Trial Outcomes & Findings for Phase II Study of RAD001 Head and Neck Cancer (NCT NCT01051791)
NCT ID: NCT01051791
Last Updated: 2017-12-19
Results Overview
The number of patients with recurrent/refractory SCCHN (head and neck squamous cell carcinoma) treated with single-agent everolimus that, experience a Complete Response (CR) + number of patients that experience a Partial Response (PR ) + number of patients that experience Stable Disease (SD) / total evaluable patients.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Up to 60 months
Results posted on
2017-12-19
Participant Flow
Participant milestones
| Measure |
Everolimus 10 mg Daily
Patients with a planned treatment of continuous 28-day cycles of everolimus 10 mg by mouth daily.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Everolimus 10 mg Daily
Patients with a planned treatment of continuous 28-day cycles of everolimus 10 mg by mouth daily.
|
|---|---|
|
Overall Study
Failed screening
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Phase II Study of RAD001 Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Everolimus 10 mg Daily
n=9 Participants
Patients with a planned treatment of continuous 28-day cycles of everolimus 10 mg by mouth daily.
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 60 monthsPopulation: Patients that completed at least 1 cycle of everolimus treatment.
The number of patients with recurrent/refractory SCCHN (head and neck squamous cell carcinoma) treated with single-agent everolimus that, experience a Complete Response (CR) + number of patients that experience a Partial Response (PR ) + number of patients that experience Stable Disease (SD) / total evaluable patients.
Outcome measures
| Measure |
Everolimus 10 mg Daily
n=7 Participants
Patients that completed at least 1 cycle of everolimus everolimus 10 mg by mouth daily. Response to treatment was evaluated by cross-sectional imaging every 8 weeks or as clinically indicated, starting at the end of cycle 2 and continuing until determination of progressive disease.
|
|---|---|
|
Clinical Benefit Rate (CBR)
|
28 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 60 monthsOutcome measures
| Measure |
Everolimus 10 mg Daily
n=9 Participants
Patients that completed at least 1 cycle of everolimus everolimus 10 mg by mouth daily. Response to treatment was evaluated by cross-sectional imaging every 8 weeks or as clinically indicated, starting at the end of cycle 2 and continuing until determination of progressive disease.
|
|---|---|
|
Progression Free Survival (PFS)
|
1.5 months
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: Up to 60 monthsOutcome measures
| Measure |
Everolimus 10 mg Daily
n=9 Participants
Patients that completed at least 1 cycle of everolimus everolimus 10 mg by mouth daily. Response to treatment was evaluated by cross-sectional imaging every 8 weeks or as clinically indicated, starting at the end of cycle 2 and continuing until determination of progressive disease.
|
|---|---|
|
Overall Survival (OS)
|
4.5 months
Interval 3.0 to 24.0
|
SECONDARY outcome
Timeframe: Up to 60 monthsPopulation: Patients that completed at least 1 cycle of everolimus treatment. Response to treatment was evaluated by cross-sectional imaging every 8 weeks or as clinically indicated, starting at the end of cycle 2 and continuing until determination of progressive disease.
The number of patients with recurrent/refractory SCCHN (head and neck squamous cell carcinoma) treated with single-agent everolimus that, experience a Complete Response (CR) + number of patients that experience a Partial Response (PR ) / total evaluable patients.
Outcome measures
| Measure |
Everolimus 10 mg Daily
n=7 Participants
Patients that completed at least 1 cycle of everolimus everolimus 10 mg by mouth daily. Response to treatment was evaluated by cross-sectional imaging every 8 weeks or as clinically indicated, starting at the end of cycle 2 and continuing until determination of progressive disease.
|
|---|---|
|
Objective Response Rate (ORR)
|
0 percentage of participants
|
Adverse Events
Everolimus 10 mg Daily
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Everolimus 10 mg Daily
n=9 participants at risk
Patients with any treatment of everolimus 10 mg by mouth daily.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
77.8%
7/9
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
33.3%
3/9
|
|
Blood and lymphatic system disorders
Lymphopenia
|
55.6%
5/9
|
|
Blood and lymphatic system disorders
Platelets
|
33.3%
3/9
|
|
Cardiac disorders
Hypotension
|
11.1%
1/9
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
55.6%
5/9
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
22.2%
2/9
|
|
General disorders
Odor (patient odor)
|
11.1%
1/9
|
|
General disorders
Rigors/chills
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
22.2%
2/9
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
22.2%
2/9
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
33.3%
3/9
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
22.2%
2/9
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
22.2%
2/9
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
22.2%
2/9
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
22.2%
2/9
|
|
Gastrointestinal disorders
Anorexia
|
11.1%
1/9
|
|
Gastrointestinal disorders
Constipation
|
33.3%
3/9
|
|
Gastrointestinal disorders
Dehydration
|
11.1%
1/9
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
22.2%
2/9
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
55.6%
5/9
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic), Oral cavity
|
33.3%
3/9
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9
|
|
Gastrointestinal disorders
Salivary gland changes/saliva
|
11.1%
1/9
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9
|
|
Infections and infestations
Infection - Other (Specify, __)
|
22.2%
2/9
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
44.4%
4/9
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
33.3%
3/9
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
55.6%
5/9
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
66.7%
6/9
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
22.2%
2/9
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
22.2%
2/9
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
11.1%
1/9
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
77.8%
7/9
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
11.1%
1/9
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
11.1%
1/9
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
44.4%
4/9
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
33.3%
3/9
|
|
Musculoskeletal and connective tissue disorders
Fibrosis-deep connective tissue
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy), Facial
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Trismus (difficulty, restriction or pain when opening mouth)
|
11.1%
1/9
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9
|
|
Nervous system disorders
Neuropathy: cranial, CN IX Motor-pharynx; Sensory-ear, pharynx, tongue
|
11.1%
1/9
|
|
General disorders
Pain - Other (Specify, __)
|
33.3%
3/9
|
|
General disorders
Pain, Abdomen NOS
|
22.2%
2/9
|
|
General disorders
Pain, External ear
|
11.1%
1/9
|
|
General disorders
Pain, Extremity-limb
|
22.2%
2/9
|
|
General disorders
Pain, Eye
|
11.1%
1/9
|
|
General disorders
Pain, Face
|
22.2%
2/9
|
|
General disorders
Pain, Head/headache
|
33.3%
3/9
|
|
General disorders
Pain, Joint
|
11.1%
1/9
|
|
General disorders
Pain, Middle ear
|
11.1%
1/9
|
|
General disorders
Pain, Oral cavity
|
22.2%
2/9
|
|
General disorders
Pain, Throat/pharynx/larynx
|
22.2%
2/9
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
22.2%
2/9
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
2/9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction/stenosis of airway, Trachea
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
11.1%
1/9
|
Additional Information
Barbara Stadterman, Regulatory Supervisor
University of Pittsburgh Cancer Institute
Phone: 412-647-5554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place