Trial Outcomes & Findings for Monotherapy Pazopanib in Subjects With Advanced Non-Small Cell Lung Cancer (NCT NCT00549328)
NCT ID: NCT00549328
Last Updated: 2014-11-19
Results Overview
The best overall response using Response Evaluation Criteria In Solid Tumors (RESIST) was measured. Complete response is defined as the disappearance of all known lesion(s), confirmed at 4 weeks, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks. No formal efficacy analyses were performed due to early termination of the study.
TERMINATED
PHASE2
14 participants
Baseline through End of Study (up to 2 years)
2014-11-19
Participant Flow
Participant milestones
| Measure |
Pazopanib 800 mg
Pazopanib 800 milligrams (mg) monotherapy given orally once daily
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Pazopanib 800 mg
Pazopanib 800 milligrams (mg) monotherapy given orally once daily
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Disease Progression
|
10
|
|
Overall Study
Death
|
1
|
|
Overall Study
Use of Prohibited Medication
|
1
|
Baseline Characteristics
Monotherapy Pazopanib in Subjects With Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pazopanib 800 mg
n=14 Participants
Pazopanib 800 milligrams (mg) monotherapy given orally once daily
|
|---|---|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 7.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through End of Study (up to 2 years)Population: All Treated Population: all participants who met inclusion criteria and willingly consented to participate in the study
The best overall response using Response Evaluation Criteria In Solid Tumors (RESIST) was measured. Complete response is defined as the disappearance of all known lesion(s), confirmed at 4 weeks, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks. No formal efficacy analyses were performed due to early termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through End of Study (up to 2 years)Population: All Treated Population
Disease control was measured. Stable disease (SD) is defined as neither partial response (at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks) nor progressive disease (PD; a 20% increase in the sum of the longest diameters of target lesions, taken as a reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions. No formal efficacy analyses were performed due to early termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through End of Study (up to 2 years)Population: All Treated Population
Progression-free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause, whichever occurs first. No formal efficacy analyses were performed due to early termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through End of Study (up to 2 years)Population: All Treated Population
Overall survival is defined as the time from the start of treatment until death due to any cause. No formal efficacy analyses were performed due to early termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through End of Study (up to 2 years)Population: All Treated Population
Biomarkers are proteins that respond in a unique way to treatment with the study drug; however, levels of proteins were not collected for this measurement. No formal efficacy analyses were performed due to early termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through End of Study (up to 2 years)Population: All Treated Population
Biomarkers are proteins that respond in a unique way to treatment with the study drug; however, levels of proteins were not collected for this measurement. No formal efficacy analyses were performed due to early termination of the study.
Outcome measures
Outcome data not reported
Adverse Events
Pazopanib 800 mg
Serious adverse events
| Measure |
Pazopanib 800 mg
n=14 participants at risk
Pazopanib 800 milligrams (mg) monotherapy given orally once daily
|
|---|---|
|
Vascular disorders
Hypertension
|
7.1%
1/14
|
Other adverse events
| Measure |
Pazopanib 800 mg
n=14 participants at risk
Pazopanib 800 milligrams (mg) monotherapy given orally once daily
|
|---|---|
|
General disorders
Fatigue
|
57.1%
8/14
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
6/14
|
|
Gastrointestinal disorders
Nausea
|
42.9%
6/14
|
|
Gastrointestinal disorders
Constipation
|
28.6%
4/14
|
|
Gastrointestinal disorders
Dyspepsia
|
28.6%
4/14
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
4/14
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
4/14
|
|
Gastrointestinal disorders
Stomatitis
|
21.4%
3/14
|
|
Nervous system disorders
Headache
|
21.4%
3/14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.4%
3/14
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
21.4%
3/14
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
21.4%
3/14
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
21.4%
3/14
|
|
Skin and subcutaneous tissue disorders
Hair color changes
|
21.4%
3/14
|
|
Investigations
Weight decreased
|
21.4%
3/14
|
|
Vascular disorders
Hypertension
|
21.4%
3/14
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER