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Clinical trials for Mitotane

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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    14 result(s) found for: Mitotane. Displaying page 1 of 1.
    EudraCT Number: 2007-007262-38 Sponsor Protocol Number: ADIUVO Start Date*: 2008-03-12
    Sponsor Name:AZIENDA OSPEDALIERA S. LUIGI GONZAGA
    Full Title: Efficacy of adjuvant mitotane treatment in prolonging disease-free survival in patients with adrenocortical cacinoma submitted to radical resection
    Medical condition: PATIENTS WITH ADRENOCORTICAL CARCINOMA SUBMITTED TO RARICAL SURGERY
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001388 Adrenocortical carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing) DE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2005-004137-18 Sponsor Protocol Number: CO-ACT-001 Start Date*: 2007-10-19
    Sponsor Name:Collaborative group for Adrenocortical Carcinoma Therapy (COAT) [...]
    1. Collaborative group for Adrenocortical Carcinoma Therapy (COAT)
    2. University of Würzburg, Internat. study-Coordinator
    Full Title: First International Randomized trial in locally advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)
    Medical condition: chemotherapy with etoposide, doxorubicin and cisplatin plus mitotane (EDP/M) as first line treatment versus streptozotocin plus mitotane (Sz/M) as first line treatment in advanced and Metastatic Ad...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10001388 Adrenocortical carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2018-000580-90 Sponsor Protocol Number: ASSTBS-ONCO-ACACIA-18 Start Date*: 2018-06-20
    Sponsor Name:AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
    Full Title: Multicenter randomized open-label phase III trial of Adjuvant Chemotherapy vs. observation or mitotane after primary surgical resection of localized
    Medical condition: localized Adrenocortical CarcInomA with high risk of recurrence
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001388 Adrenocortical carcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-004354-27 Sponsor Protocol Number: STM2005 Start Date*: 2005-07-13
    Sponsor Name:AZIENDA OSPEDALIERA S. LUIGI GONZAGA
    Full Title: STREPTOZOTOCINE + MITOTANE IN THE TREATMENT OF ADRENO-CORTICAL CANCER PATIENTS PROGRESSED AFTER CHEMOTHERAPY WITH CISPLATIN CONTAINING SCHEME
    Medical condition: Chemotherapy in patients with locally advanced or metastatic adrenocortical cancer
    Disease: Version SOC Term Classification Code Term Level
    6.1 10007284 PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-001125-20 Sponsor Protocol Number: FIRM-ACT Start Date*: 2004-07-26
    Sponsor Name:AZIENDA OSPEDALIERA S. LUIGI GONZAGA
    Full Title: First International Randomized trial in Metastatic Adrenocortical Cancer Treatment FIRM-ACT Etoposide, Doxorubicin, Cisplatin and Mitotane vs. Streptozotocin and Mitotane
    Medical condition: Chemotherapy in patients with locally advanced or metastatic adrenocortical cancer in adults and children
    Disease: Version SOC Term Classification Code Term Level
    6.1 10001378 HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-012820-97 Sponsor Protocol Number: OSI-906-301 Start Date*: 2009-12-29
    Sponsor Name:Astellas Pharma Global Development, Inc.
    Full Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients with Locally Advanced or Metastatic Adrenocortical Carcinoma
    Medical condition: Adrenocortical Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001388 Adrenocortical carcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) FR (Completed) IT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2020-004530-38 Sponsor Protocol Number: ASSTBS-FARONCO-PESETA-20 Start Date*: 2022-05-30
    Sponsor Name:AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
    Full Title: PROSPECTIVE, PHASE II STUDY TO EVALUATE THE EFFICACY OF ADDITION OF PROGESTERONE TO STANDARD CHEMOTHERAPY ACCORDING TO EDP SCHEME PLUS MITOTANE IN PATIENTS WITH ADVANCED ADRENALCORTICAL (PESETA TRIAL)
    Medical condition: advanced/ metastatic patients with ACC
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001388 Adrenocortical carcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003396-19 Sponsor Protocol Number: EOADR1-19 Start Date*: 2020-05-28
    Sponsor Name:Enterome
    Full Title: A phase 1/2 trial of EO2401, a novel microbial-derived peptide therapeutic vaccine, in combination with PD-1 check point blockade, for treatment of patients with locally advanced or metastatic adr...
    Medical condition: - locally advanced or metastatic adrenocortical carcinoma (ACC) - malignant pheochromocytoma/paraganglioma (MPP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001388 Adrenocortical carcinoma PT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10034876 Pheochromocytoma LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075444 Malignant paraganglioma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) NL (Ongoing) ES (Completed) DE (Completed) DK (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-000162-22 Sponsor Protocol Number: 112025-002 Start Date*: 2015-05-04
    Sponsor Name:Laboratoire HRA Pharma
    Full Title: Prospective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed b...
    Medical condition: Treatment of Cushing’s syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10011652 Cushing's syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) BE (Completed) ES (Completed) HU (Completed) PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2018-001802-27 Sponsor Protocol Number: F002MH0218_1 Start Date*: 2019-04-16
    Sponsor Name:University Hospital Wuerzburg
    Full Title: A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Cabozantinib in Advanced (Unresectable or Metastatic) Adrenocortical Carcinoma.
    Medical condition: Advanced (Unresectable or Metastatic) Adrenocortical Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10001353 Adrenal gland disorders HLGT
    20.0 10014698 - Endocrine disorders 10001341 Adrenal cortical hyperfunctions HLT
    20.0 10014698 - Endocrine disorders 10001376 Adrenal neoplasms HLT
    20.0 100000004864 10001378 Adrenal neoplasms malignant HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-001591-35 Sponsor Protocol Number: ASST-ONCO-CABAC2017 Start Date*: 2017-12-27
    Sponsor Name:AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
    Full Title: Multicenter, prospective, non-randomized, phase II trial designed to evaluate the activity of Cabazitaxel in patients with advanced Adreno-Cortical- Carcinoma progressing after previous chemotherap...
    Medical condition: Histologically confirmed diagnosis of ACC Locally advanced or metastatic disease not amenable to radical surgery resection
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061588 Adrenal neoplasm PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-024165-44 Sponsor Protocol Number: CSOM230B2406 Start Date*: 2011-08-05
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape)
    Medical condition: Cushing’s disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10014698 - Endocrine disorders 10011651 Cushing's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GR (Prematurely Ended) ES (Completed) CZ (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2018-001616-30 Sponsor Protocol Number: CORT125134-452 Start Date*: 2018-07-09
    Sponsor Name:Corcept Therapeutics Incorporated
    Full Title: An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome
    Medical condition: Endogenous Cushing Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004860 10011657 Cushings syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Ongoing) BG (Trial now transitioned) DE (Trial now transitioned) IT (Trial now transitioned) NL (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-002133-37 Sponsor Protocol Number: COR-2012-01 Start Date*: 2014-11-17
    Sponsor Name:Cortendo AB
    Full Title: An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome
    Medical condition: Endogenous Cushing's syndrome (CS) or Cushing's disease
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004860 10011657 Cushings syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) BE (Completed) NL (Completed) SE (Completed) DK (Completed) DE (Completed) IT (Completed) BG (Completed) CZ (Completed) HU (Completed)
    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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