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NEXT: Subsequent Exposure to Tyrosine Kinase Inhibition at Recurrence After Adjuvant Therapy in Renal Cell Carcinoma (PrE0801)

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ClinicalTrials.gov Identifier: NCT01649180
Recruitment Status : Terminated (Closed due to prolonged enrollment timelines)
First Posted : July 25, 2012
Results First Posted : April 20, 2017
Last Update Posted : May 23, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
PrECOG, LLC.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Cell Carcinoma
Intervention Drug: Axitinib
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Axitinib
Hide Arm/Group Description

Axitinib will be given orally and will continue until progression of disease.

Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days.

Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Axitinib
Hide Arm/Group Description

Axitinib will be given orally and will continue until progression of disease.

Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days.

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants
54
(52 to 55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
0
   0.0%
Male
3
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 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
3
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Progression-free Survival
Hide Description Progression-free survival is defined as the time from registration to disease progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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 Assessed every 12 weeks up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
all participants
Arm/Group Title Axitinib
Hide Arm/Group Description:

Axitinib will be given orally and will continue until progression of disease.

Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days.

Overall Number of Participants Analyzed 3
Median (95% Confidence Interval)
Unit of Measure: months
16.6 [1] 
(16.6 to NA)
[1]
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
2.Secondary Outcome
Title Overall Response Rate
Hide Description

Best overall response was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0). Response is defined as complete response or partial response.

Complete Response (CR): disappearance of all target lesions Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions

Time Frame Assessed every 12 weeks up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
all participants
Arm/Group Title Axitinib
Hide Arm/Group Description:

Axitinib will be given orally and will continue until progression of disease.

Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days.

Overall Number of Participants Analyzed 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
1.00
(0.29 to 1.00)
3.Secondary Outcome
Title Biospecimen Banking for IL-8 and VEGF-A
Hide Description

To bank biospecimens for the retrospective determination of whether baseline or changes in cytokine levels of IL-8 and VEGF-A predict response to treatment in this setting. Banking of plasma and serum is optional but strongly encouraged.

Note: The assays to assess cytokine levels of IL-8 and VEGF-A were not performed because the study stopped early and only 3 patients were enrolled. Therefore, the analysis to evaluate the associations between response and IL-8 as well as VEGF-A was not be done.

Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Axitinib
Hide Arm/Group Description:

Axitinib will be given orally and will continue until progression of disease.

Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Biospecimen Banking for SNPs Analysis
Hide Description

To bank biospecimens for the retrospective determination of whether baseline single nucleotide polymorphisms (SNPs) in angiogenesis-related genes predict response to treatment (candidate gene approach). Banking of PBMC is optional but strongly encouraged.

Note: The SNP genotyping analysis was not performed because the study stopped early and only 3 patients were enrolled. Therefore, the analysis to evaluate the association between baseline SNPs in angiogenesis-related genes and response was not be done.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Axitinib
Hide Arm/Group Description:

Axitinib will be given orally and will continue until progression of disease.

Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Tumor Tissue Banking
Hide Description

To bank tumor tissue (formalin-fixed, paraffin-embedded tumor blocks) for retrospective examination of the molecular pathophysiologic mediators of tumorigenesis and progression such as phospho-protein expression of MAPK signaling network intermediates in endothelial cells. Banking of tumor tissue is optional but strongly encouraged.

Note: None of the 3 patients submitted tumor tissues so the analysis won't be performed.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Axitinib
Hide Arm/Group Description:

Axitinib will be given orally and will continue until progression of disease.

Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were assessed while on treatment (up to 26 months) and for 30 days after the last dose of study drug.
Adverse Event Reporting Description Adverse events were routinely assessed by the treating clinician according to the schedule above.
 
Arm/Group Title Axitinib
Hide Arm/Group Description

Axitinib will be given orally and will continue until progression of disease.

Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days.

All-Cause Mortality
Axitinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Axitinib
Affected / at Risk (%) # Events
Total   1/3 (33.33%)    
Eye disorders   
Retinal vascular disorder  1 [1]  1/3 (33.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
retinal vein occlusion
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Axitinib
Affected / at Risk (%) # Events
Total   3/3 (100.00%)    
General disorders   
Fatigue  1  2/3 (66.67%) 
Metabolism and nutrition disorders   
Anorexia  1  1/3 (33.33%) 
Musculoskeletal and connective tissue disorders   
Pain in Extremity  1  1/3 (33.33%) 
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysesthesia syndrome  1  2/3 (66.67%) 
Vascular disorders   
Hypertension  1  3/3 (100.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: PrECOG Statistician
Organization: ECOG-ACRIN Biostatistics Center
Phone: 617-632-3633
EMail: jmanola@jimmy.harvard.edu
Layout table for additonal information
Responsible Party: PrECOG, LLC.
ClinicalTrials.gov Identifier: NCT01649180     History of Changes
Other Study ID Numbers: PrE0801
WS1512227 ( Other Grant/Funding Number: Pfizer )
First Submitted: July 21, 2012
First Posted: July 25, 2012
Results First Submitted: December 6, 2016
Results First Posted: April 20, 2017
Last Update Posted: May 23, 2017