Trial Outcomes & Findings for Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer (NCT NCT01767636)
NCT ID: NCT01767636
Last Updated: 2025-03-03
Results Overview
Overall survival rate at 12 months is defined as the percentage of participants who are alive at 12 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
12 months
Results posted on
2025-03-03
Participant Flow
Participant milestones
| Measure |
Treatment (Pazopanib Hydrochloride)
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Pazopanib Hydrochloride)
n=35 Participants
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 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
|
|
ECOG Performance Score at baseline
0
|
21 Participants
n=5 Participants
|
|
ECOG Performance Score at baseline
1
|
12 Participants
n=5 Participants
|
|
ECOG Performance Score at baseline
2
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Evaluable participants are included in this analysis.
Overall survival rate at 12 months is defined as the percentage of participants who are alive at 12 months.
Outcome measures
| Measure |
Treatment (Pazopanib Hydrochloride)
n=35 Participants
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival Rate at 12 Months
|
65.7 percentage of participants
Interval 50.5 to 78.9
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Evaluable participants are included in this analysis.
Number of participants experiencing at least one toxicity defined as a grade 3 or higher adverse event deemed at least possible related to treatment.
Outcome measures
| Measure |
Treatment (Pazopanib Hydrochloride)
n=35 Participants
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants Experiencing at Least One Toxicity
|
17 Participants
|
SECONDARY outcome
Timeframe: From registration to the earliest date documentation of disease progression or death, assessed up to 2 yearsPopulation: Evaluable participants are included in this analysis.
Kaplan-Meier curve will be used to estimate progression-free survival time. Progression is defined as At least one of the following must be true:a. At least one new malignant lesion, which also includes any lymph node that was normal at baseline (\< 1.0 cm short axis) and increased to ≥ 1.0 cm short axis during follow-up. b. At least a 20% increase in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the MSD. In addition, the PBSD must also demonstrate an absolute increase of at least 0.5 cm from the MSD.
Outcome measures
| Measure |
Treatment (Pazopanib Hydrochloride)
n=35 Participants
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival
|
7.5 months
Interval 5.0 to 11.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Evaluable participants are included in this analysis.
Overall survival is defined as the time from study registration to death date.
Outcome measures
| Measure |
Treatment (Pazopanib Hydrochloride)
n=35 Participants
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
18.9 months
Interval 13.0 to
The 90% confidence interval upper limit was not reached (i.e. below the level of detection).
|
SECONDARY outcome
Timeframe: Up to 56 daysPopulation: Evaluable participants are included in this analysis.
The number of participants with Best tumor response in the first 2 cycles. Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the BSD. Progression is defined as At least one of the following must be true:a. At least one new malignant lesion, which also includes any lymph node that was normal at baseline (\< 1.0 cm short axis) and increased to ≥ 1.0 cm short axis during follow-up. b. At least a 20% increase in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the MSD. In addition, the PBSD must also demonstrate an absolute increase of at least 0.5 cm from the MSD.Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD.
Outcome measures
| Measure |
Treatment (Pazopanib Hydrochloride)
n=35 Participants
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants With Best Response in the First 2 Cycles
Partial Response (PR)
|
4 Participants
|
|
Number of Participants With Best Response in the First 2 Cycles
Stable Disease (SD)
|
21 Participants
|
|
Number of Participants With Best Response in the First 2 Cycles
Progression (PD)
|
3 Participants
|
|
Number of Participants With Best Response in the First 2 Cycles
Not Evaluated
|
7 Participants
|
Adverse Events
Treatment (Pazopanib Hydrochloride)
Serious events: 10 serious events
Other events: 34 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Treatment (Pazopanib Hydrochloride)
n=35 participants at risk
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Endocrine disorders
Hypothyroidism
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
11.4%
4/35 • Number of events 4 • Up to 2 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
2/35 • Number of events 2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Psychiatric disorders
Depression
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
Other adverse events
| Measure |
Treatment (Pazopanib Hydrochloride)
n=35 participants at risk
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.6%
3/35 • Number of events 5 • Up to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
11.4%
4/35 • Number of events 7 • Up to 2 years
|
|
Eye disorders
Blurred vision
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Eye disorders
Dry eye
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Eye disorders
Watering eyes
|
2.9%
1/35 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
17.1%
6/35 • Number of events 7 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
65.7%
23/35 • Number of events 95 • Up to 2 years
|
|
Gastrointestinal disorders
Esophageal pain
|
2.9%
1/35 • Number of events 3 • Up to 2 years
|
|
Gastrointestinal disorders
Flatulence
|
5.7%
2/35 • Number of events 4 • Up to 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Gastroparesis
|
2.9%
1/35 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
25.7%
9/35 • Number of events 20 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
17.1%
6/35 • Number of events 8 • Up to 2 years
|
|
General disorders
Edema limbs
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
General disorders
Fatigue
|
88.6%
31/35 • Number of events 190 • Up to 2 years
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
2.9%
1/35 • Number of events 2 • Up to 2 years
|
|
General disorders
Pain
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
65.7%
23/35 • Number of events 69 • Up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
5.7%
2/35 • Number of events 2 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
51.4%
18/35 • Number of events 44 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
14.3%
5/35 • Number of events 11 • Up to 2 years
|
|
Investigations
CD4 lymphocytes decreased
|
5.7%
2/35 • Number of events 2 • Up to 2 years
|
|
Investigations
Creatinine increased
|
8.6%
3/35 • Number of events 7 • Up to 2 years
|
|
Investigations
Ejection fraction decreased
|
5.7%
2/35 • Number of events 2 • Up to 2 years
|
|
Investigations
INR increased
|
2.9%
1/35 • Number of events 3 • Up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
14.3%
5/35 • Number of events 13 • Up to 2 years
|
|
Investigations
Neutrophil count decreased
|
11.4%
4/35 • Number of events 6 • Up to 2 years
|
|
Investigations
Platelet count decreased
|
8.6%
3/35 • Number of events 15 • Up to 2 years
|
|
Investigations
Weight loss
|
8.6%
3/35 • Number of events 15 • Up to 2 years
|
|
Investigations
White blood cell decreased
|
20.0%
7/35 • Number of events 11 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
17.1%
6/35 • Number of events 20 • Up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.7%
2/35 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.7%
2/35 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.3%
5/35 • Number of events 8 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.6%
10/35 • Number of events 17 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.3%
5/35 • Number of events 9 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
2/35 • Number of events 4 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.9%
1/35 • Number of events 2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
14.3%
5/35 • Number of events 26 • Up to 2 years
|
|
Nervous system disorders
Headache
|
5.7%
2/35 • Number of events 3 • Up to 2 years
|
|
Nervous system disorders
Paresthesia
|
2.9%
1/35 • Number of events 3 • Up to 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
11.4%
4/35 • Number of events 21 • Up to 2 years
|
|
Renal and urinary disorders
Proteinuria
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.9%
1/35 • Number of events 2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.6%
3/35 • Number of events 12 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
2.9%
1/35 • Number of events 2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.6%
3/35 • Number of events 3 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
11.4%
4/35 • Number of events 15 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.9%
1/35 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
5.7%
2/35 • Number of events 8 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
80.0%
28/35 • Number of events 149 • Up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place