Trial Outcomes & Findings for Crizotinib in High-Risk Uveal Melanoma Following Definitive Therapy (NCT NCT02223819)
NCT ID: NCT02223819
Last Updated: 2023-12-06
Results Overview
RFS rate will be defined as the percentage of patients who do not experience any new tumor growth at any site on the body distant from the primary site or death from any cause from the time of study entry to the end of the relevant timepoint. RFS probabilities were estimated using Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
32 Months
Results posted on
2023-12-06
Participant Flow
Participant milestones
| Measure |
Crizotinib
Subjects will receive 48 weeks (12 four-week cycles) of crizotinib 250 mg PO twice a day (BID). Subjects will be evaluated by routine bloodwork and physical exam every 4 weeks while they are receiving crizotinib and during follow up period.
Crizotinib: An anti-cancer drug acting as an anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) inhibitor, used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in a gene called ALK.
Crizotinib will be provided as capsules containing 200 or 250 mg of study medication for oral administration.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Crizotinib
Subjects will receive 48 weeks (12 four-week cycles) of crizotinib 250 mg PO twice a day (BID). Subjects will be evaluated by routine bloodwork and physical exam every 4 weeks while they are receiving crizotinib and during follow up period.
Crizotinib: An anti-cancer drug acting as an anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) inhibitor, used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in a gene called ALK.
Crizotinib will be provided as capsules containing 200 or 250 mg of study medication for oral administration.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Crizotinib in High-Risk Uveal Melanoma Following Definitive Therapy
Baseline characteristics by cohort
| Measure |
Crizotinib
n=34 Participants
Subjects will receive 48 weeks (12 four-week cycles) of crizotinib 250 mg PO twice a day (BID). Subjects will be evaluated by routine bloodwork and physical exam every 4 weeks while they are receiving crizotinib and during follow up period.
Crizotinib: An anti-cancer drug acting as an anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) inhibitor, used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in a gene called ALK.
Crizotinib will be provided as capsules containing 200 or 250 mg of study medication for oral administration.
|
|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
|
Largest basal diameter
|
14.0 mm
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Status
|
0 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 32 MonthsRFS rate will be defined as the percentage of patients who do not experience any new tumor growth at any site on the body distant from the primary site or death from any cause from the time of study entry to the end of the relevant timepoint. RFS probabilities were estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Crizotinib
n=32 Participants
Subjects will receive 48 weeks (12 four-week cycles) of crizotinib 250 mg PO twice a day (BID). Subjects will be evaluated by routine bloodwork and physical exam every 4 weeks while they are receiving crizotinib and during follow up period.
Crizotinib: An anti-cancer drug acting as an anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) inhibitor, used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in a gene called ALK.
Crizotinib will be provided as capsules containing 200 or 250 mg of study medication for oral administration.
|
|---|---|
|
Relapse Free Survival (RFS) Rate at 32 Months
|
50 Probability
Interval 33.0 to 67.0
|
SECONDARY outcome
Timeframe: Up to 36 monthsOS will be defined as the time from treatment start to date of death or last followup. Participants were followed up to 36 months after treatment start and Kaplan-Meier survival analysis was used to generate the Overall Survival estimate.
Outcome measures
| Measure |
Crizotinib
n=32 Participants
Subjects will receive 48 weeks (12 four-week cycles) of crizotinib 250 mg PO twice a day (BID). Subjects will be evaluated by routine bloodwork and physical exam every 4 weeks while they are receiving crizotinib and during follow up period.
Crizotinib: An anti-cancer drug acting as an anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) inhibitor, used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in a gene called ALK.
Crizotinib will be provided as capsules containing 200 or 250 mg of study medication for oral administration.
|
|---|---|
|
Overall Survival (OS)
|
68.3 months
Interval 51.0 to
The upper limit is not applicable due to limited overall survival events at later timepoints.
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Data needed for for DSS calculation (death due to disease) was not collected as participants were no longer actively followed at the time of death.
DSS is defined as the time from treatment start to death due to disease or last followup. Participants who die from other causes will be censored.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksToxicity grading will be performed in accordance with NCI CTCAE, version 4.0.
Outcome measures
| Measure |
Crizotinib
n=32 Participants
Subjects will receive 48 weeks (12 four-week cycles) of crizotinib 250 mg PO twice a day (BID). Subjects will be evaluated by routine bloodwork and physical exam every 4 weeks while they are receiving crizotinib and during follow up period.
Crizotinib: An anti-cancer drug acting as an anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) inhibitor, used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in a gene called ALK.
