Trial Outcomes & Findings for Vorinostat and Bortezomib in Treating Patients With Progressive, Recurrent Glioblastoma Multiforme (NCT NCT00641706)
NCT ID: NCT00641706
Last Updated: 2014-05-14
Results Overview
Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months. For patients with bidimensionally measurable disease (measurable disease), progression is defined as \> 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. For patients without bidimensionally measurable disease (evaluable disease), progression is defined as unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
At 6 months
Results posted on
2014-05-14
Participant Flow
45 patients were enrolled from 28 medical clinics between July 4, 2008 and February 16, 2010.
One patient cancelled prior to treatment initiation and is excluded in the analysis.
Participant milestones
| Measure |
Arm A (Not Undergoing Surgery)
Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
bortezomib : Given IV
vorinostat : Given orally
|
Arm B (Undergoing Surgery)
Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.
surgery : Patient undergoes therapeutic conventional surgery
bortezomib : Given IV
vorinostat : Given orally
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
7
|
|
Overall Study
COMPLETED
|
28
|
4
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
| Measure |
Arm A (Not Undergoing Surgery)
Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
bortezomib : Given IV
vorinostat : Given orally
|
Arm B (Undergoing Surgery)
Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.
surgery : Patient undergoes therapeutic conventional surgery
bortezomib : Given IV
vorinostat : Given orally
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
1
|
|
Overall Study
Clinical Decline
|
1
|
0
|
|
Overall Study
Lead Investigator Decision
|
0
|
1
|
Baseline Characteristics
Vorinostat and Bortezomib in Treating Patients With Progressive, Recurrent Glioblastoma Multiforme
Baseline characteristics by cohort
| Measure |
Arm A (Not Undergoing Surgery)
n=37 Participants
Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
bortezomib : Given IV
vorinostat : Given orally
|
Arm B (Undergoing Surgery)
n=7 Participants
Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.
surgery : Patient undergoes therapeutic conventional surgery
bortezomib : Given IV
vorinostat : Given orally
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
51 years
n=7 Participants
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
7 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: Patients that started treatment.
Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months. For patients with bidimensionally measurable disease (measurable disease), progression is defined as \> 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. For patients without bidimensionally measurable disease (evaluable disease), progression is defined as unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.
Outcome measures
| Measure |
Arm A (Not Undergoing Surgery)
n=37 Participants
Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
bortezomib : Given IV
vorinostat : Given orally
|
Arm B (Undergoing Surgery)
n=7 Participants
Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.
surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally
|
|---|---|---|
|
Progression-free Survival at 6 Months
|
0 percentage of patients
|
29 percentage of patients
|
SECONDARY outcome
Timeframe: From study registration to date of death due to any cause or last follow-up (up to 5 years)Population: Patients that started treatment.
Estimated using Kaplan-Meier survival curve.
Outcome measures
| Measure |
Arm A (Not Undergoing Surgery)
n=37 Participants
Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
bortezomib : Given IV
vorinostat : Given orally
|
Arm B (Undergoing Surgery)
n=7 Participants
Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.
surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally
|
|---|---|---|
|
Overall Survival
|
3.2 months
Interval 0.7 to 24.8
|
8.7 months
Interval 3.0 to 16.4
|
SECONDARY outcome
Timeframe: From study registration to date of progression (up to 5 years)Population: Patients that started treatment.
Estimated using Kaplan-Meier survival curve. Patients who died were considered to have disease progression at the time of death unless there was documented evidence that no progression occurred before death. For patients with bidimensionally measurable disease (measurable disease), progression is defined as \> 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. For patients without bidimensionally measurable disease (evaluable disease), progression is defined as unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.
