Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492

Novartis

Status and phase: Completed; Phase 2

Conditions: Endometrial Stromal Sarcomas; Adrenocortical Adenoma

Treatments: Drug: BGG492; Procedure: Sonogram; Procedure: Biopsy; Procedure: MRI, CT or ultrasound was permitted if MRI was contraindicated; Procedure: Dexamethasone Supression Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT02150213

2013-003431-29 (EudraCT Number)

CBGG492A2216

Details and patient eligibility

About

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).

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 exclusion criteria for this study. All patients meeting the inclusion criteria were eligible to participate in the follow-up safety assessments

Trial design

59 participants in 1 patient group

BGG492

Experimental group

Description:

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

Treatment:

Procedure: MRI, CT or ultrasound was permitted if MRI was contraindicated

Procedure: Biopsy

Procedure: Sonogram

Drug: BGG492

Procedure: Dexamethasone Supression Test