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Axitinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT01533948
Recruitment Status : Terminated (low accrual)
First Posted : February 16, 2012
Results First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Extraocular Extension Melanoma
Metastatic Intraocular Melanoma
Recurrent Intraocular Melanoma
Recurrent Melanoma
Stage IIIA Intraocular Melanoma
Stage IIIA Melanoma
Stage IIIB Intraocular Melanoma
Stage IIIB Melanoma
Stage IIIC Intraocular Melanoma
Stage IIIC Melanoma
Stage IV Intraocular Melanoma
Stage IV Melanoma
Interventions Drug: axitinib
Other: laboratory biomarker analysis
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Axitinib)
Hide Arm/Group Description

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
Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title Treatment (Axitinib)
Hide Arm/Group Description

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 Number of Baseline Participants 25
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
  40.0%
>=65 years
15
  60.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
68.8  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
11
  44.0%
Male
14
  56.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
25
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Overall Response Rate (Complete Response + Partial Response) to Axitinib as Assessed Using RECIST Version 1.1
Hide Description 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.
Time Frame Up to 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Treatment (Axitinib)
Hide Arm/Group Description:

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 Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12
(3 to 31)
2.Secondary Outcome
Title Number of Patients That Experienced at Least One Grade 3 Adverse Event
Hide Description 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.
Time Frame Up to 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Treatment (Axitinib)
Hide Arm/Group Description:

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 Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
12
  48.0%
3.Secondary Outcome
Title Median Progression-free Survival (PFS)
Hide Description 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
Time Frame From the date of study enrollment to the first observation of progressive disease or death within 30 days after last dose of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Treatment (Axitinib)
Hide Arm/Group Description:

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 Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: months
2.1
(1.8 to 4.5)
4.Secondary Outcome
Title Median Overall Survival (OS)
Hide Description The distribution will be described using Kaplan-Meier and proportional hazards methods.
Time Frame From the date of study enrollment to the time of death within 30 days after last dose of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Treatment (Axitinib)
Hide Arm/Group Description:

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 Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: months
7.4
(5.5 to 18.3)
5.Secondary Outcome
Title The Baseline Circulative Tumor Cells Value of Responders
Hide Description 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.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients that responded
Arm/Group Title Treatment (Axitinib)
Hide Arm/Group Description:

