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Trial record 99 of 2710 for:    Neoplasms, Germ Cell and Embryonal | Neuroendocrine Tumors

Pazopanib as Single Agent in Advanced NETs

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ClinicalTrials.gov Identifier: NCT01280201
Recruitment Status : Completed
First Posted : January 20, 2011
Results First Posted : March 4, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Grupo Espanol de Tumores Neuroendocrinos

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced/Metastatic Neuroendocrine Tumors
Intervention Drug: Pazopanib
Enrollment 44
Recruitment Details Between January 2011 and March 2012, a total of 44 patients were enrolled at 9 Spanish sites, belonging to Group for Neuroendocrine Tumors (GETNE).
Pre-assignment Details  
Arm/Group Title Arm of Pazopanib
Hide Arm/Group Description Single arm of pazopanib 800 mg, administered once a day as the only treatment.
Period Title: Overall Study
Started 44
Completed 44
Not Completed 0
Arm/Group Title Arm of Pazopanib
Hide Arm/Group Description Single arm of pazopanib 800 mg, administered once a day as the only treatment.
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants
60
(38 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
20
  45.5%
Male
24
  54.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 44 participants
44
Tumor type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Pancreatic islet cell tumors
18
  40.9%
Gastrointestinal neuroendocrine tumors
15
  34.1%
Pulmonary carcinoid tumors
5
  11.4%
Thymic carcinoid tumors
3
   6.8%
Unknown primary origin tumors
3
   6.8%
Functional tumor status   [1] 
Measure Type: Number
Unit of measure:  Participants
Functional Number Analyzed 44 participants
13
Nonfunctional Number Analyzed 44 participants
31
[1]
Measure Description: Nonfunctional tumors—no specific clinical syndrome is observed; Functional tumors—the tumors' secretions lead to clinical symptoms.
Histologic status of tumor  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Well differentiated
30
  68.2%
Moderately differentiated
3
   6.8%
Poorly differentiated
2
   4.5%
Unknown
9
  20.5%
Ki67 index  
Measure Type: Number
Unit of measure:  Participants
≤2% Number Analyzed 44 participants
6
3%–10% Number Analyzed 44 participants
13
>10% Number Analyzed 44 participants
5
Unknown Number Analyzed 44 participants
20
Previous biologic treatment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Everolimus
11
  25.0%
Multitargeted agent
16
  36.4%
mTOR and multitargeted inhibitor
8
  18.2%
None
9
  20.5%
Previous chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
16
  36.4%
Previous somatostatin analogs  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
35
  79.5%
Concurrent somatostatin analogs  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
30
  68.2%
1.Primary Outcome
Title Clinical Benefit Rate
Hide Description Per Response Evaluation Criteria In Solid Tumor Criteria (RECIST v1.0) for target lesions and assessed by MRI: complete response (CR) considered as dissapereance of all target lesions: partial response (PR), considered as >=30% decrease in the sum of the longest diameter of target lesions, or stable disease (SD) considered as a decrease <30%, after pazopanib was started. Clinical benefit rate (CBR) was defined as the percentage of patients achieving CR, PR or SD.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm of Pazopanib
Hide Arm/Group Description:
Single arm of pazopanib 800 mg, administered once a day as the only treatment.
Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
11
  73.3%
2.Secondary Outcome
Title Number of Patients Who Had an Event (Disease Progression or Death)
Hide Description Per Response Evaluation Criteria In Solid Tumor Criteria (RECIST v1.0) for target lesions and assessed by MRI, considered as the proportion of patietnts whose target lesions have been reported with a >=30% increase in the sum of the longest diameter of target lesions.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm of Pazopanib
Hide Arm/Group Description:
Single arm of pazopanib 800 mg, administered once a day as the only treatment.
Overall Number of Participants Analyzed 40
Measure Type: Count of Participants
Unit of Measure: Participants
35
  87.5%
3.Secondary Outcome
Title Radiological Objective Complete Response Rate
Hide Description Per Response Evaluation Criteria In Solid Tumor Criteria (RECIST v1.0) for target lesions and assessed by MRI, considered as the proportion of patients whose target lessions have dissaperead after treatment.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm of Pazopanib
Hide Arm/Group Description:
Single arm of pazopanib 800 mg, administered once a day as the only treatment.
Overall Number of Participants Analyzed 44
Measure Type: Count of Participants
Unit of Measure: Participants
4
   9.1%
4.Secondary Outcome
Title Duration of Response (DoR)
