Trial Outcomes & Findings for Pazopanib in Molecularly Selected Patients With Advanced NSCLC (NCT NCT02193152)
NCT ID: NCT02193152
Last Updated: 2020-07-14
Results Overview
* Participants should be re-evaluated for response 8 weeks after initiation of pazopanib and then every 8 weeks thereafter. In addition to a baseline scan, confirmatory scans should also be obtained not less than 4 weeks following initial documentation of objective response. * Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) \[Eur J Ca 45:228-247, 2009\]. * Response rate is the percentage of participants with a complete or partial response * Complete response=Disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). * Partial response=At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Until the end of treatment (median length of treatment=85.5 days (full range 25-334 days)
Results posted on
2020-07-14
Participant Flow
Participant milestones
| Measure |
Treatment: Pazopanib
Pazopanib 800 mg daily should be taken orally without food at least one hour before or two hours after a meal.
One cycle of pazopanib is 28 days.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pazopanib in Molecularly Selected Patients With Advanced NSCLC
Baseline characteristics by cohort
| Measure |
Treatment: Pazopanib
n=16 Participants
Pazopanib 800 mg daily should be taken orally without food at least one hour before or two hours after a meal.
One cycle of pazopanib is 28 days.
|
|---|---|
|
Age, Continuous
|
66.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 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
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until the end of treatment (median length of treatment=85.5 days (full range 25-334 days)Population: 4 participants were not evaluable for this outcome measure because they were removed from treatment prior to the re-evaluation response at 8 weeks
* Participants should be re-evaluated for response 8 weeks after initiation of pazopanib and then every 8 weeks thereafter. In addition to a baseline scan, confirmatory scans should also be obtained not less than 4 weeks following initial documentation of objective response. * Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) \[Eur J Ca 45:228-247, 2009\]. * Response rate is the percentage of participants with a complete or partial response * Complete response=Disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). * Partial response=At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
Outcome measures
| Measure |
Treatment: Pazopanib
n=12 Participants
Pazopanib 800 mg daily should be taken orally without food at least one hour before or two hours after a meal.
One cycle of pazopanib is 28 days.
|
|---|---|
|
Response Rate
|
2 Participants
|
PRIMARY outcome
Timeframe: Until progressive disease or death (median follow-up 174 days, full range 41 days-545 days)* Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. There is no limit on following for progression-free survival besides death of the participant. * Progressive disease=At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Outcome measures
| Measure |
Treatment: Pazopanib
n=16 Participants
Pazopanib 800 mg daily should be taken orally without food at least one hour before or two hours after a meal.
One cycle of pazopanib is 28 days.
|
|---|---|
|
Progression-free Survival (PFS)
|
13.25 weeks
Interval 3.5 to 47.8
|
SECONDARY outcome
Timeframe: Until time of death (an expected average of 8 months)Population: The data was not collected for this outcome measure.
* Participants are followed until death. * All participants will undergo next generation sequencing prior to enrollment into the study. * Initial predictors are the mutations in VEGFR or PDGFR, but sequencing will be used to evaluate for other predictors as well.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until end of treatment (an expected average of 8 months)Population: The data was not collected for this outcome measure.
-Whole exome and transcriptome sequencing will be performed in 10 participants, including 4 to 6 responders and 4 to 6 non-responders in order to identify the predictors for benefit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until the time of progressive disease (an expected average of 8 months)Population: The data was not collected for this outcome measure.
-Participants will also undergo next generation sequencing at the time of progression in an attempt to identify the mechanisms for secondary resistance.
Outcome measures
Outcome data not reported
Adverse Events
Treatment: Pazopanib
Serious events: 8 serious events
Other events: 16 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Treatment: Pazopanib
n=16 participants at risk
Pazopanib 800 mg daily should be taken orally without food at least one hour before or two hours after a meal.
One cycle of pazopanib is 28 days.
|
|---|---|
|
General disorders
Fatigue
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
General disorders
Fever
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Infections and infestations
Lung infection
|
18.8%
3/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Infections and infestations
Upper respiratory infection
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Investigations
Death
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
2/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
Other adverse events
| Measure |
Treatment: Pazopanib
n=16 participants at risk
Pazopanib 800 mg daily should be taken orally without food at least one hour before or two hours after a meal.
One cycle of pazopanib is 28 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Cardiac disorders
Tachycardia
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Eye disorders
Visual changes
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Endocrine disorders
Hypothryoidism
|
18.8%
3/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
4/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Gastrointestinal disorders
Constipation
|
68.8%
11/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Gastrointestinal disorders
Diarrhea
|
31.2%
5/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Gastrointestinal disorders
Dyspepsia
|
43.8%
7/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Gastrointestinal disorders
Gingival pain
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Gastrointestinal disorders
Mucositis oral
|
31.2%
5/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Gastrointestinal disorders
Nausea
|
68.8%
11/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Gastrointestinal disorders
Vomiting
|
31.2%
5/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
General disorders
Chills
|
37.5%
6/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
General disorders
Dry mouth
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
General disorders
Edema limbs
|
43.8%
7/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
General disorders
Edema face
|
12.5%
2/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
General disorders
Fatigue
|
87.5%
14/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
General disorders
Leg pain
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
General disorders
Non-cardiac chest pain
|
12.5%
2/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
General disorders
Foot pain
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
General disorders
Left side pain
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
General disorders
Fever
|
12.5%
2/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
General disorders
Flu like symptoms
|
12.5%
2/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
General disorders
Hip pain
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
General disorders
Shoulder pain
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Infections and infestations
Papulopustular rash
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Infections and infestations
Lung infection
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Infections and infestations
Infection
|
18.8%
3/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Investigations
Platelet count decreased
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
2/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Investigations
Creatinine increased
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Investigations
Weight loss
|
12.5%
2/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Metabolism and nutrition disorders
Anorexia
|
62.5%
10/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
43.8%
7/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
31.2%
5/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
37.5%
6/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Musculoskeletal and connective tissue disorders
Left shoulder pain
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Nervous system disorders
Dizziness
|
62.5%
10/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Nervous system disorders
Headache
|
56.2%
9/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
75.0%
12/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Nervous system disorders
Memory impairment
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
31.2%
5/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Nervous system disorders
Dysgeusia
|
18.8%
3/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Psychiatric disorders
Anxiety
|
31.2%
5/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Psychiatric disorders
Depression
|
31.2%
5/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Psychiatric disorders
Insomnia
|
75.0%
12/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Psychiatric disorders
Confusion
|
18.8%
3/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Renal and urinary disorders
Polyuria
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
75.0%
12/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
68.8%
11/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
12.5%
2/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
37.5%
6/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Skin and subcutaneous tissue disorders
Bruising
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
4/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
18.8%
3/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
25.0%
4/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysethesia
|
12.5%
2/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Vascular disorders
Hot flashes
|
37.5%
6/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Vascular disorders
Hypertension
|
56.2%
9/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
|
Vascular disorders
Thromboembolic event
|
6.2%
1/16 • Adverse events were collected from study start through 30 days after completion of treatment (median treatment length 85.5 days (full range=25 days-334 days)).
|
Additional Information
Daniel Morgensztern, M.D.
Washington University School of Medicine
Phone: 314-362-5737
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place