Trial Outcomes & Findings for Pazopanib in Treating Patients With Metastatic Urothelial Cancer (NCT NCT00471536)
NCT ID: NCT00471536
Last Updated: 2014-05-30
Results Overview
Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. Per RECIST v1.0 criteria: A Complete Response (CR) requires the disappearance of all target lesions. A Partial Response (PR) requires \>=30% decrease in the sum of the longest diameter of target lesions from baseline measurement. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.
COMPLETED
PHASE2
19 participants
Participants will be evaluated every 8 weeks during treatment and up to 1 year after completion of treatment.
2014-05-30
Participant Flow
Nineteen participants were accrued between October 2008 and December 2009.
Of the 19 participants accrued, one participant canceled prior to treatment evaluation, and therefore was excluded from toxicity analysis. This participant was included in the primary endpoint analysis.
Participant milestones
| Measure |
Treatment (Enzyme Inhibitor Therapy)
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Enzyme Inhibitor Therapy)
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Pazopanib in Treating Patients With Metastatic Urothelial Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=19 Participants
Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will be evaluated every 8 weeks during treatment and up to 1 year after completion of treatment.Population: All participants meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluated for response.
Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. Per RECIST v1.0 criteria: A Complete Response (CR) requires the disappearance of all target lesions. A Partial Response (PR) requires \>=30% decrease in the sum of the longest diameter of target lesions from baseline measurement. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=19 Participants
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Best Tumor Response (Complete [CR] or Partial Response [PR] by Response Evaluation Criteria in Solid Tumors [RECIST])
Partial Response (PR)
|
0 participants
|
|
Best Tumor Response (Complete [CR] or Partial Response [PR] by Response Evaluation Criteria in Solid Tumors [RECIST])
Complete Response (CR)
|
0 participants
|
SECONDARY outcome
Timeframe: Every 4 weeks during treatment (maximum duration was 44 weeks)Population: Eighteen of the 19 participants accrued to the study were evaluable for adverse events.
The maximum grade for each adverse event considered to be at least possibly related to treatment will be recorded. Frequency tables will be constructed.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=18 Participants
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Adverse Events Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Grade 3 Adverse Events
|
7 participants
|
|
Adverse Events Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Grade 4 or Higher Adverse Events
|
0 participants
|
SECONDARY outcome
Timeframe: Documented on 2 consecutive evaluations 8 weeks apart from the start of the treatment until disease progression/recurrence, assessed up to 1 yearTumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. A confirmed response is defined as a CR or PR and is documented on 2 consecutive evaluations.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=19 Participants
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Confirmed Tumor Response (CR and PR)
Confirmed Complete Response (CR)
|
0 participants
|
|
Confirmed Tumor Response (CR and PR)
Confirmed Partial Response (PR)
|
0 participants
|
SECONDARY outcome
Timeframe: From the time an objective response is first noted to be either a CR or PR to the date progression is documented, assessed up to 1 yearPopulation: There were no responses.
The distribution of response durations will be estimated using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 3 months from registration until progressive disease (PD), assessed up to 2 years after registrationPopulation: All participants were evaluable for this endpoint.
The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=19 Participants
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Time to Disease Progression
|
1.85 months
Interval 1.77 to 3.71
|
SECONDARY outcome
Timeframe: Time from registration until death due to any cause, assessed every 6 months after PD for up to 2 years after registrationPopulation: all participants were evaluable for this endpoint.
The distribution of survival times will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=19 Participants
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Survival Time
|
5.83 months
Interval 3.38 to 7.98
|
Adverse Events
Treatment (Enzyme Inhibitor Therapy)
Serious adverse events
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=18 participants at risk
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
5.6%
1/18 • Number of events 2
|
|
Gastrointestinal disorders
Oral hemorrhage
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Fatigue
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Creatinine increased
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Taste alteration
|
5.6%
1/18 • Number of events 1
|
|
Renal and urinary disorders
Ureteric stenosis
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
Hypertension
|
5.6%
1/18 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=18 participants at risk
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
72.2%
13/18 • Number of events 32
|
|
Eye disorders
Flashing vision
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
3/18 • Number of events 7
|
|
Gastrointestinal disorders
Anal pain
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
9/18 • Number of events 17
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
5.6%
1/18 • Number of events 3
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
5.6%
1/18 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
55.6%
10/18 • Number of events 23
|
|
Gastrointestinal disorders
Stomach pain
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
38.9%
7/18 • Number of events 12
|
|
General disorders
Fatigue
|
94.4%
17/18 • Number of events 53
|
|
Injury, poisoning and procedural complications
Fracture
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
Urostomy site bleeding
|
5.6%
1/18 • Number of events 5
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
22.2%
4/18 • Number of events 11
|
|
Investigations
Bilirubin increased
|
11.1%
2/18 • Number of events 2
|
|
Investigations
Leukocyte count decreased
|
44.4%
8/18 • Number of events 15
|
|
Investigations
Lymphocyte count decreased
|
11.1%
2/18 • Number of events 3
|
|
Investigations
Neutrophil count decreased
|
16.7%
3/18 • Number of events 6
|
|
Investigations
Platelet count decreased
|
55.6%
10/18 • Number of events 19
|
|
Investigations
Weight loss
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
44.4%
8/18 • Number of events 19
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
11.1%
2/18 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18 • Number of events 2
|
|
Nervous system disorders
Taste alteration
|
5.6%
1/18 • Number of events 1
|
|
Renal and urinary disorders
Bladder hemorrhage
|
5.6%
1/18 • Number of events 1
|
|
Renal and urinary disorders
Protein urine positive
|
38.9%
7/18 • Number of events 20
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
11.1%
2/18 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
5.6%
1/18 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
1/18 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
11.1%
2/18 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
5.6%
1/18 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
22.2%
4/18 • Number of events 9
|
|
Vascular disorders
Hypertension
|
50.0%
9/18 • Number of events 31
|
Additional Information
Ulka Vaishampayan, M.D.
Karmanos Cancer Institute at Wayne State University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60