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Activity of Abiraterone Acetate in the Management of Cushing's Syndrome in Patients With Adrenocortical Carcinoma (ABACUS)

Primary Purpose

Cushing Syndrome, Adrenocortical Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Abiraterone Acetate
Sponsored by
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cushing Syndrome focused on measuring Abiraterone Acetate, Cushing Syndrome, Adrenocortical Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically-confirmed diagnosis of ACC
  • CT or MRI evidence of metastatic or locally advanced ACC (ENSAT stage III-IV) unsuitable for radical surgery
  • Age ≥ 18 years
  • Confirmed diagnosis of Cushing's syndrome validated by:
  • two 24 h urinary collections for UFC at least 1.5 times the upper the normal levels, within 2 weeks prior to enrollment;
  • serum ACTH levels lower than the normal range;
  • ECOG performance status ≤ 2
  • Effective contraception
  • Patients must provide verbal and written informed consent to be enrolled in the study

Exclusion Criteria:

  • Life expectancy less than 3 months
  • Liver disease, such as cirrhosis, chronic or persistent active hepatitis or AST/ALT > 2 x ULN, bilirubin >2 x ULN
  • Heart failure (NYHA class III or IV), unstable angina, severe arrhythmia or clinically significant impairment of heart function
  • Major surgical procedure within one month prior entering the study
  • Renal impairment (creatinine clearance < 40 ml/min).
  • WBC <3 x 109 /L; Hb <13 g/dL for men and <12 g/dL for women; platelets <100 x 109 /L
  • 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 which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  • Pregnant or breast-feeding women
  • History of alcohol or drug abuse
  • History of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years)
  • Acute or chronic uncontrolled infections
  • Patient non-compliance

Sites / Locations

  • U.O Oncologia Medica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

Patients locally advanced/metastatic ACC patients with uncontrolled Cushing's syndrome despite Mitotane +/- chemotherapy. Treatment with single agent Abiraterone Acetate (AA) until progression

Mitotane-naïve patients with newly diagnosis of ACC associated with Cushing's syndrome not amenable to surgical resection. Treatment with single agent Abiraterone Acetate (AA) for 4 weeks followed by AA + Mitotane +/- first-line chemotherapy. AA in association with Mitotane will be administered for 3 months. If the primary endpoint is obtained before 1 month, then Mitotane +/- chemotherapy can be started upon the clinician's decision.

Outcomes

Primary Outcome Measures

To assess the activity of AA in attaining normalization of 24-h urinary free cortisol (UFC) excretion relative to baseline within 1 month from treatment start
laboratory tests

Secondary Outcome Measures

to assess the activity of AA in attaining 50% reduction of 24-h UFC excretion within 1 month of treatment
laboratory tests
time to reduction of UFC (compared to screening values)
laboratory tests (24-h UFC excretion)
effect of AA on levels of serum cortisol, UFC, salivary cortisol, ACTH, aldosterone, PRA, DHEA-S, total testosterone, and steroid precursors
laboratory tests
improvement of the clinical signs associated to hypercortisolism
multiparameter scoring based on clinical signs/and symptoms and biochemical alterations associated to hypercortisolism
improvement of quality of life
evaluation of validated questionnaire (FACT-G)
safety and tolerability of oral assumption of AA
evaluation of side effects appearance with study drug using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE)
treatment response (according to RECIST criteria)
CT total body or MRI scan or FDG PET
progression-free survival
defined as the time elapsing from patient registration to first evidence of disease progression
time to syndrome relapse
defined as the time elapsing from the best syndrome control within the first month to relapse of syndrome defined as: 1) Cushing symptoms recurrence; 2) increase more than 50% of nadir cortisol levels
overall survival
defined as months from the first day of drug administration to the end of follow up or patient's death

