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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Treatment (Axitinib)
STARTED   25 
COMPLETED   25 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All treated and eligible patients

Reporting Groups
  Description
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

Baseline Measures
   Treatment (Axitinib) 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      10  40.0% 
>=65 years      15  60.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.8  (11.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11  44.0% 
Male      14  56.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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% 


  Outcome Measures

1.  Primary:   Overall Response Rate (Complete Response + Partial Response) to Axitinib as Assessed Using RECIST Version 1.1   [ Time Frame: Up to 30 days ]

2.  Secondary:   Number of Patients That Experienced at Least One Grade 3 Adverse Event   [ Time Frame: Up to 30 days ]

3.  Secondary:   Median Progression-free Survival (PFS)   [ 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 ]

4.  Secondary:   Median Overall Survival (OS)   [ Time Frame: From the date of study enrollment to the time of death within 30 days after last dose of study drug ]

5.  Secondary:   The Baseline Circulative Tumor Cells Value of Responders   [ Time Frame: Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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