Trial Outcomes & Findings for Pazopanib In Stage IIIB/IV NSCLC Lung Cancer After Progression on First Line Therapy Containing Bevacizumab (NCT NCT01262820)
NCT ID: NCT01262820
Last Updated: 2017-03-07
Results Overview
Response (CR + PR + SD) as defined by RECIST v1.1 lasting equal to or greater than 12 weeks in patients treated with pazopanib alone for stage IIIB/IV non-squamous NSCLC after progression on first line therapy containing bevacizumab Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Complete Response (CR) is defined as Disappearance of all target lesions; Partial Response (PR), as a \>=30% decrease in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions; Progression, as a 20% increase in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. Target lesions are representative of all involved organs and measurable by radiographic imaging.
COMPLETED
PHASE2
15 participants
Eight (8) months w additional time for response date to mature (up to 2 years per participant)
2017-03-07
Participant Flow
Subjects were recruited between April 2010 and January 2014
A total of 22 patients provided informed consent for this trial; 7 patients were considered ineligible leaving 15 patients who enrolled and were treated on study.
Participant milestones
| Measure |
Single Intervention
Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Single Intervention
Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Lack of Efficacy
|
9
|
|
Overall Study
Drug held for 21+ days
|
1
|
Baseline Characteristics
Pazopanib In Stage IIIB/IV NSCLC Lung Cancer After Progression on First Line Therapy Containing Bevacizumab
Baseline characteristics by cohort
| Measure |
Single Intervention
n=15 Participants
Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Eight (8) months w additional time for response date to mature (up to 2 years per participant)Response (CR + PR + SD) as defined by RECIST v1.1 lasting equal to or greater than 12 weeks in patients treated with pazopanib alone for stage IIIB/IV non-squamous NSCLC after progression on first line therapy containing bevacizumab Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Complete Response (CR) is defined as Disappearance of all target lesions; Partial Response (PR), as a \>=30% decrease in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions; Progression, as a 20% increase in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. Target lesions are representative of all involved organs and measurable by radiographic imaging.
Outcome measures
| Measure |
Single Intervention
n=15 Participants
Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle
|
|---|---|
|
Disease Control Rate
|
13 % of participants with disease control
Interval 2.0 to 40.0
|
SECONDARY outcome
Timeframe: 8 months with additional time for response to mature (up to 2 years per participant)Estimate of combined response rate (Complete Response (CR) + Partial Response (PR) per RECIST v1.1 Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Complete Response (CR) is defined as the disappearance of all target lesions and Partial Response (PR) as a \>=30% decrease in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions.Target lesions are representative of all involved organs and measurable by radiographic imaging.
Outcome measures
| Measure |
Single Intervention
n=15 Participants
Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle
|
|---|---|
|
Combined Response Rate (CR + PR) of Pazopanib According to RECIST v1.1
|
0 participants
|
SECONDARY outcome
Timeframe: Eight (8) months w additional time for response data to mature (up to 2 years per participant)Progression free survival is defined as time of enrollment until disease progression or death Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Progression is defined as a 20% increase in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Target lesions are representative of all involved organs and measurable by radiographic imaging.
