Trial Outcomes & Findings for Evaluate Safety and Tolerability in Dose Escalation of Sorafenib in Advanced Renal Cell Cancer (NCT NCT01189370)
NCT ID: NCT01189370
Last Updated: 2017-06-01
Results Overview
Tolerability will be defined as successful completion of the dose level without experiencing Grade 3 or 4 toxicity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-06-01
Participant Flow
Participant milestones
| Measure |
Cohort 1: 400mg
Participants were administered 400 mg of Sorafenib by mouth twice daily for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
|
Cohort 2: 600 mg
Participants were administered 600mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
|
Cohort 3: 800mg
Participants were administered 800mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
|
|---|---|---|---|
|
Dose Level 1
STARTED
|
25
|
0
|
0
|
|
Dose Level 1
COMPLETED
|
16
|
0
|
0
|
|
Dose Level 1
NOT COMPLETED
|
9
|
0
|
0
|
|
Dose Level 2
STARTED
|
0
|
16
|
0
|
|
Dose Level 2
COMPLETED
|
0
|
12
|
0
|
|
Dose Level 2
NOT COMPLETED
|
0
|
4
|
0
|
|
Dose Level 3
STARTED
|
0
|
0
|
12
|
|
Dose Level 3
COMPLETED
|
0
|
0
|
6
|
|
Dose Level 3
NOT COMPLETED
|
0
|
0
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate Safety and Tolerability in Dose Escalation of Sorafenib in Advanced Renal Cell Cancer
Baseline characteristics by cohort
| Measure |
Sorafenib
n=25 Participants
* Sorafenib 400 mg twice daily, 7 days a week
* Sorafenib 600 mg twice daily, days 1-5 per week
* Sorafenib 800 mg twice daily, days 1-5 per week
* Sorafenib 1000 mg twice daily, says 1-5 per week
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksTolerability will be defined as successful completion of the dose level without experiencing Grade 3 or 4 toxicity.
Outcome measures
| Measure |
Cohort 1: 400mg
n=25 Participants
Participants were administered 400 mg of Sorafenib by mouth twice daily for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
|
Cohort 2: 600 mg
n=16 Participants
Participants were administered 600mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
|
Cohort 3: 800mg
n=12 Participants
Participants were administered 800mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
|
|---|---|---|---|
|
Number of Participants Who Could Tolerate Each Dose Level
Started Dose Level
|
25 Participants
|
16 Participants
|
12 Participants
|
|
Number of Participants Who Could Tolerate Each Dose Level
Completed Dose Level
|
16 Participants
|
12 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 26 monthsDisease Progression as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Outcome measures
| Measure |
Cohort 1: 400mg
n=25 Participants
Participants were administered 400 mg of Sorafenib by mouth twice daily for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
|
Cohort 2: 600 mg
Participants were administered 600mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
|
Cohort 3: 800mg
Participants were administered 800mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
|
|---|---|---|---|
|
Overall Number of Participants That Had Disease Progression on Study
|
17 Participants
|
—
|
—
|
Adverse Events
Sorafenib
Serious events: 14 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib
n=25 participants at risk
* Sorafenib 400 mg twice daily, 7 days a week
* Sorafenib 600 mg twice daily, days 1-5 per week
* Sorafenib 800 mg twice daily, days 1-5 per week
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Disease progression
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.0%
2/25 • Number of events 2
|
|
Injury, poisoning and procedural complications
Intra-operative injury - Joint
|
4.0%
1/25 • Number of events 1
|
|
Injury, poisoning and procedural complications
Intraoperative musculoskeletal injury
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Pain
|
4.0%
1/25 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Syncope
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Treatment related secondary malignancy
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • Number of events 1
|
Other adverse events
| Measure |
Sorafenib
n=25 participants at risk
* Sorafenib 400 mg twice daily, 7 days a week
* Sorafenib 600 mg twice daily, days 1-5 per week
* Sorafenib 800 mg twice daily, days 1-5 per week
|
|---|---|
|
Gastrointestinal disorders
Abdominal distention
|
12.0%
3/25 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
28.0%
7/25 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Acne
|
28.0%
7/25 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.0%
10/25 • Number of events 10
|
|
Gastrointestinal disorders
Anorexia
|
56.0%
14/25 • Number of events 23
|
|
Psychiatric disorders
Anxiety
|
4.0%
1/25 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
24.0%
6/25 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Bruising
|
8.0%
2/25 • Number of events 2
|
|
Cardiac disorders
Chest pain
|
12.0%
3/25 • Number of events 3
|
|
Gastrointestinal disorders
constipation
|
52.0%
13/25 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
12.0%
3/25 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
decubitus
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
dehydration
|
4.0%
1/25 • Number of events 1
|
|
Psychiatric disorders
Depression
|
8.0%
2/25 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify)
|
36.0%
