Trial Outcomes & Findings for Phase II Trial of Nelfinavir With Concurrent Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck (NCT NCT02207439)
NCT ID: NCT02207439
Last Updated: 2023-07-25
Results Overview
locoregional control determined via diagnostic imaging and clinical examination.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
5 years
Results posted on
2023-07-25
Participant Flow
Participant milestones
| Measure |
Single Arm, 2 Period, Phase 2 Trial
Period 1: Nelfinavir Lead-In (1250 mg bid, 7-14 days)
Period 2: Definitive Chemoradiotherapy with Nelfinavir (70 Gy radiotherapy over 7 weeks)
|
|---|---|
|
Nelfinavir Lead-In
STARTED
|
17
|
|
Nelfinavir Lead-In
COMPLETED
|
17
|
|
Nelfinavir Lead-In
NOT COMPLETED
|
0
|
|
Chemoradiotherapy With Nelfinavir
STARTED
|
17
|
|
Chemoradiotherapy With Nelfinavir
COMPLETED
|
17
|
|
Chemoradiotherapy With Nelfinavir
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Trial of Nelfinavir With Concurrent Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck
Baseline characteristics by cohort
| Measure |
Single Arm Phase 2
n=17 Participants
Nelfinavir (Viracept®) 1250 mg
FMISO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
|
Locoregional head and neck cancer
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearslocoregional control determined via diagnostic imaging and clinical examination.
Outcome measures
| Measure |
Single Arm Phase 2
n=17 Participants
Locoregional Control
|
|---|---|
|
Locoregional Control
|
17 participants
Interval 11.0 to 17.0
|
SECONDARY outcome
Timeframe: 7-14 daysDecrease in Hypoxia from Nelfinavir was determined by change in uptake and volume as assessed via 18f-FMISO or 18f-EF5 PET/CT pre-Nelfinavir versus post Nelfnavir lead-in
Outcome measures
| Measure |
Single Arm Phase 2
n=12 Participants
Locoregional Control
|
|---|---|
|
Decrease in Hypoxia From Nelfinavir
|
12 participants
Interval 8.0 to 12.0
|
SECONDARY outcome
Timeframe: From the initiation of any study procedures to 30 days following the completion of 7 chemoradiationChange in Glucose Metabolism from Nelfinavir was determined by change in glucose uptake as assessed via FDG-PET/CT pre-Nelfinavir versus post Nelfnavir lead-in
Outcome measures
| Measure |
Single Arm Phase 2
n=17 Participants
Locoregional Control
|
|---|---|
|
Change in Glucose Metabolism From Nelfinavir
|
17 Participants
|
Adverse Events
Single Arm Phase 2
Serious events: 17 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm Phase 2
n=17 participants at risk
Nelfinavir (Viracept®) 1250 mg
FMISO
|
|---|---|
|
Nervous system disorders
Dysgeusia
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Immune system disorders
Allergic reaction
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Blood and lymphatic system disorders
Anemia
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Metabolism and nutrition disorders
Anorexia
|
11.8%
2/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
11.8%
2/17 • Number of events 5 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Hepatobiliary disorders
Cholecystitis
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Gastrointestinal disorders
Dysphagia
|
11.8%
2/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Gastrointestinal disorders
Esophagitis
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.6%
3/17 • Number of events 3 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Investigations
Lymphocyte count decreased
|
29.4%
5/17 • Number of events 9 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Gastrointestinal disorders
Mucositis oral
|
17.6%
3/17 • Number of events 3 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Investigations
Neutrophil count decreased
|
5.9%
1/17 • Number of events 3 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Investigations
Platelet count decreased
|
5.9%
1/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Cardiac disorders
Sinus bradycardia
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Investigations
White blood cell decreased
|
5.9%
1/17 • Number of events 46 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
Other adverse events
| Measure |
Single Arm Phase 2
n=17 participants at risk
Nelfinavir (Viracept®) 1250 mg
FMISO
|
|---|---|
|
Psychiatric disorders
Agitation
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Investigations
Alanine aminotransferase increased
|
17.6%
3/17 • Number of events 4 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Investigations
Alkaline phosphatase increased
|
11.8%
2/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Immune system disorders
Allergic reaction
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.6%
3/17 • Number of events 3 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Blood and lymphatic system disorders
Anemia
|
47.1%
8/17 • Number of events 17 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Metabolism and nutrition disorders
Anorexia
|
52.9%
9/17 • Number of events 17 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Psychiatric disorders
Anxiety
|
17.6%
3/17 • Number of events 4 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
11.8%
2/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Gastrointestinal disorders
Constipation
|
47.1%
8/17 • Number of events 9 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.5%
4/17 • Number of events 4 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Investigations
Creatinine increased
|
11.8%
2/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Metabolism and nutrition disorders
Dehydration
|
11.8%
2/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Psychiatric disorders
Depression
|
11.8%
2/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
82.4%
14/17 • Number of events 21 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Gastrointestinal disorders
Diarrhea
|
47.1%
8/17 • Number of events 8 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Nervous system disorders
Dizziness
|
17.6%
3/17 • Number of events 3 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Gastrointestinal disorders
Dry mouth
|
47.1%
8/17 • Number of events 8 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Nervous system disorders
Dysgeusia
|
88.2%
15/17 • Number of events 22 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Gastrointestinal disorders
Dysphagia
|
64.7%
11/17 • Number of events 17 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.8%
2/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Ear and labyrinth disorders
Ear pain
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
General disorders
Edema face
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
General disorders
Edema limbs
|
11.8%
2/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
23.5%
4/17 • Number of events 4 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Skin and subcutaneous tissue disorders
Esophageal pain
|
5.9%
1/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
General disorders
Fatigue
|
64.7%
11/17 • Number of events 17 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
General disorders
Fever
|
11.8%
2/17 • Number of events 3 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Gastrointestinal disorders
Gastroparesis
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
11.8%
2/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.9%
1/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.9%
1/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
23.5%
4/17 • Number of events 6 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.8%
2/17 • Number of events 5 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
23.5%
4/17 • Number of events 6 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Metabolism and nutrition disorders
Hyponatremia
|
29.4%
5/17 • Number of events 8 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
General disorders
Localized edema
|
5.9%
1/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Investigations
Lymphocyte count decreased
|
11.8%
2/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Investigations
Lymphocyte count increased
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
5.9%
1/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Gastrointestinal disorders
Mucositis oral
|
52.9%
9/17 • Number of events 13 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Gastrointestinal disorders
Nausea
|
41.2%
7/17 • Number of events 7 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
General disorders
Neck edema
|
41.2%
7/17 • Number of events 8 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
17.6%
3/17 • Number of events 3 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Gastrointestinal disorders
Oral pain
|
17.6%
3/17 • Number of events 3 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
General disorders
Pain
|
29.4%
5/17 • Number of events 8 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Investigations
Platelet count decreased
|
11.8%
2/17 • Number of events 5 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Reproductive system and breast disorders
Prostatic pain
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
58.8%
10/17 • Number of events 14 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Nervous system disorders
Somnolence
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Gastrointestinal disorders
Stomach pain
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Vascular disorders
Thromboembolic event
|
5.9%
1/17 • Number of events 1 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Ear and labyrinth disorders
Tinnitus
|
17.6%
3/17 • Number of events 3 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Nervous system disorders
Tremor
|
17.6%
3/17 • Number of events 3 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
35.3%
6/17 • Number of events 7 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17 • Number of events 2 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Investigations
Weight loss
|
23.5%
4/17 • Number of events 6 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Investigations
White blood cell decreased
|
100.0%
17/17 • Number of events 332 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Infections and infestations
Infections and infestations
|
11.8%
2/17 • Number of events 3 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
|
Investigations
Investigations
|
11.8%
2/17 • Number of events 8 • Start: at initiation of first study procedure (baseline PET/CT imaging) Ends: 30 days after last day of chemoradiation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place