Hide Description Defined, for the subset of patients with a confirmed CR o PR, as the time from first documented evidence of CR or PR until first documented disease progression or death due to any cause. The DR data will be censored the day after the last evaluation in those patients who did not present an objective tumoral progression and did not died during their participation in the trial. The DR will be assessed only in the subset of patients presenting objective response.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm of Pazopanib
Hide Arm/Group Description:
Single arm of pazopanib 800 mg, administered once a day as the only treatment.
Overall Number of Participants Analyzed 44
Median (95% Confidence Interval)
Unit of Measure: months
11.3
(2.0 to 20.6)
5.Secondary Outcome
Title Safety Assessment Criteria
Hide Description Security and tolerance to the study medication will be determined evaluating the type, incidence, severity, timing, seriousness and connections with the treatment of the reported adverse events, physical examinations and laboratory tests. Toxicity will be classified according to NCI-CTCAE v 4.0.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participantes with grade 3 or 4 AEs
Arm/Group Title Arm of Pazopanib
Hide Arm/Group Description:
Single arm of pazopanib 800 mg, administered once a day as the only treatment.
Overall Number of Participants Analyzed 44
Measure Type: Count of Participants
Unit of Measure: Participants
28
  63.6%
6.Secondary Outcome
Title Predictive Value of Baseline CTC (Count of 0) for Response to Treatma
Hide Description Predictive value of the differente biomarkers included in the study was evaluated using multivariate analysis.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm of Pazopanib
Hide Arm/Group Description:
Single arm of pazopanib 800 mg, administered once a day as the only treatment.
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Odds ratio
6.2
(0.45 to 86.5)
Time Frame 4 years, 8 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm of Pazopanib
Hide Arm/Group Description Single arm of pazopanib 800 mg, administered once a day as the only treatment.
All-Cause Mortality
Arm of Pazopanib
Affected / at Risk (%)
Total   1/44 (2.27%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm of Pazopanib
Affected / at Risk (%) # Events
Total   19/44 (43.18%)    
Cardiac disorders   
ACUTE CORONARY SYNDROME * 1  1/44 (2.27%)  1
Endocrine disorders   
DIABETIC DECOMPENSATION * 1  1/44 (2.27%)  1
Gastrointestinal disorders   
INTESTINAL SUBOCLUSION * 1  1/44 (2.27%)  1
Dysphagia * 1  1/44 (2.27%)  1
INTESTINAL OBSTRUCTION * 1  2/44 (4.55%)  4
INTESTINAL BLEEDING * 1  1/44 (2.27%)  1
VOMITING * 1  1/44 (2.27%)  1
General disorders   
ABDOMINAL PAIN * 1  1/44 (2.27%)  1
PROGRESSION DISEASE * 1  1/44 (2.27%)  1
Hepatobiliary disorders   
HEPATOTOXICITY * 1  1/44 (2.27%)  1
OBSTRUCTIVE ICTERY * 1  1/44 (2.27%)  1
ALT AND AST INCREASE * 1  1/44 (2.27%)  1
COLANGITIS * 1  1/44 (2.27%)  3
HEPATIC ENCEPHALOPATHY * 1  1/44 (2.27%)  1
BILIARY STENOSIS * 1  1/44 (2.27%)  1
HYPERTRANSAMINASEMIA * 1  1/44 (2.27%)  1
LIVER FAILURE * 1  1/44 (2.27%)  1
Infections and infestations   
RESPIRATORY INFECTION BY E.COLI * 1  1/44 (2.27%)  1
ACTIVE TUBERCULOSIS * 1  1/44 (2.27%)  1
Injury, poisoning and procedural complications   
INJURY IN HYPOPHYSIS * 1  1/44 (2.27%)  1
Metabolism and nutrition disorders   
HYPERGLUCEMIA * 1  1/44 (2.27%)  1
COMA HYPOGLYCEMIC * 1  1/44 (2.27%)  1
Musculoskeletal and connective tissue disorders   
OLIGOARTRALGIAS * 1  1/44 (2.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
TUMORAL PAIN * 1  1/44 (2.27%)  1
Psychiatric disorders   
GENERALIZED CRISIS * 1  1/44 (2.27%)  1
Renal and urinary disorders   
RENAL INSUFFICIENCY * 1  1/44 (2.27%)  1
Skin and subcutaneous tissue disorders   
CELLULITIS * 1  1/44 (2.27%)  1
Vascular disorders   
HYPERTENSIVE CRISIS * 1  1/44 (2.27%)  1
CEREBELLY HEMATOMY * 1  1/44 (2.27%)  1
DISSEMINATED INTRAVASCULAR COAGULATION * 1  1/44 (2.27%)  1
1
Term from vocabulary, NCI CTCAE, version 4
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm of Pazopanib
Affected / at Risk (%) # Events
Total   0/44 (0.00%)    
Small sample size, heterogeneous location and degree of differentiation of primary tumors, and lack of an appropriate control group. Additionally,response was evaluated by the investigator and not by an independent committee.
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
Name/Title: Dr. Enrique Grande (Hospital Universitario Ramón y Cajal)
Organization: Group for Neuroendocrine Tumors (GETNE)
Phone: 931780742 ext 201
Responsible Party: Grupo Espanol de Tumores Neuroendocrinos
ClinicalTrials.gov Identifier: NCT01280201     History of Changes
Other Study ID Numbers: GETNE-1002
2010-020749-28 ( EudraCT Number )
First Submitted: January 19, 2011
First Posted: January 20, 2011
Results First Submitted: May 16, 2017
Results First Posted: March 4, 2019
Last Update Posted: May 29, 2019