Full Information

First Posted
April 26, 2017
Last Updated
May 9, 2017
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Niguarda Hospital, San Camillo Hospital, Rome, San Luigi Gonzaga Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03145285
Brief Title
Activity of Abiraterone Acetate in the Management of Cushing's Syndrome in Patients With Adrenocortical Carcinoma
Acronym
ABACUS
Official Title
Activity of Abiraterone Acetate in the Management of Cushing's Syndrome in Patients With Adrenocortical Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
April 18, 2020 (Anticipated)
Study Completion Date
April 18, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Niguarda Hospital, San Camillo Hospital, Rome, San Luigi Gonzaga Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Adrenocortical Carcinoma (ACC) is an extremely rare disease. Approximately 50% of ACC in adults are functioning leading to hormonal and metabolic syndromes. Cortisol hypersecretion (Cushing's syndrome) is the most common endocrine derangement at presentation. Moreover, hypercortisolism is one of the factors that negatively influence the outcome of patients with metastatic ACC. Abiraterone acetate (AA) is a prodrug of abiraterone, an irreversible inhibitor of 17α hydroxylase/C17, 20-lyase (cytochrome P450c17 [CYP17]).The inhibition of CYP17A1 blocks androgen and cortisol synthesis. AA has a pharmacodynamic potential to reduce cortisol excess and it has never been tested before in Cushing's syndrome. Thus, we decided to evaluate the activity of Abiraterone Acetate in the management of Cushing's syndrome in patients with adrenocortical carcinoma. The study is a phase II, non-randomized, open-label study with two different experimental sub-cohorts: Cohort 1: Patients locally advanced/metastatic ACC patients with uncontrolled Cushing's syndrome despite Mitotane +/- chemotherapy will be treated with single agent AA. In this cohort, Mitotane and chemotherapy will be interrupted and AA will be continued till progression and/or as long as the Cushing's syndrome is adequately controlled (ie until progression of Cushing's syndrome). Cohort 2: Mitotane-naïve patients with newly diagnosis of ACC associated with Cushing's syndrome not amenable to surgical resection with radical intent will be treated with single agent AA for 4 weeks followed by AA + Mitotane +/- first-line chemotherapy. In this cohort, AA in association with Mitotane will be administered for 3 months. If the primary endpoint is obtained before 1 month (i.e. 2 or 3 weeks from Abiraterone start), then Mitotane +/- chemotherapy can be started upon the clinician's decision.
Detailed Description
Background: ACC is an extremely rare disease. About 30% of patients are diagnosed with locally/advanced metastatic disease and about 50-80% of patients who undergo radical resection are destined to relapse often with distant metastases. Approximately 50% of ACC in adults are functioning leading to hormonal and metabolic syndromes. Cortisol hypersecretion (Cushing's syndrome) is the most common endocrine derangement at presentation. Control of the syndrome is mainly obtained by mitotane therapy, however this drug requires several weeks to months for attaining a therapeutic range of serum concentrations. Hypercortisolism is one of the factors that negatively influence the outcome of patients with metastatic ACC. Abiraterone acetate (AA) is a prodrug of abiraterone, an irreversible inhibitor of 17α hydroxylase/C17, 20-lyase (cytochrome P450c17 [CYP17]), that are key enzymes required for testosterone synthesis. These enzymes are found in the testes, adrenals and prostate tumors. The inhibition of CYP17A1 blocks androgen and cortisol synthesis. Abiraterone has demonstrated to be able to suppress dehydroepiandrosterone (DHEA), androstenedione and testosterone production in both adrenal and testes and to reduce adrenal cortisol production. For these reasons Abiraterone is registered for clinical use in castrate-resistant prostate cancer (CRPC). The maximum inhibition of CYP17A1 is achieved within 28 days of continuous dosing. Rationale: A rapid control of the Cushing's syndrome is important in patients with ACC. AA has a pharmacodynamic potential to reduce cortisol excess and it has never been tested before in Cushing's syndrome. Statistical considerations: The sample size in Cohort 1 according to an Intent To Treat (ITT) procedure is calculated under the following considerations: H0: current therapies can normalize UFC in 40% of patients in 1 month of therapy; H1: Abiraterone can normalize UFC in at least 70% of patients in 1 month of therapy. Therefore, the sample size calculation is based on the comparison between the response observed with traditional therapies (R0 = 0.4) and the response expected with the experimental drug (R1 = 0.7). With a two-sided Chi-square test, twenty consecutive patients should be enrolled to detect a 30% absolute difference with an alpha error 5% and a power of 80%. Considering the exploratory purpose of Cohort 2 substudy, no sample size has been determined and a total of 10 patients will be enrolled. Abiraterone administration and dose modifications: Abiraterone Acetate will be administered per os at the standard dose of four 250 mg capsules (1000 mg total dose) daily on an empty stomach in 28-day cycles. In case of an adverse event (AE) where according to investigator judgement a dose-reduction is required, 1 dose reduction is allowed to 500 mg Abiraterone (4→2 tablets). Any return to protocol dose level (4 tablets) after dose reduction must follow documentation of adverse event resolution. Safety and management of AEs: The evaluation period for safety will start from signing of the informed consent form to at least 30 days after the last dose of study drug or recovery from all acute toxicities associated with study drug administration. Adverse events including laboratory AEs will be graded and summarized according to the NCI-CTCAE, Version 4.0. The study will include evaluations of safety according to the time points provided in the Time and Events Schedule.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing Syndrome, Adrenocortical Carcinoma
