Trial Outcomes & Findings for Phase II Trial Evaluating the Efficacy of Palbociclib in Combination With Carboplatin for the Treatment of Unresectable Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (NCT NCT03194373)

NCT ID: NCT03194373

Last Updated: 2021-04-12

Results Overview

The primary clinical objective of this trial is to estimate disease control rate (DCR) at 12 weeks in patients with metastatic head and neck squamous cell cancer treated with carboplatin and palbociclib. DCR will be defined as either CR (Complete Response: Disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.), PR (Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.) or SD (Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.) at 12 weeks.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

12 weeks

Results posted on

2021-04-12

Participant Flow

One enrolled patient withdrew prior to starting study treatment.

Participant milestones

Participant milestones
Measure	Palbociclib and Carboplatin Treatment with Palbociclib and Carboplatin for up to 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-14 + Carboplatin AUC 5 IV, day 1; cycle length 21 days. Maintenance Palbociclib after 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-21; cycle length 28 days.
Overall Study STARTED	20
Overall Study Received Palbociclib and Carboplatin	19
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

18 patients evaluable for response

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Palbociclib and Carboplatin n=21 Participants Treatment with Palbociclib and Carboplatin for up to 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-14 + Carboplatin AUC 5 IV, day 1; cycle length 21 days. Maintenance Palbociclib after 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-21; cycle length 28 days.
Age, Continuous	65 years n=21 Participants
Sex: Female, Male Female	5 Participants n=21 Participants
Sex: Female, Male Male	16 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=21 Participants
Race (NIH/OMB) White	19 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=21 Participants
ECOG Performance Status 0 (Fully functional)	8 participants n=18 Participants • 18 patients evaluable for response
ECOG Performance Status 1 (Minor impairment)	10 participants n=18 Participants • 18 patients evaluable for response

PRIMARY outcome

Timeframe: 12 weeks

Population: Patients were considered evaluable for response if they underwent response evaluation imaging after 2 cycles of receiving both carboplatin and palbociclib.

Outcome measures

Outcome measures
Measure	Palbociclib and Carboplatin n=18 Participants Treatment with Palbociclib and Carboplatin for up to 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-14 + Carboplatin AUC 5 IV, day 1; cycle length 21 days. Maintenance Palbociclib after 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-21; cycle length 28 days.
Percent Disease Control Rate (DCR)	33 percentage of participants Interval 13.0 to 59.0

SECONDARY outcome

Timeframe: Up to 2 Years

Population: Patients were evaluable for survival if they underwent response evaluation imaging after 2 cycles of receiving both carboplatin and palbociclib.

Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. Estimated using a Kaplan-Meier analysis.

Outcome measures

Outcome measures
Measure	Palbociclib and Carboplatin n=18 Participants Treatment with Palbociclib and Carboplatin for up to 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-14 + Carboplatin AUC 5 IV, day 1; cycle length 21 days. Maintenance Palbociclib after 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-21; cycle length 28 days.
Median Progression Free Survival Time	2.9 months Interval 1.2 to 13.3

SECONDARY outcome

Timeframe: Up to 2 Years

Population: Patients were evaluable for survival if they underwent response evaluation imaging after 2 cycles of receiving both carboplatin and palbociclib.

Overall survival is defined as the time from study enrollment to death from any cause. Estimated using a Kaplan-Meier analysis.

Outcome measures

Outcome measures
Measure	Palbociclib and Carboplatin n=18 Participants Treatment with Palbociclib and Carboplatin for up to 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-14 + Carboplatin AUC 5 IV, day 1; cycle length 21 days. Maintenance Palbociclib after 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-21; cycle length 28 days.
Median Overall Survival Time	4.6 months Interval 1.4 to 14.8

SECONDARY outcome

Timeframe: Up to 2 years

Population: Patients were evaluable for treatment-related toxicities if they underwent response evaluation imaging after 2 cycles of receiving both carboplatin and palbociclib.

Number of adverse events believed to be related (i.e., possibly, probably, or definitely) to palbociclib in combination with carboplatin, reported by grade according to the Common Terminology for Adverse Events version 4.0 (CTCAE v4).

Outcome measures

Outcome measures
Measure	Palbociclib and Carboplatin n=18 Participants Treatment with Palbociclib and Carboplatin for up to 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-14 + Carboplatin AUC 5 IV, day 1; cycle length 21 days. Maintenance Palbociclib after 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-21; cycle length 28 days.
Number of Treatment-related Toxicities Febrile neutropenia : Grade 3-4	1 Participants
Number of Treatment-related Toxicities Neutrophil count decreased : Grade 1-2	2 Participants
Number of Treatment-related Toxicities Neutrophil count decreased : Grade 3-4	10 Participants
Number of Treatment-related Toxicities Anemia : Grade 1-2	5 Participants
Number of Treatment-related Toxicities Anemia : Grade 3-4	7 Participants
Number of Treatment-related Toxicities White blood cell decreased : Grade 1-2	3 Participants
Number of Treatment-related Toxicities White blood cell decreased : Grade 3-4	7 Participants
Number of Treatment-related Toxicities Fatigue : Grade 1-2	7 Participants
Number of Treatment-related Toxicities Fatigue : Grade 3-4	5 Participants
Number of Treatment-related Toxicities Platelet count decreased : Grade 1-2	4 Participants
Number of Treatment-related Toxicities Platelet count decreased : Grade 3-4	3 Participants
Number of Treatment-related Toxicities Nausea : Grade 1-2	6 Participants
Number of Treatment-related Toxicities Nausea : Grade 3-4	2 Participants
Number of Treatment-related Toxicities Vomiting : Grade 1-2	2 Participants
Number of Treatment-related Toxicities Vomiting : Grade 3-4	1 Participants
Number of Treatment-related Toxicities Weight loss : Grade 1-2	4 Participants
Number of Treatment-related Toxicities Weight loss : Grade 3-4	0 Participants
Number of Treatment-related Toxicities Febrile neutropenia : Grade 1-2	0 Participants