Outcome measures
| Measure |
Arm A (Not Undergoing Surgery)
n=37 Participants
Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
bortezomib : Given IV
vorinostat : Given orally
|
Arm B (Undergoing Surgery)
n=7 Participants
Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.
surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally
|
|---|---|---|
|
Time to Progression
|
1.5 months
Interval 0.5 to 5.6
|
4.2 months
Interval 0.6 to 9.3
|
SECONDARY outcome
Timeframe: Assessed up to 5 yearsPopulation: Arm A patients that started treatment. Arm B patients were not analyzed for this outcome because they received surgery and hence response was not measured.
Confidence intervals for the true proportion will be calculated using the exact binomial method. Measurable patients must achieve at least a 50% reduction in the product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose. Evaluable patients must achieve unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose.
Outcome measures
| Measure |
Arm A (Not Undergoing Surgery)
n=37 Participants
Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
bortezomib : Given IV
vorinostat : Given orally
|
Arm B (Undergoing Surgery)
Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.
surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally
|
|---|---|---|
|
Proportion of Confirmed Tumor Response Defined as an Objective Status of Confirmed Response (CR), Partial Response (PR), or Regression (REGR) on Two Consecutive Evaluations
|
0.027 proportion of patients
Interval 0.0007 to 0.14
|
—
|
Adverse Events
Arm A (Not Undergoing Surgery)
Serious events: 18 serious events
Other events: 36 other events
Deaths: 0 deaths
Arm B (Undergoing Surgery)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Not Undergoing Surgery)
n=37 participants at risk
vorinostat : Given orally
|
Arm B (Undergoing Surgery)
n=7 participants at risk
vorinostat : Given orally
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Opportunistic infection
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Sepsis
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Sinusitis
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Skin infection
|
2.7%
1/37 • Number of events 2
|
0.00%
0/7
|
|
Infections and infestations
Urinary tract infection
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Lymphocyte count decreased
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Platelet count decreased
|
32.4%
12/37 • Number of events 13
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
5.4%
2/37 • Number of events 2
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.4%
2/37 • Number of events 2
|
0.00%
0/7
|
|
Nervous system disorders
Ataxia
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Depressed level of consciousness
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Facial nerve disorder
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Memory impairment
|
2.7%
1/37 • Number of events 2
|
0.00%
0/7
|
|
Nervous system disorders
Neurological disorder NOS
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.4%
2/37 • Number of events 2
|
0.00%
0/7
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Seizure
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Speech disorder
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Psychiatric disorders
Confusion
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Psychiatric disorders
Personality change
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Vascular disorders
Hypotension
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
Other adverse events
| Measure |
Arm A (Not Undergoing Surgery)
n=37 participants at risk
vorinostat : Given orally
|
Arm B (Undergoing Surgery)
n=7 participants at risk
vorinostat : Given orally
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
62.2%
23/37 • Number of events 45
|
71.4%
5/7 • Number of events 6
|
|
Cardiac disorders
Sinus bradycardia
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/37
|
14.3%
1/7 • Number of events 3
|
|
Eye disorders
Vision blurred
|
5.4%
2/37 • Number of events 4
|
0.00%
0/7
|
|
Eye disorders
Watering eyes
|
5.4%
2/37 • Number of events 5
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Constipation
|
27.0%
10/37 • Number of events 16
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
24.3%
9/37 • Number of events 13
|
42.9%
3/7 • Number of events 6
|
|
Gastrointestinal disorders
Dry mouth
|
5.4%
2/37 • Number of events 3
|
0.00%
0/7
|
|
Gastrointestinal disorders
Dyspepsia
|
2.7%
1/37 • Number of events 1
|
28.6%
2/7 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/37
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
10.8%
4/37 • Number of events 5
|
0.00%
0/7
|
|
