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

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ClinicalTrials.gov Identifier: NCT02150213
Recruitment Status : Completed
First Posted : May 29, 2014
Results First Posted : July 25, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Conditions Adrenocortical Adenoma
Endometrial Stromal Sarcomas
Interventions Procedure: MRI, CT or ultrasound was permitted if MRI was contraindicated
Procedure: Dexamethasone Supression Test
Procedure: Sonogram
Procedure: Biopsy
Drug: BGG492
Enrollment 59
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.
Arm/Group Title BGG492
Hide Arm/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
Period Title: Overall Study
Started 59
Completed 57
Not Completed 2
Reason Not Completed
Lost to Follow-up             1
Withdrawal by Subject             1
Arm/Group Title BGG492
Hide Arm/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
Overall Number of Baseline Participants 59
Hide Baseline Analysis Population Description
Includes all patients who signed the informed consent form for the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants
43.2  (11.58)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Female
31
  52.5%
Male
28
  47.5%
1.Primary Outcome
Title Incidence of Adrenal Cortical Adenomas
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis Set: included all patients who signed informed consent to enter the study
Arm/Group Title BGG492
Hide Arm/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
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: Particpants
3
2.Primary Outcome
Title Incidence of Uterine Endometrial Stromal Sarcomas
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title BGG492
Hide Arm/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
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BGG492
Hide Arm/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
All-Cause Mortality
BGG492
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BGG492
Affected / at Risk (%)
Total   5/59 (8.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adrenal Adenoma  1  3/59 (5.08%) 
Angiomyolipoma  1  1/59 (1.69%) 
Reproductive system and breast disorders   
Ovarian cyst  1  1/59 (1.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BGG492
Affected / at Risk (%)
Total   3/59 (5.08%) 
Renal and urinary disorders   
Renal Cyst  1  3/59 (5.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02150213     History of Changes
Other Study ID Numbers: CBGG492A2216
2013-003431-29 ( EudraCT Number )
First Submitted: May 15, 2014
First Posted: May 29, 2014
Results First Submitted: June 14, 2016
Results First Posted: July 25, 2016
Last Update Posted: December 5, 2016