Trial Outcomes & Findings for Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma (NCT NCT01462630)
NCT ID: NCT01462630
Last Updated: 2022-08-19
Results Overview
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. PFS was estimated using the method of Kaplan and Meier.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
3 months
Results posted on
2022-08-19
Participant Flow
Participant milestones
| Measure |
Treatment (Enzyme Inhibitor Therapy)
Patients receive pazopanib hydrochloride PO QD. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
positron emission tomography: Correlative studies
computed tomography: Correlative studies
fludeoxyglucose F 18: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Treatment (Enzyme Inhibitor Therapy)
Patients receive pazopanib hydrochloride PO QD. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
positron emission tomography: Correlative studies
computed tomography: Correlative studies
fludeoxyglucose F 18: Correlative studies
|
|---|---|
|
Overall Study
Did not initiate therapy
|
3
|
|
Overall Study
Death
|
1
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma
Baseline characteristics by cohort
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=29 Participants
Patients receive pazopanib hydrochloride PO QD. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
positron emission tomography: Correlative studies
computed tomography: Correlative studies
fludeoxyglucose F 18: Correlative studies
|
|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Of the 26 patients who started therapy, response was not evaluable in 8 patients due to lab abnormalities at C1D1 (n=1), consent withdrawal (n=2), toxicity (n=4), and non-compliance (n=1)
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. PFS was estimated using the method of Kaplan and Meier.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=18 Participants
Patients receive pazopanib hydrochloride PO QD. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
positron emission tomography: Correlative studies
computed tomography: Correlative studies
fludeoxyglucose F 18: Correlative studies
|
|---|---|
|
PFS Rate
|
54.6 percentage of patients
Interval 36.0 to 82.9
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 7 of 29 patients were not evaluable for response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Standard estimates of the binomial proportion will be used to estimate and place confidence bounds on the several response rates.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=22 Participants
Patients receive pazopanib hydrochloride PO QD. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
positron emission tomography: Correlative studies
computed tomography: Correlative studies
fludeoxyglucose F 18: Correlative studies
|
|---|---|
|
Response Rate Defined as CR
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 7 of 29 patients were not evaluable for response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Standard estimates of the binomial proportion will be used to estimate and place confidence bounds on the several response rates.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=22 Participants
Patients receive pazopanib hydrochloride PO QD. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
positron emission tomography: Correlative studies
computed tomography: Correlative studies
fludeoxyglucose F 18: Correlative studies
|
|---|---|
|
Response Rate Defined as Partial Response (PR)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 107 weeksEstimated using the method of Kaplan and Meier.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=22 Participants
Patients receive pazopanib hydrochloride PO QD. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
positron emission tomography: Correlative studies
computed tomography: Correlative studies
fludeoxyglucose F 18: Correlative studies
|
|---|---|
|
Overall Survival of Patients Treated With Pazopanib Hydrochloride
|
69.8 weeks
Interval 42.3 to 106.7
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All patients initially enrolled were followed for toxicities
Toxicities related/unrelated to study treatment with \>10% frequency
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=29 Participants
Patients receive pazopanib hydrochloride PO QD. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
positron emission tomography: Correlative studies
computed tomography: Correlative studies
fludeoxyglucose F 18: Correlative studies
|
|---|---|
|
Evaluation of Toxicity of Pazopanib Hydrochloride in This Patient Population
|
189 toxicities
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: No data collected for comparison
Descriptive statistics will include mean, SD, median, minimum, and maximum for continuous variables and the numbers and percentages for categorical variables. Summary statistics for changes in SUVs, tumor to background ratios, lesion size, and comparison scores will be analyzed and presented.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Enzyme Inhibitor Therapy)
Serious events: 13 serious events
Other events: 29 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=29 participants at risk
Patients receive pazopanib hydrochloride PO QD. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
positron emission tomography: Correlative studies
computed tomography: Correlative studies
fludeoxyglucose F 18: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
anemia
|
3.4%
1/29 • Number of events 1 • 2 years
