Trial Outcomes & Findings for Axitinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed by Surgery (NCT NCT01533948)
NCT ID: NCT01533948
Last Updated: 2018-05-09
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to 30 days
Results posted on
2018-05-09
Participant Flow
Participant milestones
| Measure |
Treatment (Axitinib)
Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
axitinib: Given PO
The starting dose for axitinib is 5 mg taken orally twice daily with food. Axitinib will be taken beginning on Day 1 of the study and taken approximately 12 hours apart continuous dosing.
Dose Level Dose Dispensed As
* 2: 10 mg PO BID 2 X 5 mg tablets BID
* 1: 7 mg PO BID 1 X 5 mg tablet BID + 2 X 1 mg tablets BID 0: (Starting Dose) 5 mg PO BID 1 X 5 mg tablet BID
* 1: 3 mg PO BID 3 X 1 mg tablets BID
* 2: 2 mg PO BID 2 X 1 mg tablets BID
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Axitinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Treatment (Axitinib)
n=25 Participants
Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
axitinib: Given PO
The starting dose for axitinib is 5 mg taken orally twice daily with food. Axitinib will be taken beginning on Day 1 of the study and taken approximately 12 hours apart continuous dosing.
Dose Level Dose Dispensed As
* 2: 10 mg PO BID 2 X 5 mg tablets BID
* 1: 7 mg PO BID 1 X 5 mg tablet BID + 2 X 1 mg tablets BID 0: (Starting Dose) 5 mg PO BID 1 X 5 mg tablet BID
* 1: 3 mg PO BID 3 X 1 mg tablets BID
* 2: 2 mg PO BID 2 X 1 mg tablets BID
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 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
|
PRIMARY outcome
Timeframe: Up to 30 daysPopulation: All treated and eligible patients
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Axitinib)
n=25 Participants
Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
axitinib: Given PO
The starting dose for axitinib is 5 mg taken orally twice daily with food. Axitinib will be taken beginning on Day 1 of the study and taken approximately 12 hours apart continuous dosing.
Dose Level Dose Dispensed As
* 2: 10 mg PO BID 2 X 5 mg tablets BID
* 1: 7 mg PO BID 1 X 5 mg tablet BID + 2 X 1 mg tablets BID 0: (Starting Dose) 5 mg PO BID 1 X 5 mg tablet BID
* 1: 3 mg PO BID 3 X 1 mg tablets BID
* 2: 2 mg PO BID 2 X 1 mg tablets BID
|
|---|---|
|
Overall Response Rate (Complete Response + Partial Response) to Axitinib as Assessed Using RECIST Version 1.1
|
12 percentage of participants
Interval 3.0 to 31.0
|
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: All treated and eligible patients
Number of patients that experienced at least one grade 3 toxicity regardless of attribution. Incidence of toxicity of axitinib as a single agent as assessed by the severity of adverse effects by NCI CTCAE version 4. Please refer to the adverse event reporting for more detail.
Outcome measures
| Measure |
Treatment (Axitinib)
n=25 Participants
Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
axitinib: Given PO
The starting dose for axitinib is 5 mg taken orally twice daily with food. Axitinib will be taken beginning on Day 1 of the study and taken approximately 12 hours apart continuous dosing.
Dose Level Dose Dispensed As
* 2: 10 mg PO BID 2 X 5 mg tablets BID
* 1: 7 mg PO BID 1 X 5 mg tablet BID + 2 X 1 mg tablets BID 0: (Starting Dose) 5 mg PO BID 1 X 5 mg tablet BID
* 1: 3 mg PO BID 3 X 1 mg tablets BID
* 2: 2 mg PO BID 2 X 1 mg tablets BID
|
|---|---|
|
Number of Patients That Experienced at Least One Grade 3 Adverse Event
|
12 Participants
|
SECONDARY outcome
Timeframe: From the date of study enrollment to the first observation of progressive disease or death within 30 days after last dose of study drugPopulation: All treated and eligible patients
The distribution will be described using Kaplan-Meier and proportional hazards methods. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Treatment (Axitinib)
n=25 Participants
Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
axitinib: Given PO
The starting dose for axitinib is 5 mg taken orally twice daily with food. Axitinib will be taken beginning on Day 1 of the study and taken approximately 12 hours apart continuous dosing.