Outcome measures
| Measure |
Single Intervention
n=15 Participants
Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle
|
|---|---|
|
Progression Free Survival
|
10.9 weeks
Interval 8.1 to 18.9
|
SECONDARY outcome
Timeframe: Eight (8) months w additional time for response date to mature (up to 2 years per participant)Overall survival is defined as the time of enrollment until death
Outcome measures
| Measure |
Single Intervention
n=15 Participants
Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle
|
|---|---|
|
Overall Survival
|
24.1 weeks
Interval 20.3 to 33.7
|
Adverse Events
Single Intervention
Serious adverse events
| Measure |
Single Intervention
n=15 participants at risk
Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle
|
|---|---|
|
Psychiatric disorders
Confusion
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • Number of events 2 • 4 years
|
|
Infections and infestations
Lung Infection
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pericardial Effusion
|
6.7%
1/15 • Number of events 2 • 4 years
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Nervous system disorders
intracranial hemorrhage
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
General disorders
Flu like symptoms
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.7%
1/15 • Number of events 1 • 4 years
|
Other adverse events
| Measure |
Single Intervention
n=15 participants at risk
Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
13.3%
2/15 • Number of events 2 • 4 years
|
|
Investigations
Alanine Aminotransferase Increased
|
20.0%
3/15 • Number of events 6 • 4 years
|
|
Investigations
Alkaline Phosphatase Increased
|
20.0%
3/15 • Number of events 4 • 4 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.3%
2/15 • Number of events 2 • 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
13.3%
2/15 • Number of events 3 • 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
60.0%
9/15 • Number of events 9 • 4 years
|
|
Psychiatric disorders
Anxiety
|
13.3%
2/15 • Number of events 2 • 4 years
|
|
Investigations
Aspartate Aminotransferase Increased
|
33.3%
5/15 • Number of events 8 • 4 years
|
|
Investigations
Blood Bilirubin Increased
|
6.7%
1/15 • Number of events 2 • 4 years
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Number of events 2 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Investigations
Creatinine Increased
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
2/15 • Number of events 2 • 4 years
|
|
Psychiatric disorders
Depression
|
13.3%
2/15 • Number of events 3 • 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
26.7%
4/15 • Number of events 5 • 4 years
|
|
Nervous system disorders
Dysgeusia
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Number of events 3 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
3/15 • Number of events 3 • 4 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Esophageal Pain
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
General disorders
Fatigue
|
46.7%
7/15 • Number of events 12 • 4 years
|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 4 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Investigations
Ggt Increased
|
13.3%
2/15 • Number of events 5 • 4 years
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 4 • 4 years
|
|
Investigations
Hemoglobin Increased
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Hepatobiliary disorders
Hepatitis viral
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Vascular disorders
Hot Flashes
|
13.3%
2/15 • Number of events 2 • 4 years
|
|
Vascular disorders
Hypertension
|
40.0%
6/15 • Number of events 8 • 4 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
1/15 • Number of events 2 • 4 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
13.3%
2/15 • Number of events 2 • 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.3%
2/15 • Number of events 4 • 4 years
|
|
Psychiatric disorders
Insomnia
|
13.3%
2/15 • Number of events 2 • 4 years
|
|
Investigations
Lipase Increased
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Infections and infestations
Lung Infection
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Investigations
Lymphocyte Count Decreased
|
13.3%
2/15 • Number of events 2 • 4 years
|
|
Gastrointestinal disorders
Mucositis Oral
|
20.0%
3/15 • Number of events 7 • 4 years
|
|
Gastrointestinal disorders
Nausea
|
53.3%
8/15 • Number of events 14 • 4 years
|
|
Investigations
Neutrophil Count Decreased
|
13.3%
2/15 • Number of events 2 • 4 years
|
|
General disorders
Non-Cardiac Chest Pain
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Oral Hemorrhage
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
General disorders
Pain
|
20.0%
3/15 • Number of events 4 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
20.0%
3/15 • Number of events 3 • 4 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
13.3%
2/15 • Number of events 3 • 4 years
|
|
Investigations
Platelet Count Decreased
|
13.3%
2/15 • Number of events 2 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Renal and urinary disorders
Proteinuria
|
13.3%
2/15 • Number of events 2 • 4 years
|
|
Skin and subcutaneous tissue disorders
Pruitus
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Renal and urinary disorders
Renal And Urinary Disorders - Other, Specify
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other, Specify
|
6.7%
1/15 • Number of events 3 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
13.3%
2/15 • Number of events 2 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
6.7%
1/15 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
5/15 • Number of events 10 • 4 years
|
|
Investigations
Weight Loss
|
33.3%
5/15 • Number of events 5 • 4 years
|
|
Investigations
White Blood Cell Decreased
|
13.3%
2/15 • Number of events 2 • 4 years
|
Additional Information
Robin V. Johnson
UNC Lineberger Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place