Crizotinib will be provided as capsules containing 200 or 250 mg of study medication for oral administration.
|
|---|---|
|
Number of Participants With Treatment Discontinuation Due to Toxicity
|
4 Participants
|
Adverse Events
Crizotinib
Serious events: 3 serious events
Other events: 34 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Crizotinib
n=34 participants at risk
Subjects will receive 48 weeks (12 four-week cycles) of crizotinib 250 mg PO twice a day (BID). Subjects will be evaluated by routine bloodwork and physical exam every 4 weeks while they are receiving crizotinib and during follow up period.
Crizotinib: An anti-cancer drug acting as an anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) inhibitor, used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in a gene called ALK.
Crizotinib will be provided as capsules containing 200 or 250 mg of study medication for oral administration.
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Vascular disorders
Thromboembolic event
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Skin and subcutaneous tissue disorders
Left leg and upper back squamous cell carcinomas in situ
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
General disorders
Overdose
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Potential new cancer left renal mass
|
2.9%
1/34 • Number of events 1 • 36 months
|
Other adverse events
| Measure |
Crizotinib
n=34 participants at risk
Subjects will receive 48 weeks (12 four-week cycles) of crizotinib 250 mg PO twice a day (BID). Subjects will be evaluated by routine bloodwork and physical exam every 4 weeks while they are receiving crizotinib and during follow up period.
Crizotinib: An anti-cancer drug acting as an anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) inhibitor, used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in a gene called ALK.
Crizotinib will be provided as capsules containing 200 or 250 mg of study medication for oral administration.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
2/34 • Number of events 2 • 36 months
|
|
Investigations
Alanine aminotransferase increased
|
38.2%
13/34 • Number of events 31 • 36 months
|
|
Investigations
Alkaline phosphatase increased
|
17.6%
6/34 • Number of events 8 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Blood and lymphatic system disorders
Anemia
|
14.7%
5/34 • Number of events 14 • 36 months
|
|
Metabolism and nutrition disorders
Anorexia
|
8.8%
3/34 • Number of events 3 • 36 months
|
|
Psychiatric disorders
Anxiety
|
2.9%
1/34 • Number of events 2 • 36 months
|
|
Investigations
Aspartate aminotransferase increased
|
47.1%
16/34 • Number of events 26 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
2/34 • Number of events 2 • 36 months
|
|
Gastrointestinal disorders
Bloating
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Blood and lymphatic system disorders
Elevated liver enzymes
|
5.9%
2/34 • Number of events 3 • 36 months
|
|
Eye disorders
Blurred vision
|
5.9%
2/34 • Number of events 2 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
General disorders
Chills
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.9%
1/34 • Number of events 4 • 36 months
|
|
Gastrointestinal disorders
Constipation
|
35.3%
12/34 • Number of events 16 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.6%
6/34 • Number of events 8 • 36 months
|
|
Investigations
Creatine phosphokinase (CPK) Increased
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Investigations
Creatinine increased
|
23.5%
8/34 • Number of events 18 • 36 months
|
|
Psychiatric disorders
Depression
|
8.8%
3/34 • Number of events 3 • 36 months
|
|
Gastrointestinal disorders
Diarrhea
|
61.8%
21/34 • Number of events 48 • 36 months
|
|
Nervous system disorders
Dizziness
|
32.4%
11/34 • Number of events 13 • 36 months
|
|
Gastrointestinal disorders
Dry Mouth
|
5.9%
2/34 • Number of events 2 • 36 months
|
|
Nervous system disorders
Dysgeusia
|
17.6%
6/34 • Number of events 6 • 36 months
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Dyspepsia
|
20.6%
7/34 • Number of events 9 • 36 months
|
|
Gastrointestinal disorders
Dysphagia
|
8.8%
3/34 • Number of events 3 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
2/34 • Number of events 4 • 36 months
|
|
General disorders
Edema limbs
|
35.3%
12/34 • Number of events 13 • 36 months
|
|
General disorders
Edema trunk
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
5.9%
2/34 • Number of events 3 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Esophagitis
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Eye disorders
Diplopia
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
General disorders
Fatigue
|
52.9%
18/34 • Number of events 30 • 36 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
General disorders
Fever
|
5.9%
2/34 • Number of events 2 • 36 months
|
|
Eye disorders
Flashing lights
|
11.8%
4/34 • Number of events 6 • 36 months
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
2/34 • Number of events 2 • 36 months
|
|
Eye disorders
Floaters
|
17.6%
6/34 • Number of events 6 • 36 months
|
|
General disorders
Flu like symptoms
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Fracture
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
General disorders
Gait disturbance
|
2.9%
1/34 • Number of events 4 • 36 months
|
|
Gastrointestinal disorders
Gastritis
|
2.9%
1/34 • Number of events 2 • 36 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
11.8%
4/34 • Number of events 4 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.9%
2/34 • Number of events 2 • 36 months
|
|
Eye disorders
Glaucoma
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Nervous system disorders
Headache
|
8.8%
3/34 • Number of events 3 • 36 months
|
|
Renal and urinary disorders
Hematuria
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Hepatobiliary disorders
Hepatic hemorrhage
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Hepatobiliary disorders
Elevated Lactate Dehydrogenase (LDH)
|
35.3%
12/34 • Number of events 14 • 36 months
|
|