Dose Level Dose Dispensed As
* 2: 10 mg PO BID 2 X 5 mg tablets BID
* 1: 7 mg PO BID 1 X 5 mg tablet BID + 2 X 1 mg tablets BID 0: (Starting Dose) 5 mg PO BID 1 X 5 mg tablet BID
* 1: 3 mg PO BID 3 X 1 mg tablets BID
* 2: 2 mg PO BID 2 X 1 mg tablets BID
|
|---|---|
|
Median Progression-free Survival (PFS)
|
2.1 months
Interval 1.8 to 4.5
|
SECONDARY outcome
Timeframe: From the date of study enrollment to the time of death within 30 days after last dose of study drugPopulation: All treated and eligible patients
The distribution will be described using Kaplan-Meier and proportional hazards methods.
Outcome measures
| Measure |
Treatment (Axitinib)
n=25 Participants
Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
axitinib: Given PO
The starting dose for axitinib is 5 mg taken orally twice daily with food. Axitinib will be taken beginning on Day 1 of the study and taken approximately 12 hours apart continuous dosing.
Dose Level Dose Dispensed As
* 2: 10 mg PO BID 2 X 5 mg tablets BID
* 1: 7 mg PO BID 1 X 5 mg tablet BID + 2 X 1 mg tablets BID 0: (Starting Dose) 5 mg PO BID 1 X 5 mg tablet BID
* 1: 3 mg PO BID 3 X 1 mg tablets BID
* 2: 2 mg PO BID 2 X 1 mg tablets BID
|
|---|---|
|
Median Overall Survival (OS)
|
7.4 months
Interval 5.5 to 18.3
|
SECONDARY outcome
Timeframe: BaselinePopulation: All treated and eligible patients that responded
The baseline Circulative tumor Cells values of patients with response to treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. CTC were evaluated at baseline, response was assessed up to 30 days.
Outcome measures
| Measure |
Treatment (Axitinib)
n=3 Participants
Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
axitinib: Given PO
The starting dose for axitinib is 5 mg taken orally twice daily with food. Axitinib will be taken beginning on Day 1 of the study and taken approximately 12 hours apart continuous dosing.
Dose Level Dose Dispensed As
* 2: 10 mg PO BID 2 X 5 mg tablets BID
* 1: 7 mg PO BID 1 X 5 mg tablet BID + 2 X 1 mg tablets BID 0: (Starting Dose) 5 mg PO BID 1 X 5 mg tablet BID
* 1: 3 mg PO BID 3 X 1 mg tablets BID
* 2: 2 mg PO BID 2 X 1 mg tablets BID
|
|---|---|
|
The Baseline Circulative Tumor Cells Value of Responders
|
0 cells/mm^3
Standard Deviation 0
|
Adverse Events
Treatment (Axitinib)
Serious events: 8 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Axitinib)
n=25 participants at risk
Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
axitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
1/25 • Number of events 19
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
2/25 • Number of events 3
|
|
Gastrointestinal disorders
Ascites
|
4.0%
1/25 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
4.0%
1/25 • Number of events 8
|
|
Gastrointestinal disorders
Small intestinal perforation
|
4.0%
1/25 • Number of events 6
|
|
General disorders
Death
|
4.0%
1/25 • Number of events 13
|
|
Infections and infestations
Sepsis
|
4.0%
1/25 • Number of events 17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
4.0%
1/25 • Number of events 28
|
|
Nervous system disorders
Haemorrhage intracranial
|
4.0%
1/25 • Number of events 37
|
|
Psychiatric disorders
Confusional state
|
8.0%
2/25 • Number of events 2
|
Other adverse events
| Measure |
Treatment (Axitinib)
n=25 participants at risk
Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
axitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
1/25 • Number of events 22
|
|
Blood and lymphatic system disorders
Lymph node pain
|
4.0%
1/25 • Number of events 2
|
|
Endocrine disorders
Hyperthyroidism
|
4.0%
1/25 • Number of events 17
|
|
Endocrine disorders
Hypothyroidism
|
36.0%
9/25 • Number of events 13
|
|
Gastrointestinal disorders
Abdominal distension
|
4.0%
1/25 • Number of events 24
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
5/25 • Number of events 29
|
|
Gastrointestinal disorders
Abdominal pain lower
|
4.0%
1/25 • Number of events 7
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.0%
1/25 • Number of events 35
|
|
Gastrointestinal disorders
Constipation
|
16.0%
4/25 • Number of events 9
|
|
Gastrointestinal disorders
Dental caries
|
4.0%
1/25 • Number of events 14
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
10/25 • Number of events 54
|
|
Gastrointestinal disorders
Dry mouth
|
8.0%
2/25 • Number of events 13
|
|
Gastrointestinal disorders
Dyspepsia
|
8.0%
2/25 • Number of events 31
|
|
Gastrointestinal disorders
Flatulence
|
4.0%
1/25 • Number of events 18
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.0%
2/25 • Number of events 16
|
|
Gastrointestinal disorders
Nausea
|
20.0%
5/25 • Number of events 11
|
|
Gastrointestinal disorders
Oesophageal pain
|
4.0%
1/25 • Number of events 7
|
|
Gastrointestinal disorders
Paraesthesia oral
|
12.0%
3/25 • Number of events 27
|
|
Gastrointestinal disorders
Stomatitis
|
32.0%
8/25 • Number of events 19
