Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
80
Countries
1
Sites
1
Adrenocortical carcinoma
To assess the activity of the combination regimen (EDP-M plus progesterone (EDP-MP) versus EDP-M plus placebo) in advanced/ metastatic patients with ACC.
Key facts
- Sponsor
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-01-31
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-520160-34-00
- EudraCT number
- 2020-004530-38
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Safety
To assess the activity of the combination regimen (EDP-M plus progesterone (EDP-MP) versus EDP-M plus placebo) in advanced/ metastatic patients with ACC.
Conditions and MedDRA coding
Adrenocortical carcinoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Histologically confirmed diagnosis of ACC
- Locally advanced or metastatic disease not amenable to radical surgery resection
- ECOG performance status 0-2
- Effective contraception
- Life expectancy > 3 months
- Age >= 18 years
- Adequate bone marrow reserve (neutrophils >1,000/mm3 and/or platelets >80,000/mm3) and organ function (including renal, liver and cardiac function)
- Be able to comply with the protocol procedures and provide written informed consent.
Exclusion criteria 8
- History of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, breast ductal carcinoma in situ, or other treated malignancies where there has been no evidence of disease for at least 2 years
- Renal insufficiency (estimated glomerular filtration rate [GFR]<50 mL/min/1.73 m2) or significant liver insufficiency (serum bilirubin>2 times the upper normal range and/or serum alanine aminotransferase [ALT] or aspartate aminotransferase [AST]>3 times the upper normal range). GFRs will be calculated according to the validated formula (MDRD)
- Pregnancy or breast feeding
- Congestive heart failure (ejection fraction<45%)
- Preexisting grade 2 peripheral neuropathy
- Previous or current treatment with mitotane or other antineoplastic drugs for ACC
- Previous radiotherapy for ACC
- Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration or that, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Comparison of proportion of patients attaining an Objective Response (Objective Response Rate, ORR), evaluated by RECIST criteria [29] between the 2 treatment arms.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD2869073 · Product
- Active substance
- Megestrol Acetate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 320 mg milligram(s)
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02AB01 — MEGESTROL
- Marketing authorisation
- 027597020
- MA holder
- PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Change of primary and secondary packaging and label
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 4
SCP119562649 · ATC
- Active substance
- Doxorubicin Hydrochloride
- Route of administration
- IV INFUSION
- Max daily dose
- 40 mg/m2 milligram(s)/square meter
- Max total dose
- 40 mg/m2 milligram(s)/square meter
- Max treatment duration
- 32 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01DB01 — DOXORUBICIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP134220 · ATC
- Active substance
- Cisplatin
- Substance synonyms
- CDDP, Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum
- Route of administration
- IV INFUSION
- Max daily dose
- 40 mg/m2 milligram(s)/sq. meter
- Max total dose
- 40 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 32 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09010MIG · Substance
- Active substance
- Mitotane
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 6 g gram(s)
- Max total dose
- 20 mg/l milligram(s)/litre
- Max treatment duration
- 35 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP100376572 · ATC
- Active substance
- Etoposide
- Route of administration
- IV INFUSION
- Max daily dose
- 100 mg/m2 milligram(s)/square meter
- Max total dose
- 100 mg/m2 milligram(s)/square meter
- Max treatment duration
- 32 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CB01 — ETOPOSIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Sponsor organisation
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Address
- Piazzale Spedali Civili 1
- City
- Brescia
- Postcode
- 25123
- Country
- Italy
Scientific contact point
- Organisation
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Contact name
- Dr. Aldo Maria Roccaro
Public contact point
- Organisation
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Contact name
- Dr. Aldo Maria Roccaro
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 80 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_SM01_2024-520160-34-00 _TC | 3 |
| Protocol (for publication) | D1_Protocol_SM01_2024-520160-34-00_CLEAN | 3 |
| Protocol (for publication) | Protocol PESETA V2 2023 01 26 | 2 |
| Recruitment arrangements (for publication) | INTENTIONALLY LEFT BLANK - PER TRANSIZIONI | 1 |
| Subject information and informed consent form (for publication) | EORTC QLQ C30 V3 | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SM01_2024-520160-34-00 _CLEAN | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SM01_2024-520160-34-00 _TC | 2 |
| Subject information and informed consent form (for publication) | Letter to the GP 2021 05 17 | 1 |
| Subject information and informed consent form (for publication) | Privacy information 2021 05 17 | 1 |
| Subject information and informed consent form (for publication) | Subject information and informed consent form PESETA Ancillary I V1 3 2023 03 16 | 1.3 |
| Subject information and informed consent form (for publication) | Subject information and informed consent form PESETA Ancillary II V1 2023 01 26 | 1 |
| Subject information and informed consent form (for publication) | Subject information and informed consent form PESETA V1 1 2022 01 20 | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | Annex 1 IMPD Megace 160 mg | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_SM01_2024-520160-34-00 _CLEAN | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_SM01_2024-520160-34-00 _TC | 3 |
| Synopsis of the protocol (for publication) | EDPMp sinossi V2 2023 01 26 | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-09 | Italy | Acceptable 2025-01-21
|
2025-01-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-27 | Italy | Acceptable 2025-06-17
|
2025-06-19 |