Trial Outcomes & Findings for Pazopanib as Single Agent in Advanced NETs (NCT NCT01280201)
NCT ID: NCT01280201
Last Updated: 2019-05-29
Results Overview
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.
COMPLETED
PHASE2
44 participants
6 months
2019-05-29
Participant Flow
Between January 2011 and March 2012, a total of 44 patients were enrolled at 9 Spanish sites, belonging to Group for Neuroendocrine Tumors (GETNE).
Participant milestones
| Measure |
Arm of Pazopanib
Single arm of pazopanib 800 mg, administered once a day as the only treatment.
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm of Pazopanib
n=44 Participants
Single arm of pazopanib 800 mg, administered once a day as the only treatment.
|
|---|---|
|
Age, Continuous
|
60 years
n=44 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=44 Participants
|
|
Region of Enrollment
Spain
|
44 participants
n=44 Participants
|
|
Tumor type
Pancreatic islet cell tumors
|
18 Participants
n=44 Participants
|
|
Tumor type
Gastrointestinal neuroendocrine tumors
|
15 Participants
n=44 Participants
|
|
Tumor type
Pulmonary carcinoid tumors
|
5 Participants
n=44 Participants
|
|
Tumor type
Thymic carcinoid tumors
|
3 Participants
n=44 Participants
|
|
Tumor type
Unknown primary origin tumors
|
3 Participants
n=44 Participants
|
|
Functional tumor status
Functional
|
13 participants
n=44 Participants
|
|
Functional tumor status
Nonfunctional
|
31 participants
n=44 Participants
|
|
Histologic status of tumor
Well differentiated
|
30 Participants
n=44 Participants
|
|
Histologic status of tumor
Moderately differentiated
|
3 Participants
n=44 Participants
|
|
Histologic status of tumor
Poorly differentiated
|
2 Participants
n=44 Participants
|
|
Histologic status of tumor
Unknown
|
9 Participants
n=44 Participants
|
|
Ki67 index
≤2%
|
6 participants
n=44 Participants
|
|
Ki67 index
3%-10%
|
13 participants
n=44 Participants
|
|
Ki67 index
>10%
|
5 participants
n=44 Participants
|
|
Ki67 index
Unknown
|
20 participants
n=44 Participants
|
|
Previous biologic treatment
Everolimus
|
11 Participants
n=44 Participants
|
|
Previous biologic treatment
Multitargeted agent
|
16 Participants
n=44 Participants
|
|
Previous biologic treatment
mTOR and multitargeted inhibitor
|
8 Participants
n=44 Participants
|
|
Previous biologic treatment
None
|
9 Participants
n=44 Participants
|
|
Previous chemotherapy
|
16 Participants
n=44 Participants
|
|
Previous somatostatin analogs
|
35 Participants
n=44 Participants
|
|
Concurrent somatostatin analogs
|
30 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPer 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.
Outcome measures
| Measure |
Arm of Pazopanib
n=15 Participants
Single arm of pazopanib 800 mg, administered once a day as the only treatment.
|
|---|---|
|
Clinical Benefit Rate
|
11 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPer 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.
Outcome measures
| Measure |
Arm of Pazopanib
n=40 Participants
Single arm of pazopanib 800 mg, administered once a day as the only treatment.
|
|---|---|
|
Number of Patients Who Had an Event (Disease Progression or Death)
|
35 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPer 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.
Outcome measures
| Measure |
Arm of Pazopanib
n=44 Participants
Single arm of pazopanib 800 mg, administered once a day as the only treatment.
|
|---|---|
|
Radiological Objective Complete Response Rate
|
4 Participants
|
SECONDARY outcome
Timeframe: 3 yearsDefined, 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.
Outcome measures
| Measure |
Arm of Pazopanib
n=44 Participants
Single arm of pazopanib 800 mg, administered once a day as the only treatment.
|
|---|---|
|
Duration of Response (DoR)
|
11.3 months
Interval 2.0 to 20.6
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Number of participantes with grade 3 or 4 AEs
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.
Outcome measures
| Measure |
Arm of Pazopanib
n=44 Participants
Single arm of pazopanib 800 mg, administered once a day as the only treatment.
|
|---|---|
|
Safety Assessment Criteria
|
28 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPredictive value of the differente biomarkers included in the study was evaluated using multivariate analysis.
Outcome measures
| Measure |
Arm of Pazopanib
n=44 Participants
Single arm of pazopanib 800 mg, administered once a day as the only treatment.
|
|---|---|
|
Predictive Value of Baseline CTC (Count of 0) for Response to Treatma
|
6.2 Odds ratio
Interval 0.45 to 86.5
|
Adverse Events
Arm of Pazopanib
Serious adverse events
| Measure |
Arm of Pazopanib
n=44 participants at risk
Single arm of pazopanib 800 mg, administered once a day as the only treatment.
|
|---|---|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Endocrine disorders
DIABETIC DECOMPENSATION
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Gastrointestinal disorders
INTESTINAL SUBOCLUSION
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Metabolism and nutrition disorders
HYPERGLUCEMIA
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Psychiatric disorders
GENERALIZED CRISIS
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Hepatobiliary disorders
OBSTRUCTIVE ICTERY
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
OLIGOARTRALGIAS
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Infections and infestations
RESPIRATORY INFECTION BY E.COLI
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Infections and infestations
ACTIVE TUBERCULOSIS
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Vascular disorders
CEREBELLY HEMATOMY
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Hepatobiliary disorders
ALT AND AST INCREASE
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Skin and subcutaneous tissue disorders
CELLULITIS
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Vascular disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Hepatobiliary disorders
COLANGITIS
|
2.3%
1/44 • Number of events 3 • 4 years, 8 months
|
|
Metabolism and nutrition disorders
COMA HYPOGLYCEMIC
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Gastrointestinal disorders
Dysphagia
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
General disorders
ABDOMINAL PAIN
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMORAL PAIN
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Hepatobiliary disorders
HEPATIC ENCEPHALOPATHY
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Hepatobiliary disorders
BILIARY STENOSIS
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Hepatobiliary disorders
HYPERTRANSAMINASEMIA
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Hepatobiliary disorders
LIVER FAILURE
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Renal and urinary disorders
RENAL INSUFFICIENCY
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Injury, poisoning and procedural complications
INJURY IN HYPOPHYSIS
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
4.5%
2/44 • Number of events 4 • 4 years, 8 months
|
|
General disorders
PROGRESSION DISEASE
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Gastrointestinal disorders
INTESTINAL BLEEDING
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
|
Gastrointestinal disorders
VOMITING
|
2.3%
1/44 • Number of events 1 • 4 years, 8 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Enrique Grande (Hospital Universitario Ramón y Cajal)
Group for Neuroendocrine Tumors (GETNE)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place