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 Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
0  (0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Axitinib)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Axitinib)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Axitinib)
Affected / at Risk (%) # Events
Total   8/25 (32.00%)    
Blood and lymphatic system disorders   
Anaemia   1/25 (4.00%)  1
Cardiac disorders   
Atrial fibrillation   1/25 (4.00%)  19
Gastrointestinal disorders   
Abdominal pain   2/25 (8.00%)  3
Ascites   1/25 (4.00%)  6
Diarrhoea   1/25 (4.00%)  1
Pancreatitis   1/25 (4.00%)  8
Small intestinal perforation   1/25 (4.00%)  6
General disorders   
Death   1/25 (4.00%)  13
Infections and infestations   
Sepsis   1/25 (4.00%)  17
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasm malignant   1/25 (4.00%)  28
Nervous system disorders   
Haemorrhage intracranial   1/25 (4.00%)  37
Psychiatric disorders   
Confusional state   2/25 (8.00%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Axitinib)
Affected / at Risk (%) # Events
Total   25/25 (100.00%)    
Blood and lymphatic system disorders   
Anaemia   1/25 (4.00%)  22
Lymph node pain   1/25 (4.00%)  2
Endocrine disorders   
Hyperthyroidism   1/25 (4.00%)  17
Hypothyroidism   9/25 (36.00%)  13
Gastrointestinal disorders   
Abdominal distension   1/25 (4.00%)  24
Abdominal pain   5/25 (20.00%)  29
Abdominal pain lower   1/25 (4.00%)  7
Abdominal pain upper   1/25 (4.00%)  35
Constipation   4/25 (16.00%)  9
Dental caries   1/25 (4.00%)  14
Diarrhoea   10/25 (40.00%)  54
Dry mouth   2/25 (8.00%)  13
Dyspepsia   2/25 (8.00%)  31
Flatulence   1/25 (4.00%)  18
Gastrooesophageal reflux disease   2/25 (8.00%)  16
Nausea   5/25 (20.00%)  11
Oesophageal pain   1/25 (4.00%)  7
Paraesthesia oral   3/25 (12.00%)  27
Stomatitis   8/25 (32.00%)  19
Vomiting   2/25 (8.00%)  20
General disorders   
Asthenia   1/25 (4.00%)  22
Fatigue   15/25 (60.00%)  26
Mucosal inflammation   1/25 (4.00%)  1
Non-cardiac chest pain   2/25 (8.00%)  2
Oedema peripheral   1/25 (4.00%)  78
Infections and infestations   
Bacteraemia   1/25 (4.00%)  10
Gastrointestinal infection   1/25 (4.00%)  5
Infusion site infection   1/25 (4.00%)  1
Nasopharyngitis   1/25 (4.00%)  15
Sinusitis   1/25 (4.00%)  8
Tooth infection   2/25 (8.00%)  2
Injury, poisoning and procedural complications   
Fall   1/25 (4.00%)  4
Limb injury   1/25 (4.00%)  14
Investigations   
Alanine aminotransferase increased   3/25 (12.00%)  15
Aspartate aminotransferase increased   9/25 (36.00%)  14
Blood alkaline phosphatase increased   2/25 (8.00%)  19
Blood thyroid stimulating hormone increased   1/25 (4.00%)  12
Haemoglobin decreased   1/25 (4.00%)  10
Lymphocyte count decreased   6/25 (24.00%)  16
Platelet count decreased   1/25 (4.00%)  6
Weight decreased   6/25 (24.00%)  13
Metabolism and nutrition disorders   
Cachexia   1/25 (4.00%)  6
Decreased appetite   7/25 (28.00%)  13
Hypercalcaemia   1/25 (4.00%)  5
Hyperkalaemia   2/25 (8.00%)  4
Hypernatraemia   2/25 (8.00%)  4
Hyponatraemia   1/25 (4.00%)  10
Vitamin B12 deficiency   1/25 (4.00%)  4
Musculoskeletal and connective tissue disorders   
Arthralgia   4/25 (16.00%)  57
Back pain   2/25 (8.00%)  32
Muscular weakness   1/25 (4.00%)  22
Musculoskeletal chest pain   3/25 (12.00%)  8
Musculoskeletal pain   2/25 (8.00%)  18
Myalgia   2/25 (8.00%)  18
Nervous system disorders   
Dizziness   1/25 (4.00%)  17
Dysgeusia   5/25 (20.00%)  21
Headache   5/25 (20.00%)  37
Neuralgia   1/25 (4.00%)  8
Sinus headache   1/25 (4.00%)  4
Psychiatric disorders   
Anxiety   4/25 (16.00%)  30
Confusional state   1/25 (4.00%)  15
Depression   2/25 (8.00%)  31
Insomnia   2/25 (8.00%)  17
Renal and urinary disorders   
Haematuria   1/25 (4.00%)  16
Nocturia   1/25 (4.00%)  5
Proteinuria   2/25 (8.00%)  4
Renal failure acute   1/25 (4.00%)  28
Respiratory, thoracic and mediastinal disorders   
Cough   4/25 (16.00%)  20
Dysphonia   14/25 (56.00%)  18
Dyspnoea   2/25 (8.00%)  31
Hiccups   1/25 (4.00%)  7
Pleural effusion   1/25 (4.00%)  9
Pulmonary embolism   1/25 (4.00%)  14
Upper-airway cough syndrome   2/25 (8.00%)  4
Skin and subcutaneous tissue disorders   
Alopecia   1/25 (4.00%)  13
Dermatitis acneiform   1/25 (4.00%)  6
Dry skin   3/25 (12.00%)  11
Erythema   1/25 (4.00%)  32
Nail disorder   1/25 (4.00%)  11
Palmar-plantar erythrodysaesthesia syndrome   10/25 (40.00%)  18
Rash   2/25 (8.00%)  36
Rash erythematous   1/25 (4.00%)  9
Skin ulcer   1/25 (4.00%)  38
Vascular disorders   
Hypertension   10/25 (40.00%)  35
Hypotension   3/25 (12.00%)  24
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01533948     History of Changes
Other Study ID Numbers: I 197811
NCI-2011-03037 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 197811 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Submitted: January 18, 2012
First Posted: February 16, 2012
Results First Submitted: January 9, 2018
Results First Posted: May 9, 2018
Last Update Posted: May 9, 2018