Gastrointestinal disorders
Mucositis oral
|
5.4%
2/37 • Number of events 3
|
0.00%
0/7
|
|
Gastrointestinal disorders
Nausea
|
37.8%
14/37 • Number of events 24
|
57.1%
4/7 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
21.6%
8/37 • Number of events 9
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Edema limbs
|
10.8%
4/37 • Number of events 7
|
0.00%
0/7
|
|
General disorders
Fatigue
|
83.8%
31/37 • Number of events 70
|
71.4%
5/7 • Number of events 15
|
|
General disorders
Pain
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/37
|
14.3%
1/7 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
8.1%
3/37 • Number of events 8
|
0.00%
0/7
|
|
Investigations
Creatinine increased
|
5.4%
2/37 • Number of events 2
|
0.00%
0/7
|
|
Investigations
Leukocyte count decreased
|
29.7%
11/37 • Number of events 16
|
14.3%
1/7 • Number of events 2
|
|
Investigations
Lymphocyte count decreased
|
13.5%
5/37 • Number of events 6
|
28.6%
2/7 • Number of events 3
|
|
Investigations
Neutrophil count decreased
|
18.9%
7/37 • Number of events 7
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Platelet count decreased
|
83.8%
31/37 • Number of events 55
|
71.4%
5/7 • Number of events 11
|
|
Investigations
Weight gain
|
0.00%
0/37
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Weight loss
|
8.1%
3/37 • Number of events 3
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Anorexia
|
21.6%
8/37 • Number of events 12
|
28.6%
2/7 • Number of events 3
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
10.8%
4/37 • Number of events 10
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Dehydration
|
18.9%
7/37 • Number of events 8
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
5.4%
2/37 • Number of events 2
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
2.7%
1/37 • Number of events 2
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
5.4%
2/37 • Number of events 4
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
5.4%
2/37 • Number of events 2
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
8.1%
3/37 • Number of events 3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
8.1%
3/37 • Number of events 7
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/37
|
28.6%
2/7 • Number of events 4
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Ataxia
|
8.1%
3/37 • Number of events 3
|
0.00%
0/7
|
|
Nervous system disorders
Cognitive disturbance
|
2.7%
1/37 • Number of events 2
|
0.00%
0/7
|
|
Nervous system disorders
Depressed level of consciousness
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Dizziness
|
10.8%
4/37 • Number of events 4
|
0.00%
0/7
|
|
Nervous system disorders
Facial nerve disorder
|
2.7%
1/37 • Number of events 2
|
0.00%
0/7
|
|
Nervous system disorders
Headache
|
13.5%
5/37 • Number of events 6
|
0.00%
0/7
|
|
Nervous system disorders
Hydrocephalus
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Memory impairment
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Mini mental status examination abnormal
|
5.4%
2/37 • Number of events 3
|
0.00%
0/7
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.4%
2/37 • Number of events 2
|
0.00%
0/7
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
18.9%
7/37 • Number of events 11
|
0.00%
0/7
|
|
Nervous system disorders
Seizure
|
5.4%
2/37 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Speech disorder
|
5.4%
2/37 • Number of events 3
|
0.00%
0/7
|
|
Nervous system disorders
Taste alteration
|
13.5%
5/37 • Number of events 15
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
5.4%
2/37 • Number of events 5
|
0.00%
0/7
|
|
Psychiatric disorders
Depression
|
2.7%
1/37 • Number of events 2
|
0.00%
0/7
|
|
Psychiatric disorders
Insomnia
|
8.1%
3/37 • Number of events 4
|
0.00%
0/7
|
|
Psychiatric disorders
Libido decreased
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Renal and urinary disorders
Urinary incontinence
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.1%
3/37 • Number of events 3
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.1%
3/37 • Number of events 6
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
5.4%
2/37 • Number of events 2
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.5%
5/37 • Number of events 9
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.1%
3/37 • Number of events 5
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
5.4%
2/37 • Number of events 5
|
0.00%
0/7
|
|
Vascular disorders
Hypertension
|
10.8%
4/37 • Number of events 4
|
0.00%
0/7
|
|
Vascular disorders
Hypotension
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
|
Vascular disorders
Thrombosis
|
2.7%
1/37 • Number of events 1
|
0.00%
0/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60