Conditions: Adrenocortical Adenoma Endometrial Stromal Sarcomas
Keywords: Adrenocortical Adenoma, Endometrial Stromal sarcomas BGG492
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 59
Healthy volunteers: no

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.

Arms:
arm 1: 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

Interventions: intervention 1: MRI, CT or ultrasound was permitted if MRI was contraindicated intervention 2: Dexamethasone Supression Test intervention 3: Sonogram intervention 4: Biopsy intervention 5: BGG492
Intervention descriptions: intervention 1: MRI/CT/ultrasound of abdomen intervention 2: Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol intervention 3: Sonogram of the uterus (females only) intervention 4: Uterine endometrial biopsy (females only) intervention 5: No study-drug was administered in this study

Protocol document: