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Clinical trials for Ipatasertib

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
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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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    19 result(s) found for: Ipatasertib. Displaying page 1 of 1.
    EudraCT Number: 2017-001548-36 Sponsor Protocol Number: CO40016 Start Date*: 2017-12-18
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED PHASE III STUDY OF IPATASERTIB IN COMBINATION WITH PACLITAXEL AS A TREATMENT FOR PATIENTS WITH PIK3CA/AKT1/PTEN-ALTERED, LOCALLY ADVANCED OR METASTATI...
    Medical condition: Locally advanced unresectable or metastatic triple-negative (estrogen receptor, progesterone receptor, and HER2 negative) breast cancer or locally advanced unresectable or metastatic hormone recept...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    21.1 100000004864 10072740 Locally advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing) GB (GB - no longer in EU/EEA) CZ (Completed) HU (Completed) PL (Completed) BE (Completed) FR (Completed) GR (Completed) SI (Completed) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2019-001072-11 Sponsor Protocol Number: CO41012 Start Date*: 2019-08-21
    Sponsor Name:Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
    Full Title: A PHASE IB/III STUDY OF IPATASERTIB PLUS PALBOCICLIB AND FULVESTRANT VERSUS PLACEBO PLUS PALBOCICLIB AND FULVESTRANT IN HORMONE RECEPTOR POSITIVE AND HER2 NEGATIVE LOCALLY ADVANCED UNRESECTABLE OR ...
    Medical condition: Hormone receptor (HR)-positive/HER2-negative locally advanced unresectable or metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    20.0 100000004864 10072740 Locally advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-004429-17 Sponsor Protocol Number: CO39303 Start Date*: 2018-09-19
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER TRIAL TESTING IPATASERTIB PLUS ABIRATERONE PLUS PREDNISONE/PREDNISOLONE, RELATIVE TO PLACEBO PLUS ABIRATERONE PLUS PREDNISONE/...
    Medical condition: Metastatic Castrate-Resistant Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10076506 Castration-resistant prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NO (Completed) PT (Completed) DE (Completed) DK (Completed) HU (Ongoing) GB (GB - no longer in EU/EEA) AT (Completed) IE (Completed) BE (Completed) ES (Ongoing) GR (Ongoing) PL (Completed) FR (Completed) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2014-000469-35 Sponsor Protocol Number: GO29227 Start Date*: 2014-08-12
    Sponsor Name:Genentech, Inc.
    Full Title: A RANDOMIZED, PHASE II, MULTICENTER, PLACEBO-CONTROLLED STUDY OF IPATASERTIB (GDC-0068), AN INHIBITOR OF AKT, IN COMBINATION WITH PACLITAXEL AS FRONT-LINE TREATMENT FOR PATIENTS WITH METASTATIC TRI...
    Medical condition: Inoperable locally advanced or metastatic triple negative breast cancer
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10027475 Metastatic breast cancer LLT
    17.0 100000004864 10072740 Locally advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Completed) BE (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-003029-16 Sponsor Protocol Number: GO29505 Start Date*: 2014-12-01
    Sponsor Name:Genentech, Inc.
    Full Title: A phase II randomized, double-blind study of ipatasertib (GDC-0068), an inhibitor to Akt in combination with paclitaxel as neoadjuvant treatment for patients with early stage triple negative breast...
    Medical condition: Early stage triple negative breast cancer.
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2022-003414-36 Sponsor Protocol Number: BX44273 Start Date*: 2023-09-11
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: AN OPEN LABEL, MULTICENTER EXTENSION STUDY FOR PATIENTS PREVIOSULY ENROLLED IN A GENENTECH AND/OR F. HOFFMAN-LA ROCHE SPONSORED STUDY
    Medical condition: There is no medical condition being investigated. As this is an extension study designed to provide continued treatment for eligible patients who were previously enrolled and treated in a Genentech...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-000810-12 Sponsor Protocol Number: CO41101 Start Date*: 2019-12-09
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY OF IPATASERTIB IN COMBINATION WITH ATEZOLIZUMAB AND PACLITAXEL AS A TREATMENT FOR PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR META...
    Medical condition: Metastatic triple-negative breast cancer (TNBC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    21.1 100000004864 10072740 Locally advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) FR (Completed) AT (Completed) PL (Completed) PT (Completed) IE (Prematurely Ended) ES (Completed) FI (Completed) HU (Ongoing) BE (Completed) GR (Prematurely Ended) BG (Completed) DK (Completed) RO (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000977-62 Sponsor Protocol Number: 012418QM Start Date*: 2018-09-28
    Sponsor Name:Queen Mary University of London
    Full Title: BARBICAN: A randomised, open-label Phase II study to determine the contribution of ipatasertib to neoadjuvant chemotherapy plus atezolizumab in women with triple-negative breast cancer
    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) 10057654 Breast cancer female PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003040-20 Sponsor Protocol Number: MX39795 Start Date*: 2018-06-20
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A phase II, randomized, active-controlled, multi-center study comparing the efficacy and safety of targeted therapy or cancer immunotherapy guided by genomic profiling versus platinum-based chemoth...