Vascular disorders
Hot flashes
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
17.6%
6/34 • Number of events 30 • 36 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
17.6%
6/34 • Number of events 10 • 36 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Vascular disorders
Hypertension
|
14.7%
5/34 • Number of events 12 • 36 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
32.4%
11/34 • Number of events 30 • 36 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.6%
7/34 • Number of events 18 • 36 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.8%
3/34 • Number of events 6 • 36 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.8%
3/34 • Number of events 4 • 36 months
|
|
Vascular disorders
Hypotension
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Psychiatric disorders
Insomnia
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
General disorders
Irritability
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Psychiatric disorders
Libido decreased
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
General disorders
Localized edema
|
14.7%
5/34 • Number of events 6 • 36 months
|
|
Vascular disorders
Lymphedema
|
2.9%
1/34 • Number of events 2 • 36 months
|
|
Investigations
Lymphocyte count decreased
|
8.8%
3/34 • Number of events 4 • 36 months
|
|
General disorders
Malaise
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
2/34 • Number of events 2 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Nausea
|
55.9%
19/34 • Number of events 24 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Investigations
Neutrophil count decreased
|
2.9%
1/34 • Number of events 3 • 36 months
|
|
General disorders
Pain
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Cardiac disorders
Palpitations
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Infections and infestations
Papulopustular rash
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Nervous system disorders
Paresthesia
|
5.9%
2/34 • Number of events 3 • 36 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Investigations
Platelet count decreased
|
5.9%
2/34 • Number of events 4 • 36 months
|
|
Nervous system disorders
Presyncope
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.9%
2/34 • Number of events 3 • 36 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
2/34 • Number of events 5 • 36 months
|
|
Renal and urinary disorders
Renal calculi
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Retinoic acid syndrome
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Eye disorders
Scleral disorder
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Cardiac disorders
Sinus bradycardia
|
44.1%
15/34 • Number of events 21 • 36 months
|
|
Infections and infestations
Sinusitis
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Infections and infestations
Skin infection
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Nervous system disorders
Syncope
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Vascular disorders
Thromboembolic event
|
5.9%
2/34 • Number of events 2 • 36 months
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Nervous system disorders
Tremor
|
2.9%
1/34 • Number of events 2 • 36 months
|
|
Infections and infestations
Upper respiratory infection
|
8.8%
3/34 • Number of events 3 • 36 months
|
|
Renal and urinary disorders
Urinary incontinence
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.9%
2/34 • Number of events 2 • 36 months
|
|
Renal and urinary disorders
Uterine infection
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Vomiting
|
20.6%
7/34 • Number of events 8 • 36 months
|
|
Investigations
Weight gain
|
5.9%
2/34 • Number of events 3 • 36 months
|
|
Investigations
Weight loss
|
5.9%
2/34 • Number of events 2 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Investigations
White blood cell decreased
|
20.6%
7/34 • Number of events 7 • 36 months
|
|
Psychiatric disorders
Attention Deficit Hyperactivity Disorder
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Investigations
Cataract surgery
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Investigations
Colonoscopy
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Hepatobiliary disorders
Elevated transaminases
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Investigations
Endoscopy
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Blood and lymphatic system disorders
Eosinophilia
|
5.9%
2/34 • Number of events 2 • 36 months
|
|
Skin and subcutaneous tissue disorders
Herpes Zoster
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Investigations
Hypochloremia
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Investigations
Hypoproteinemia
|
5.9%
2/34 • Number of events 2 • 36 months
|
|
Eye disorders
Intermittent visual disturbance, left eye
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Investigations
Interstitial lung disease
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Renal and urinary disorders
Kidney pain with pressure during urination
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Investigations
Left Hip Pain
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Investigations
Leukopenia
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Nervous system disorders
Migraine
|
2.9%
1/34 • Number of events 2 • 36 months
|
|
Investigations
Neutrophil count increased (neutrophilia)
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Eye disorders
Palinopsia
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polyp
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Vascular disorders
Pulmonary embolus
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Investigations
Shortness of breath
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Uncontrolled Diarrhea
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Eye disorders
Vision loss
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Eye disorders
Visual disturbances
|
2.9%
1/34 • Number of events 1 • 36 months
|
|
Eye disorders
Visual disturbances (double vision)
|
2.9%
1/34 • Number of events 1 • 36 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place