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Mitotane

DRUG12 trials

Sponsors

Uppsala University Hospital, Assistance Publique Hopitaux De Paris, Universitaetsklinikum Wuerzburg AöR, Unicancer, Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, Collaborative Group for Adrenocortical Carcinoma Treatment, Children's Oncology Group

Conditions

Adrenal CancerAdrenal Cortical CancerAdrenal Cortical CarcinomaAdrenocortical CarcinomaAdrenocortical carcinomaCarcinoma, Adrenal CorticalENSAT Stage I Adrenal Cortex CarcinomaENSAT Stage II Adrenal Cortex Carcinoma

Phase 1

Phase 2

IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery
TerminatedNCT00778817
National Cancer Institute (NCI)Recurrent Adrenocortical Carcinoma, Stage III Adrenocortical Carcinoma, Stage IV Adrenocortical Carcinoma
Start: 2008-12-31End: 2014-03-31Updated: 2014-04-29
A Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination With Mitotane in Patients With Advanced Adrenocortical Carcinoma
TerminatedNCT05634577
M.D. Anderson Cancer CenterAdrenocortical Carcinoma
Start: 2023-03-23End: 2024-07-10Updated: 2025-06-19
Pan-MSI-ACSE: Dostarlimab as first-line treatment for patients with dMMR/MSI (non-colorectal/non-endometrial) locally advanced or metastatic cancer: a randomized phase 2 trial (Cohort Pan-MSI-ACSE) with crossover in the standard arm at progression
RecruitingCTIS2023-505298-34-00
UnicancerPatients with dMMR/MSI (non-colorectal/non-endometrial) locally advanced or metastatic cancer
Start: 2024-07-18Target: 120Updated: 2025-03-04
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 ADRENAL CORTICAL CARCINOMA - PESETA TRIAL
Not yet recruitingCTIS2024-520160-34-00
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di BresciaAdrenocortical carcinoma
Target: 80Updated: 2025-06-19
Phase II Study of PD-1 Inhibitor Combined With Apatinib and Mitotane in the Treatment of Advanced Adrenal Cortical Carcinoma
RecruitingNCT06831175
West China HospitalAdrenal Cancer, Adrenal Cortical Cancer, Adrenal Cortical Carcinoma
Start: 2025-03-15End: 2031-12-31Target: 28Updated: 2025-06-03

Phase 3

Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)
CompletedNCT00094497
Collaborative Group for Adrenocortical Carcinoma TreatmentCarcinoma, Adrenal Cortical
Start: 2004-06-30End: 2010-12-31Updated: 2016-09-21
Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor
CompletedNCT00304070
Children's Oncology GroupStage I Adrenal Cortical Carcinoma AJCC v7, Stage II Adrenal Cortical Carcinoma AJCC v7, Stage III Adrenal Cortical Carcinoma AJCC v7 +1
Start: 2007-05-03End: 2023-06-30Updated: 2024-02-28
Efficacy of Adjuvant Mitotane Treatment (ADIUVO)
NCT00777244
University of Turin, ItalyAdrenocortical Carcinoma
Start: 2008-04-30End: 2020-12-31Target: 200Updated: 2017-05-08
Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence
RecruitingNCT03583710
M.D. Anderson Cancer CenterENSAT Stage I Adrenal Cortex Carcinoma, ENSAT Stage II Adrenal Cortex Carcinoma, ENSAT Stage III Adrenal Cortex Carcinoma
Start: 2018-08-20End: 2029-01-01Target: 240Updated: 2026-01-30
Adjuvant mitotane vs. mitotane with cisplatin/etoposide after primary surgical resection of localised adrenocortical carcinoma with high risk of recurrence (ADIUVO-2 Trial): A pragmatic, randomised, low-intervention phase III, clinical trial with an observational arm.
RecruitingCTIS2022-500013-32-01
Uppsala University Hospital, Assistance Publique Hopitaux De Paris, Universitaetsklinikum Wuerzburg AöRAdrenocortical carcinoma
Start: 2024-07-05Target: 120Updated: 2025-09-16

Unknown Phase

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