    Medical condition: Cancer of Unknown Primary Site
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10032248 Other malignant neoplasm of unspecified site LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) AT (Ongoing) EE (Completed) IE (Completed) DE (Temporarily Halted) CZ (Ongoing) FI (Ongoing) LV (Completed) HU (Ongoing) PL (Completed) FR (Ongoing) ES (Ongoing) BG (Ongoing) PT (Ongoing) HR (Ongoing) NL (Ongoing) DK (Completed) CY (Prematurely Ended) IT (Ongoing) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2018-004648-44 Sponsor Protocol Number: MedOPP253 Start Date*: 2020-07-06
    Sponsor Name:Medica Scientia Innovation Research S.L (MEDSIR)
    Full Title: A multicentre, Open-Label, Non-comparative, three-arm, phase IIa trial of Ipatasertib (GDC-0068) in Combination with non-Taxane chemotherapy agents for taxane-pre...
    Medical condition: UNRESECTABLE LOCALLY ADVANCED OR METASTATIC RIPLE-NEGATIVE BREAST CANCER PATIENTS
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10072740 Locally advanced breast cancer LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075566 Triple negative breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003192-18 Sponsor Protocol Number: NCT-PMO-1602 Start Date*: 2021-07-08
    Sponsor Name:German Cancer Research Center
    Full Title: Continuous ReAssessment with Flexible ExTension in Rare Malignancies – CRAFT: The NCT PMO-1602 Phase II Trial
    Medical condition: Metastatic or locally advanced malignancies
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065147 Malignant solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-004424-38 Sponsor Protocol Number: 011604QM Start Date*: 2017-11-16
    Sponsor Name:Queen Mary University of London
    Full Title: A phase II study investigating preoperative combination strategies for immunotherapy in patients with untreated, operable ER+, HER2-negative primary breast cancer.
    Medical condition: Untreated, operable ER+, HER2-negative primary breast cancer.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-004126-10 Sponsor Protocol Number: GO27983 Start Date*: 2012-04-19
    Sponsor Name:Genentech Inc.
    Full Title: A PHASE Ib/II STUDY OF GDC-0068 OR GDC-0980 WITH ABIRATERONE ACETATE VERSUS ABIRATERONE ACETATE IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH DOCETAXEL-BASED CHEMOTH...
    Medical condition: Castration-Resistant Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GR (Completed) CZ (Completed) ES (Completed) GB (GB - no longer in EU/EEA) NL (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-000297-17 Sponsor Protocol Number: 69HCL19_0153 Start Date*: 2021-01-21
    Sponsor Name:Hospices Civils de Lyon
    Full Title: IMMUNOGAST: An umbrella phase 2 trial to assess personalized targeted IMMUNOtherapy-based regimens in recurrent advanced/metastatic GASTric adenocarcinoma patients
    Medical condition: For patients with advanced/metastatic gastric adenocarcinomas in progression
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10071114 Metastatic gastric adenocarcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002038-21 Sponsor Protocol Number: CO40115 Start Date*: 2018-05-01
    Sponsor Name:F. Hoffman-La Roche Ltd.
    Full Title: A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC TRIPLE-NEGATI...
    Medical condition: Triple-negative breast cancer (TNBC)
    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 (Ongoing) FR (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-001847-16 Sponsor Protocol Number: BO41932 Start Date*: 2021-03-18
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL
    Medical condition: Locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are TMB-high as identified by a validated NGS assay
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065147 Malignant solid tumor LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065252 Solid tumor LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Ongoing) DE (Restarted) BE (Ongoing) PT (Ongoing) PL (Ongoing) FR (Ongoing) NL (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-002190-21 Sponsor Protocol Number: MAR-BAS-18-005 Start Date*: 2020-07-08
    Sponsor Name:Fondazione per la Medicina Personalizzata
    Full Title: The ROME trial from histology to target: the road to personalize target therapy and immunotherapy
    Medical condition: Patients with progressive disease (recurrent and/or metastatic) of breast cancer, metastatic gastro-intestinal tumors, non small cell lung cancer (NSCLC) or others. Patients should have completed a...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066275 Comedocarcinoma of breast LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007351 Carcinoma gastrointestinal LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10071533 Lung squamous cell carcinoma metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004936-72 Sponsor Protocol Number: WO42178 Start Date*: 2021-08-25
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE II, OPEN-LABEL, MULTICENTER, PLATFORM STUDY EVALUATING THE EFFICACY AND SAFETY OF BIOMARKER-DRIVEN THERAPIES IN PATIENTS WITH PERSISTENT OR RECURRENT RARE EPITHELIAL OVARIAN TUMORS
    Medical condition: Persistent or Recurrent Rare Epithelial Ovarian Tumors
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033129 Ovarian neoplasms malignant (excl germ cell) HLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066697 Ovarian cancer recurrent PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10026669 Malignant peritoneal neoplasm NOS LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033159 Ovarian epithelial cancer NOS LLT
    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: FR (Trial now transitioned) CZ (Trial now transitioned) DE (Trial now transitioned) BE (Completed) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-001267-21 Sponsor Protocol Number: BO39610 Start Date*: 2018-01-25
    Sponsor Name:F. Hoffman-La Roche Ltd.
    Full Title: A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC NONSMALL CEL...
    Medical condition: Metastatic non-small cell lung cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    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) ES (Ongoing) FR (Ongoing)
    Trial results: (No results available)
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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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