Adrenocortical Adenoma, Endometrial Stromal Sarcomas
Conditions
Keywords
Adrenocortical Adenoma,, Endometrial Stromal sarcomas, BGG492
Brief summary
To provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805).
Detailed description
The purpose of the study was to provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805). Data from study CBGG492A2216 was used to support the clinical safety assessment of BGG492 regarding the observance of uterine endometrial stromal tumors and adrenal cortical adenomas at least one year after the completion of BGG492 treatment.
Interventions
PROCEDUREMRI, CT or ultrasound was permitted if MRI was contraindicated
MRI/CT/ultrasound of abdomen
PROCEDUREDexamethasone Supression Test
Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol
PROCEDURESonogram
Sonogram of the uterus (females only)
PROCEDUREBiopsy
Uterine endometrial biopsy (females only)
DRUGBGG492
No study-drug was administered in this study
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent had to be obtained before any assessment was performed; 2. Patients had to be cooperative, willing to participate in the study assessments, and be able to report AEs (adverse events) themselves or have a caregiver who can record and report the events; 3. Total exposure to BGG492 treatment in Study BGG492A2207 and/or BGG492A2212 had to have been greater than 28 days 4. At least 1 year had to have elapsed since the patient received his or her last dose of BGG492.
Exclusion criteria
\- There were no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adrenal Cortical Adenomas | Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212 | Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (CT or ultrasound of the abdomen was permitted if MRI was contraindication) |
| Incidence of Uterine Endometrial Stromal Sarcomas | Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212 | Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females) |
Countries
Germany, Hungary, Italy, Slovakia, South Korea, United States
Participant flow
Recruitment details
The purpose of this follow-up safety study was to provide medical follow-up to patients exposed to BGG492 for more than 28 days in Study BGG492A2207 and/or BGG492A2212.
Pre-assignment details
The first period focused on contacting the patients, obtaining consent for follow-up, and conducting screening assessments. The second period of the study focused on performing the follow-up procedures, obtaining and interpreting the results, and referring the patient, if necessary, to an appropriate medical specialist.
Participants by arm
| Arm | Count |
|---|---|
| BGG492 This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to \> 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day | 59 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | BGG492 |
|---|---|
| Age, Continuous | 43.2 Years STANDARD_DEVIATION 11.58 |
| Gender Female | 31 Participants |
| Gender Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 59 |
| serious Total, serious adverse events | 5 / 59 |
Outcome results
Primary
Incidence of Adrenal Cortical Adenomas
Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (CT or ultrasound of the abdomen was permitted if MRI was contraindication)
Time frame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212
Population: Full analysis Set: included all patients who signed informed consent to enter the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BGG492 | Incidence of Adrenal Cortical Adenomas | 3 Particpants |
Primary
Incidence of Uterine Endometrial Stromal Sarcomas
Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)
Time frame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212
Population: Full Analysis Set (FAS):included all patients who signed informed consent to enter the study, but this assessment was only done on female patients. Of the 31 female patients, two had a hysterectomy and were not evaluated (N=29)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BGG492 | Incidence of Uterine Endometrial Stromal Sarcomas | 0 Participants |