcinoma (RADIAN)
    Medical condition: Locally-Advanced head and Neck squamous cell carcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060121 Squamous cell carcinoma of head and neck PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003364-12 Sponsor Protocol Number: 64091742PCR3001 Start Date*: 2019-04-17
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects ...
    Medical condition: Metastatic Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 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) DE (Trial now transitioned) FR (Trial now transitioned) NL (Completed) CZ (Trial now transitioned) HU (Trial now transitioned) PL (Trial now transitioned) PT (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004367-12 Sponsor Protocol Number: FCR173009 Start Date*: 2019-10-02
    Sponsor Name:Fundación CRIS de investigación para vencer el cáncer
    Full Title: A phase I-II study to evaluate the efficacy and safety of niraparib in combination with cabozantinib (XL184) in patients with advanced urothelial cancer after failure to first-line platinum-based c...
    Medical condition: Urinary tract or renal cell carcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077840 Urothelial cancer of renal pelvis LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10038389 Renal cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2019-001226-10 Sponsor Protocol Number: 1.0 Start Date*: 2020-09-29
    Sponsor Name:FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    Full Title: PHASE II PROSPECTIVE STUDY OF NIRAPARIB IN THE SALVAGE TREATMENT OF PATIENTS WITH METASTATIC/RECURRENT/PERSISTENT UTERINE CERVICAL CARCINOMA: PROOF OF CONCEPT (Translational substudy: Evaluation ...
    Medical condition: METASTATIC/RECURRENT/PERSISTENT UTERINE CERVICAL CARCINOMA
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10046769 Uterine carcinoma LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-001852-23 Sponsor Protocol Number: M14ABC Start Date*: 2017-09-29
    Sponsor Name:NKI-AVL
    Full Title: A feasibility study of niraparib for advanced, BRCA1-like, HER2-negative breast cancer patients
    Medical condition: Breast cancer, advanced
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-002202-20 Sponsor Protocol Number: 213400 Start Date*: 2020-12-07
    Sponsor Name:GlaxoSmithKline Research & Development Ltd.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Dise...
    Medical condition: Non-small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Trial now transitioned) NL (Trial now transitioned) DE (Trial now transitioned) NO (Trial now transitioned) BE (Trial now transitioned) GR (Trial now transitioned) HU (Trial now transitioned) BG (Trial now transitioned) IT (Trial now transitioned) PL (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-003042-20 Sponsor Protocol Number: ET21-169 Start Date*: 2022-06-21
    Sponsor Name:Centre Léon Bérard
    Full Title: PARPi-PANC - A multicentric, single arm, phase II trial assessing the efficacy of niraparib as first line therapy for patients with metastatic homologous repair-deficient pancreatic cancer
    Medical condition: Patients with metastatic homologous repair-deficient pancreatic cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-000413-20 Sponsor Protocol Number: 3000-03-005/ENGOT-OV44/GSK213350 Start Date*: 2018-11-07
    Sponsor Name:TESARO, Inc.
    Full Title: A Randomized, Double-Blind, Phase 3 Comparison of Platinum-Based Therapy with TSR-042 and Niraparib Versus Standard of Care Platinum-Based Therapy as First-line Treatment of Stage III or IV Non-muc...
    Medical condition: Stage 3 or 4 High Grade Non-mucinous epithelial ovarian cancer (serous, endometrial, clear cell, carcinosarcoma, and mixed pathologies)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070907 Ovarian cancer stage III PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070908 Ovarian cancer stage IV PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FI (Trial now transitioned) BE (Trial now transitioned) GB (GB - no longer in EU/EEA) DK (Trial now transitioned) CZ (Trial now transitioned) FR (Trial now transitioned) GR (Trial now transitioned) PL (Trial now transitioned) NL (Ongoing) ES (Ongoing) NO (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002209-25 Sponsor Protocol Number: 67652000PCR3002 Start Date*: 2020-10-12
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Parti...