Adverse Events

Palbociclib and Carboplatin

Serious events: 14 serious events

Other events: 19 other events

Deaths: 16 deaths

Serious adverse events

Serious adverse events
Measure	Palbociclib and Carboplatin n=19 participants at risk Treatment with Palbociclib and Carboplatin for up to 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-14 + Carboplatin AUC 5 IV, day 1; cycle length 21 days. Maintenance Palbociclib after 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-21; cycle length 28 days.
Blood and lymphatic system disorders Febrile neutropenia	5.3% 1/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Respiratory, thoracic and mediastinal disorders Aspiration	5.3% 1/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Nervous system disorders Ataxia	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.5% 2/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Metabolism and nutrition disorders Hypercalcemia	5.3% 1/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Vascular disorders Hypotension	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Infections and infestations Infections and infestations - other	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Infections and infestations Lung infection	10.5% 2/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Gastrointestinal disorders Nausea	10.5% 2/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - other	15.8% 3/19 • Number of events 3 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Nervous system disorders Nervous system disorders - other	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Investigations Neutrophil count decreased	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
General disorders Pain	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Investigations Platelet count decreased	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	10.5% 2/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Vascular disorders Thromboembolic event	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Gastrointestinal disorders Vomiting	10.5% 2/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Investigations Weight loss	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.

Other adverse events

Other adverse events
Measure	Palbociclib and Carboplatin n=19 participants at risk Treatment with Palbociclib and Carboplatin for up to 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-14 + Carboplatin AUC 5 IV, day 1; cycle length 21 days. Maintenance Palbociclib after 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-21; cycle length 28 days.
Gastrointestinal disorders Abdominal pain	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Renal and urinary disorders Acute kidney injury	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Investigations Alanine aminotransferase increased	26.3% 5/19 • Number of events 5 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Blood and lymphatic system disorders Anemia	63.2% 12/19 • Number of events 28 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Investigations Aspartate aminotransferase increased	21.1% 4/19 • Number of events 5 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Eye disorders Blurred vision	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Musculoskeletal and connective tissue disorders Bone pain	10.5% 2/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Musculoskeletal and connective tissue disorders Chest wall pain	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Gastrointestinal disorders Constipation	21.1% 4/19 • Number of events 5 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Metabolism and nutrition disorders Dehydration	10.5% 2/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Gastrointestinal disorders Diarrhea	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Nervous system disorders Dysgeusia	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Gastrointestinal disorders Dysphagia	15.8% 3/19 • Number of events 3 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	15.8% 3/19 • Number of events 4 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Eye disorders Eye disorders - Other, specify	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Injury, poisoning and procedural complications Fall	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
General disorders Fatigue	63.2% 12/19 • Number of events 20 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
General disorders Flu like symptoms	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Gastrointestinal disorders Gastrointestinal disorders - Other	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
General disorders General disorders and administration site conditions - Other	10.5% 2/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Nervous system disorders Headache	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Metabolism and nutrition disorders Hypercalcemia	15.8% 3/19 • Number of events 4 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Metabolism and nutrition disorders Hyperkalemia	10.5% 2/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Metabolism and nutrition disorders Hypocalcemia	10.5% 2/19 • Number of events 3 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Metabolism and nutrition disorders Hypophosphatemia	5.3% 1/19 • Number of events 3 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Endocrine disorders Hypothyroidism	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Infections and infestations Infections and infestations - Other, specify	10.5% 2/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Investigations Lymphocyte count decreased	31.6% 6/19 • Number of events 10 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Gastrointestinal disorders Mucositis oral	10.5% 2/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	5.3% 1/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Gastrointestinal disorders Nausea	36.8% 7/19 • Number of events 8 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Musculoskeletal and connective tissue disorders Neck pain	10.5% 2/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Nervous system disorders Nervous system disorders - Other, specify	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Investigations Neutrophil count decreased	57.9% 11/19 • Number of events 19 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
General disorders Pain	21.1% 4/19 • Number of events 4 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Nervous system disorders Paresthesia	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Investigations Platelet count decreased	36.8% 7/19 • Number of events 15 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Respiratory, thoracic and mediastinal disorders Postnasal drip	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Skin and subcutaneous tissue disorders Rash acneiform	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Skin and subcutaneous tissue disorders Skin ulceration	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Vascular disorders Thromboembolic event	10.5% 2/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Nervous system disorders Tremor	5.3% 1/19 • Number of events 2 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Musculoskeletal and connective tissue disorders Trismus	5.3% 1/19 • Number of events 1 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Gastrointestinal disorders Vomiting	15.8% 3/19 • Number of events 3 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Investigations Weight loss	26.3% 5/19 • Number of events 5 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.
Investigations White blood cell decreased	52.6% 10/19 • Number of events 20 • Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 months.

Additional Information

Paul Swiecicki, M.D.

University of Michigan Rogel Cancer Center

Phone: 734-647-1017

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place