Clinical trial • Phase II • Oncology

MEGESTROL ACETATE for Adrenocortical carcinoma

Phase II trial of MEGESTROL ACETATE for Adrenocortical carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Adrenocortical carcinoma
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
09-01-2025
First CTIS Authorization Date
31-01-2025

Trial design

EDP-M plus placebo (EDP-M = etoposide + doxorubicin + cisplatin + mitotane) plus placebo ("The placebo prepared for the study consists in oval shaped biconvexed tablets that are scored on one side an engraved with \"160\" on the other side.")-controlled Phase II trial across 1 site in Italy.

Comparator
EDP-M plus placebo (EDP-M = etoposide + doxorubicin + cisplatin + mitotane) plus placebo ("The placebo prepared for the study consists in oval shaped biconvexed tablets that are scored on one side an engraved with \"160\" on the other side.")
Target Sample Size
80

Eligibility

Recruits 80 Vulnerable population selected. Participants must "provide written informed consent." Subject information and informed consent form documents are listed for the trial..

Pregnancy Exclusion
Pregnancy or breast feeding
Vulnerable Population
Vulnerable population selected. Participants must "provide written informed consent." Subject information and informed consent form documents are listed for the trial.

Inclusion criteria

  • {"criterion_text":"- Histologically confirmed diagnosis of ACC\n- Locally advanced or metastatic disease not amenable to radical surgery resection\n- ECOG performance status 0-2\n- Effective contraception\n- Life expectancy > 3 months\n- Age >= 18 years\n- Adequate bone marrow reserve (neutrophils >1,000/mm3 and/or platelets >80,000/mm3) and organ function (including renal, liver and cardiac function)\n- Be able to comply with the protocol procedures and provide written informed consent."}

Exclusion criteria

  • {"criterion_text":"- 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\n- 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)\n- Pregnancy or breast feeding\n- Congestive heart failure (ejection fraction<45%)\n- Preexisting grade 2 peripheral neuropathy\n- Previous or current treatment with mitotane or other antineoplastic drugs for ACC\n- Previous radiotherapy for ACC\n- 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 endpoints

  • {"endpoint_text":"- Comparison of proportion of patients attaining an Objective Response (Objective Response Rate, ORR), evaluated by RECIST criteria [29] between the 2 treatment arms.","definition_or_measurement_approach":"Objective Response Rate (ORR) evaluated by RECIST criteria, comparison of proportion of patients with objective response between the two treatment arms."}

Recruitment

Planned Sample Size
80
Recruitment Window Months
75
Consent Approach
Participants must be able to comply with the protocol procedures and provide written informed consent. Subject information and informed consent form documents are listed in the trial documentation. Age requirement is >= 18 years; no assent process for minors is described.

Geography

Total Number Of Sites
1
Total Number Of Participants
80

Italy

Earliest CTIS Part Ii Submission Date
10-12-2024
Latest Decision Or Authorization Date
19-06-2025
Processing Time Days
191
Number Of Sites
1
Number Of Participants
80

Sites

Site Name
ASST Spedali Civili di Brescia
Department Name
Oncology
Contact Person Name
Salvatore Grisanti
Contact Person Email
salvatore.grisanti@unibs.it

Sponsor

Primary sponsor

Full Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
MEGACE 160 mg compresse
Active Substance
MEGESTROL ACETATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
027597020
Maximum Dose
320 mg
Investigational Product Name
The placebo prepared for the study consists in oval shaped biconvexed tablets that are scored on one side an engraved with "160" on the other side.
Modality
Other
Investigational Product Name
DOXORUBICIN
Active Substance
DOXORUBICIN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
-
Maximum Dose
40 mg/m2
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
-
Maximum Dose
40 mg/m2
Investigational Product Name
ETOPOSIDE
Active Substance
ETOPOSIDE
Modality
Small molecule
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
-
Maximum Dose
100 mg/m2
Investigational Product Name
MITOTANE
Active Substance
MITOTANE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
-
Maximum Dose
6 g (max daily dose amount field provided as 6 g)
Combination Treatment
Yes

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