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • Number of events 20
|
|
General disorders
Asthenia
|
4.0%
1/25 • Number of events 22
|
|
General disorders
Fatigue
|
60.0%
15/25 • Number of events 26
|
|
General disorders
Mucosal inflammation
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Oedema peripheral
|
4.0%
1/25 • Number of events 78
|
|
Infections and infestations
Bacteraemia
|
4.0%
1/25 • Number of events 10
|
|
Infections and infestations
Gastrointestinal infection
|
4.0%
1/25 • Number of events 5
|
|
Infections and infestations
Infusion site infection
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
1/25 • Number of events 15
|
|
Infections and infestations
Sinusitis
|
4.0%
1/25 • Number of events 8
|
|
Infections and infestations
Tooth infection
|
8.0%
2/25 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
1/25 • Number of events 4
|
|
Injury, poisoning and procedural complications
Limb injury
|
4.0%
1/25 • Number of events 14
|
|
Investigations
Alanine aminotransferase increased
|
12.0%
3/25 • Number of events 15
|
|
Investigations
Aspartate aminotransferase increased
|
36.0%
9/25 • Number of events 14
|
|
Investigations
Blood alkaline phosphatase increased
|
8.0%
2/25 • Number of events 19
|
|
Investigations
Blood thyroid stimulating hormone increased
|
4.0%
1/25 • Number of events 12
|
|
Investigations
Haemoglobin decreased
|
4.0%
1/25 • Number of events 10
|
|
Investigations
Lymphocyte count decreased
|
24.0%
6/25 • Number of events 16
|
|
Investigations
Platelet count decreased
|
4.0%
1/25 • Number of events 6
|
|
Investigations
Weight decreased
|
24.0%
6/25 • Number of events 13
|
|
Metabolism and nutrition disorders
Cachexia
|
4.0%
1/25 • Number of events 6
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.0%
7/25 • Number of events 13
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
4.0%
1/25 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.0%
2/25 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
8.0%
2/25 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.0%
1/25 • Number of events 10
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
4.0%
1/25 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.0%
4/25 • Number of events 57
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25 • Number of events 32
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.0%
1/25 • Number of events 22
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
12.0%
3/25 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.0%
2/25 • Number of events 18
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.0%
2/25 • Number of events 18
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • Number of events 17
|
|
Nervous system disorders
Dysgeusia
|
20.0%
5/25 • Number of events 21
|
|
Nervous system disorders
Headache
|
20.0%
5/25 • Number of events 37
|
|
Nervous system disorders
Neuralgia
|
4.0%
1/25 • Number of events 8
|
|
Nervous system disorders
Sinus headache
|
4.0%
1/25 • Number of events 4
|
|
Psychiatric disorders
Anxiety
|
16.0%
4/25 • Number of events 30
|
|
Psychiatric disorders
Confusional state
|
4.0%
1/25 • Number of events 15
|
|
Psychiatric disorders
Depression
|
8.0%
2/25 • Number of events 31
|
|
Psychiatric disorders
Insomnia
|
8.0%
2/25 • Number of events 17
|
|
Renal and urinary disorders
Haematuria
|
4.0%
1/25 • Number of events 16
|
|
Renal and urinary disorders
Nocturia
|
4.0%
1/25 • Number of events 5
|
|
Renal and urinary disorders
Proteinuria
|
8.0%
2/25 • Number of events 4
|
|
Renal and urinary disorders
Renal failure acute
|
4.0%
1/25 • Number of events 28
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.0%
4/25 • Number of events 20
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
56.0%
14/25 • Number of events 18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.0%
2/25 • Number of events 31
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.0%
1/25 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
1/25 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.0%
1/25 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
8.0%
2/25 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
1/25 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
4.0%
1/25 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.0%
3/25 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.0%
1/25 • Number of events 32
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
4.0%
1/25 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
40.0%
10/25 • Number of events 18
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.0%
2/25 • Number of events 36
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
4.0%
1/25 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
4.0%
1/25 • Number of events 38
|
|
Vascular disorders
Hypertension
|
40.0%
10/25 • Number of events 35
|
|
Vascular disorders
Hypotension
|
12.0%
3/25 • Number of events 24
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place