|
|
Investigations
Bilirubin increase
|
6.9%
2/29 • 2 years
|
|
Investigations
alanine aminotransferase increase
|
13.8%
4/29 • 2 years
|
|
Investigations
Aspartate aminotransferase increase
|
6.9%
2/29 • 2 years
|
|
Gastrointestinal disorders
abdominal pain
|
6.9%
2/29 • 2 years
|
|
Blood and lymphatic system disorders
low platelet
|
3.4%
1/29 • 2 years
|
|
Renal and urinary disorders
Urinary tract infection
|
3.4%
1/29 • 2 years
|
|
General disorders
Death
|
3.4%
1/29 • 2 years
|
|
Cardiac disorders
pericardial effusion
|
6.9%
2/29 • 2 years
|
|
General disorders
edema
|
3.4%
1/29 • 2 years
|
|
Skin and subcutaneous tissue disorders
rash
|
3.4%
1/29 • 2 years
|
|
Cardiac disorders
cardiac arrest/death
|
3.4%
1/29 • 2 years
|
|
Cardiac disorders
Acute coronary syndrome
|
3.4%
1/29 • 2 years
|
|
Gastrointestinal disorders
colitis
|
3.4%
1/29 • 2 years
|
|
Gastrointestinal disorders
dysphagia
|
3.4%
1/29 • 2 years
|
|
Gastrointestinal disorders
diarrhea
|
3.4%
1/29 • 2 years
|
Other adverse events
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=29 participants at risk
Patients receive pazopanib hydrochloride PO QD. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
positron emission tomography: Correlative studies
computed tomography: Correlative studies
fludeoxyglucose F 18: Correlative studies
|
|---|---|
|
Infections and infestations
Rhinitis
|
3.4%
1/29 • 2 years
|
|
Blood and lymphatic system disorders
Low hemoglobin
|
31.0%
9/29 • 2 years
|
|
Blood and lymphatic system disorders
Low absolute neutrophil count
|
10.3%
3/29 • 2 years
|
|
Investigations
Low white blood cell count
|
24.1%
7/29 • 2 years
|
|
Investigations
Lymphocyte count decrease
|
13.8%
4/29 • 2 years
|
|
General disorders
Edema
|
10.3%
3/29 • 2 years
|
|
Vascular disorders
Hypertension
|
48.3%
14/29 • 2 years
|
|
Vascular disorders
Ortho-hypotension
|
6.9%
2/29 • 2 years
|
|
Cardiac disorders
Palpitation
|
3.4%
1/29 • 2 years
|
|
Nervous system disorders
Dizzeness
|
27.6%
8/29 • 2 years
|
|
General disorders
Fatigue
|
62.1%
18/29 • 2 years
|
|
Psychiatric disorders
Anxiety
|
3.4%
1/29 • 2 years
|
|
General disorders
Chills
|
3.4%
1/29 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.4%
1/29 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hair color changes
|
3.4%
1/29 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.3%
3/29 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
3.4%
1/29 • 2 years
|
|
Immune system disorders
Palmer-Planter erythrodysesthia syndrome
|
3.4%
1/29 • 2 years
|
|
General disorders
Hemorrhage
|
3.4%
1/29 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
48.3%
14/29 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
34.5%
10/29 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
44.8%
13/29 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
1/29 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
10.3%
3/29 • 2 years
|
|
Gastrointestinal disorders
Heart burn
|
3.4%
1/29 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
27.6%
8/29 • 2 years
|
|
Gastrointestinal disorders
Anorexia
|
31.0%
9/29 • 2 years
|
|
Gastrointestinal disorders
Mucositis
|
27.6%
8/29 • 2 years
|
|
Investigations
Weight lose
|
6.9%
2/29 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
20.7%
6/29 • 2 years
|
|
Nervous system disorders
confusion
|
3.4%
1/29 • 2 years
|
|
Nervous system disorders
Insomnia
|
6.9%
2/29 • 2 years
|
|
Psychiatric disorders
Depression
|
10.3%
3/29 • 2 years
|
|
Nervous system disorders
Neuropathy-Motor
|
13.8%
4/29 • 2 years
|
|
Nervous system disorders
Neuropathy-Sensory
|
6.9%
2/29 • 2 years
|
|
Nervous system disorders
Blurred vision
|
10.3%
3/29 • 2 years
|
|
General disorders
Pain
|
48.3%
14/29 • 2 years
|
|
Nervous system disorders
Headache
|
48.3%
14/29 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myal-arthralgia
|
20.7%
6/29 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
24.1%
7/29 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nose bleeding
|
20.7%
6/29 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.2%
5/29 • 2 years
|
|
Endocrine disorders
Hypothyroidism
|
3.4%
1/29 • 2 years
|
|
Investigations
Alkaline phosphatase increase
|
20.7%
6/29 • 2 years
|
|
Investigations
Hyperbilirubinemia
|
27.6%
8/29 • 2 years
|
|
Investigations
SGOT increase
|
34.5%
10/29 • 2 years
|
|
Investigations
SGPT increase
|
34.5%
10/29 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.4%
1/29 • 2 years
|
|
Infections and infestations
Infection without neutropenia
|
10.3%
3/29 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.9%
2/29 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
27.6%
8/29 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.9%
2/29 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.3%
3/29 • 2 years
|
|
Investigations
Hyponatremia
|
13.8%
4/29 • 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.4%
1/29 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.3%
3/29 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.8%
4/29 • 2 years
|
|
Investigations
Elevated creatinine
|
13.8%
4/29 • 2 years
|
|
Renal and urinary disorders
Urinary tract infection
|
10.3%
3/29 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
1/29 • 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
34.5%
10/29 • 2 years
|
|
Investigations
Transaminitis
|
44.8%
13/29 • 2 years
|
Additional Information
Protocol Development Coordinator
Fox Chase Cancer Center
Phone: 215-728-4097
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place