    Medical condition: Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 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) SE (Trial now transitioned) FR (Trial now transitioned) CZ (Trial now transitioned) HU (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned) DK (Trial now transitioned) PL (Trial now transitioned) DE (Ongoing) PT (Trial now transitioned) BG (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-005918-17 Sponsor Protocol Number: 69HCL20_0989 Start Date*: 2021-03-30
    Sponsor Name:Hospices Civils de Lyon
    Full Title: Study of how patient pharmacocinetic covariates influence toxicological events of niraparib as ovarian cancer treatment NIRAPK
    Medical condition: Ovarian, tubular or peritoneal high-grade epithelial carcinoma, histologically proven. Recommendation of a maintenance treatment with Niraparib at standard dose (200-300mg/day)
    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: Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004323-72 Sponsor Protocol Number: MedOPP190 Start Date*: 2020-02-05
    Sponsor Name:Medica Scientia Innovation Research (MedSIR)
    Full Title: Multicenter, Open-label, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Niraparib plus Aromatase Inhibitors for Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor...
    Medical condition: Advanced or metastatic HR-positive/HER2-negative breast cancer in patients harboring either gBRCAms or gBRCAwt and HRD.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    21.1 100000004864 10070575 Estrogen receptor positive breast cancer LLT
    20.1 10022891 - Investigations 10077481 Human epidermal growth factor receptor negative PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-004161-13 Sponsor Protocol Number: ZN-c3-006 Start Date*: 2022-04-24
    Sponsor Name:K-Group Beta, Inc.
    Full Title: A Phase 1/2 Dose-Escalation and Dose-Expansion Study of ZN-c3 in Combination with Niraparib in Subjects with Platinum-Resistant Ovarian Cancer
    Medical condition: Platinum-resistant Ovarian Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066697 Ovarian cancer recurrent PT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-000685-11 Sponsor Protocol Number: PR-30-5011-C Start Date*: 2013-09-29
    Sponsor Name:TESARO Inc.
    Full Title: A Phase 3 Randomized Double-Blind Trial of Maintenance with Niraparib Versus Placebo in Patients with Platinum Sensitive Ovarian Cancer
    Medical condition: Platinum Sensitive 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: Female
    Trial protocol: SE (Completed) DE (Completed) AT (Completed) GB (GB - no longer in EU/EEA) DK (Completed) IT (Completed) HU (Completed) ES (Ongoing) BE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-000952-11 Sponsor Protocol Number: PR-30-5017-C Start Date*: 2016-07-01
    Sponsor Name:TESARO, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Base...
    Medical condition: Homologous recombination deficiency advanced 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: Female
    Trial protocol: FI (Trial now transitioned) DK (Trial now transitioned) BE (Trial now transitioned) SE (Trial now transitioned) IE (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) GB (GB - no longer in EU/EEA) HU (Trial now transitioned) CZ (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: View results
    EudraCT Number: 2020-003973-23 Sponsor Protocol Number: 213831 Start Date*: 2021-06-29
    Sponsor Name:GlaxoSmithKline Research and Development Ltd.
    Full Title: A Randomized Phase 3 Double-Blinded Study Comparing the Efficacy and Safety of Niraparib to Placebo in Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer with Mole...
    Medical condition: Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10083232 HER2 negative breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) IE (Completed) PL (Trial now transitioned) NL (Trial now transitioned) FI (Completed) FR (Completed) BE (Completed) DE (Completed) IT (Prematurely Ended) ES (Ongoing) HU (Completed) PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004927-56 Sponsor Protocol Number: SRA737-03 Start Date*: 2018-08-10
    Sponsor Name:Sierra Oncology, Inc.
    Full Title: A Phase 1b/2, Open-label, Multicenter Dose-ranging Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SRA737 in Combination With Niraparib in Subjects...
    Medical condition: Histologically or cytologically confirmed adenocarcinoma of the prostate
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10076506 Castration-resistant prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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