Keywords
Abiraterone Acetate, Cushing Syndrome, Adrenocortical Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Patients locally advanced/metastatic ACC patients with uncontrolled Cushing's syndrome despite Mitotane +/- chemotherapy. Treatment with single agent Abiraterone Acetate (AA) until progression
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Mitotane-naïve patients with newly diagnosis of ACC associated with Cushing's syndrome not amenable to surgical resection. Treatment with single agent Abiraterone Acetate (AA) for 4 weeks followed by AA + Mitotane +/- first-line chemotherapy. AA in association with Mitotane will be administered for 3 months. If the primary endpoint is obtained before 1 month, then Mitotane +/- chemotherapy can be started upon the clinician's decision.
Intervention Type
Drug
Intervention Name(s)
Abiraterone Acetate
Other Intervention Name(s)
Zytiga
Intervention Description
Cohort 1: Patients locally advanced/metastatic ACC patients with uncontrolled Cushing's syndrome despite Mitotane +/- chemotherapy will be treated with single agent AA.Mitotane and chemotherapy will be interrupted and AA will be continued till progression and/or until progression of Cushing's syndrome. Cohort 2: Mitotane-naïve patients with newly diagnosis of ACC associated with Cushing's syndrome not amenable to surgical resection will be treated with AA for 4 weeks followed by AA + Mitotane +/- first-line chemotherapy. AA in association with Mitotane will be administered for 3 months. If the primary endpoint is obtained before 1 month (i.e. 2 or 3 weeks from Abiraterone start), then Mitotane +/- chemotherapy can be started upon the clinician's decision.
Primary Outcome Measure Information:
Title
To assess the activity of AA in attaining normalization of 24-h urinary free cortisol (UFC) excretion relative to baseline within 1 month from treatment start
Description
laboratory tests
Time Frame
1 month
Secondary Outcome Measure Information:
Title
to assess the activity of AA in attaining 50% reduction of 24-h UFC excretion within 1 month of treatment
Description
laboratory tests
Time Frame
1 month
Title
time to reduction of UFC (compared to screening values)
Description
laboratory tests (24-h UFC excretion)
Time Frame
Weekly, from date of treatment start, for the first month; thereafter every 2 months up to 48 months.
Title
effect of AA on levels of serum cortisol, UFC, salivary cortisol, ACTH, aldosterone, PRA, DHEA-S, total testosterone, and steroid precursors
Description
laboratory tests
Time Frame
Monthly, from date of treatment start, for the first 3 months; thereafter every 2 months up to 48 months
Title
improvement of the clinical signs associated to hypercortisolism
Description
multiparameter scoring based on clinical signs/and symptoms and biochemical alterations associated to hypercortisolism
Time Frame
every visit up to 48 months
Title
improvement of quality of life
Description
evaluation of validated questionnaire (FACT-G)
Time Frame
every visit up to 48 months
Title
safety and tolerability of oral assumption of AA
Description
evaluation of side effects appearance with study drug using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE)
Time Frame
Weekly, from date of treatment start, for the first month; once a month for the first 3 months; thereafter every 2 months up to 48 months
Title
treatment response (according to RECIST criteria)
Description
CT total body or MRI scan or FDG PET
Time Frame
every 3 months or earlier upon clinician's decision, up to 48 months
Title
progression-free survival
Description
defined as the time elapsing from patient registration to first evidence of disease progression
Time Frame
every visit up to 48 months
Title
time to syndrome relapse
Description
defined as the time elapsing from the best syndrome control within the first month to relapse of syndrome defined as: 1) Cushing symptoms recurrence; 2) increase more than 50% of nadir cortisol levels
Time Frame
every visit up to 48 months
Title
overall survival
Description
defined as months from the first day of drug administration to the end of follow up or patient's death
Time Frame
every visit up to 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically-confirmed diagnosis of ACC CT or MRI evidence of metastatic or locally advanced ACC (ENSAT stage III-IV) unsuitable for radical surgery Age ≥ 18 years Confirmed diagnosis of Cushing's syndrome validated by: two 24 h urinary collections for UFC at least 1.5 times the upper the normal levels, within 2 weeks prior to enrollment; serum ACTH levels lower than the normal range; ECOG performance status ≤ 2 Effective contraception Patients must provide verbal and written informed consent to be enrolled in the study Exclusion Criteria: Life expectancy less than 3 months Liver disease, such as cirrhosis, chronic or persistent active hepatitis or AST/ALT > 2 x ULN, bilirubin >2 x ULN Heart failure (NYHA class III or IV), unstable angina, severe arrhythmia or clinically significant impairment of heart function Major surgical procedure within one month prior entering the study Renal impairment (creatinine clearance < 40 ml/min). WBC <3 x 109 /L; Hb <13 g/dL for men and <12 g/dL for women; platelets <100 x 109 /L 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 which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. Pregnant or breast-feeding women History of alcohol or drug abuse History of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years) Acute or chronic uncontrolled infections Patient non-compliance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvatore Grisanti, MD, PhD
Organizational Affiliation
ASST Spedali Civili di Brescia
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.O Oncologia Medica
City
Brescia
State/Province
BS
ZIP/Postal Code
25123
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
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Activity of Abiraterone Acetate in the Management of Cushing's Syndrome in Patients With Adrenocortical Carcinoma

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