9/25 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhea
|
72.0%
18/25 • Number of events 39
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
dry mouth
|
8.0%
2/25 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
24.0%
6/25 • Number of events 7
|
|
Gastrointestinal disorders
Dyspepsia
|
8.0%
2/25 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia
|
4.0%
1/25 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
36.0%
9/25 • Number of events 12
|
|
Ear and labyrinth disorders
Ear, nose and throat examination abnormal
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Edema limbs
|
20.0%
5/25 • Number of events 8
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
8.0%
2/25 • Number of events 2
|
|
Blood and lymphatic system disorders
Edema: trunk/genital
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Esophogeal mucositis
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Esophagitis
|
4.0%
1/25 • Number of events 1
|
|
Ear and labyrinth disorders
Pain: external ear
|
4.0%
1/25 • Number of events 1
|
|
General disorders
fatigue
|
76.0%
19/25 • Number of events 33
|
|
General disorders
fever
|
4.0%
1/25 • Number of events 1
|
|
Vascular disorders
Flushing
|
12.0%
3/25 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
fracture
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Gingival infection
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Gingival pain
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Hand and foot syndrome
|
60.0%
15/25 • Number of events 31
|
|
Nervous system disorders
headache
|
12.0%
3/25 • Number of events 4
|
|
Ear and labyrinth disorders
Hearing (without monitoring program)
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
20.0%
5/25 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
12.0%
3/25 • Number of events 4
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
12.0%
3/25 • Number of events 5
|
|
Vascular disorders
Hypertension
|
4.0%
1/25 • Number of events 1
|
|
Vascular disorders
Hypotension
|
8.0%
2/25 • Number of events 2
|
|
Infections and infestations
Infection
|
12.0%
3/25 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
20.0%
5/25 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
joint-function
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Lipase increased
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
28.0%
7/25 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
20.0%
5/25 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal - Other (Specify)
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.0%
3/25 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
68.0%
17/25 • Number of events 22
|
|
Blood and lymphatic system disorders
Neutrophils
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
20.0%
5/25 • Number of events 5
|
|
Ear and labyrinth disorders
Otitis, external
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Pain - Other
|
8.0%
2/25 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
36.0%
9/25 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Pain: skin
|
4.0%
1/25 • Number of events 1
|
|
Reproductive system and breast disorders
Pain: pelvic
|
4.0%
1/25 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Pharyngolaryngeal pain
|
8.0%
2/25 • Number of events 3
|
|
Investigations
Platelets
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
16.0%
4/25 • Number of events 5
|
|
Psychiatric disorders
Psychosis
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other(specify)
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
40.0%
10/25 • Number of events 16
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
4.0%
1/25 • Number of events 3
|
|
Renal and urinary disorders
Renal failure
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Rigors/chills
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain: scalp
|
8.0%
2/25 • Number of events 2
|
|
Cardiac disorders
Sinus tachycardia
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Skin infection
|
8.0%
2/25 • Number of events 2
|
|
Nervous system disorders
Speech impairment
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Pain: stomach
|
8.0%
2/25 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Sweating
|
12.0%
3/25 • Number of events 4
|
|
Gastrointestinal disorders
Taste alteration
|
24.0%
6/25 • Number of events 8
|
|
Vascular disorders
Thrombosis
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Tooth disorder
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
toothache
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Upper aerodigestive tract infection
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
4.0%
1/25 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
4.0%
1/25 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal discharge
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Vaginal infection
|
4.0%
1/25 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginitis
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Valvular heart disease
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
10/25 • Number of events 12
|
|
Investigations
Weight gain
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Weight loss
|
20.0%
5/25 • Number of events 5
|
Additional Information
Dr. Peter Van Velduizen
University of Kansas Cancer Center
Phone: 913-945-5059
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place