Trial Outcomes & Findings for Phase II Pazopanib in Combination With Weekly Paclitaxel in Refractory Urothelial Cancer (NCT NCT01108055)
NCT ID: NCT01108055
Last Updated: 2017-06-09
Results Overview
The tumor response rate was assessed per the Response Evaluation Criteria In Solid Tumors (RECIST). RECIST criteria are a set of published rules that define when cancer patients improve ("respond"); stay the same ("stable"); or worsen ("progression") during treatments. RECIST criteria offer a simplified and conservative extraction of imaging data suitable for wide application in clinical trials. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories: * Complete response (CR) = Disappearance of all target lesions * Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions * Stable disease (SD) = Small changes that do not meet above criteria Objective tumor response means those with response better than stable disease, ie, complete response (CR) + partial response (PR).
COMPLETED
PHASE2
43 participants
Every 8 weeks
2017-06-09
Participant Flow
Participant milestones
| Measure |
Pazopanib + Paclitaxel
A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
Eligible and Started Treatment
|
32
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Pazopanib + Paclitaxel
A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
|
|---|---|
|
Overall Study
Ineligible
|
11
|
|
Overall Study
Not evaluable- didn't complete treatment
|
4
|
Baseline Characteristics
Phase II Pazopanib in Combination With Weekly Paclitaxel in Refractory Urothelial Cancer
Baseline characteristics by cohort
| Measure |
Pazopanib + Paclitaxel
n=32 Participants
A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
|
|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 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
|
4 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
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Prior Treatment Cycles
|
4 Cycles
n=5 Participants
|
|
Sites of Primary Tumor
Bladder
|
15 Participants
n=5 Participants
|
|
Sites of Primary Tumor
Renal Pelvis
|
11 Participants
n=5 Participants
|
|
Sites of Primary Tumor
Ureter
|
6 Participants
n=5 Participants
|
|
Number of prior chemotherapies
1
|
13 Participants
n=5 Participants
|
|
Number of prior chemotherapies
2
|
19 Participants
n=5 Participants
|
|
Time from last chemotherapy
< 3 months
|
15 Participants
n=5 Participants
|
|
Time from last chemotherapy
> 3 months
|
17 Participants
n=5 Participants
|
|
Bellmunt Score
0
|
7 Participants
n=5 Participants
|
|
Bellmunt Score
1
|
14 Participants
n=5 Participants
|
|
Bellmunt Score
2
|
11 Participants
n=5 Participants
|
|
Bellmunt Score
3
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 8 weeksPopulation: The outcome is reported as subjects with CR (complete response) + PR (partial response).
The tumor response rate was assessed per the Response Evaluation Criteria In Solid Tumors (RECIST). RECIST criteria are a set of published rules that define when cancer patients improve ("respond"); stay the same ("stable"); or worsen ("progression") during treatments. RECIST criteria offer a simplified and conservative extraction of imaging data suitable for wide application in clinical trials. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories: * Complete response (CR) = Disappearance of all target lesions * Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions * Stable disease (SD) = Small changes that do not meet above criteria Objective tumor response means those with response better than stable disease, ie, complete response (CR) + partial response (PR).
Outcome measures
| Measure |
Pazopanib + Paclitaxel
n=32 Participants
A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
|
|---|---|
|
Objective Tumor Response
|
15 Participants
|
SECONDARY outcome
Timeframe: 4 yearsOutcome measures
| Measure |
Pazopanib + Paclitaxel
n=32 Participants
A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
|
|---|---|
|
Progression-free Survival (PFS)
|
6.2 Months
Interval 5.6 to 7.6
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: Does not include participants who did not complete 2 cycles of treatment.
The tumor response rate was assessed per the Response Evaluation Criteria In Solid Tumors (RECIST). RECIST criteria are a set of published rules that define when cancer patients improve ("respond"); stay the same ("stable"); or worsen ("progression") during treatments. RECIST criteria offer a simplified and conservative extraction of imaging data suitable for wide application in clinical trials. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories: * Complete response (CR) = Disappearance of all target lesions * Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions * Stable disease (SD) = Small changes that do not meet above criteria Tumor response rate by each response criteria.
Outcome measures
| Measure |
Pazopanib + Paclitaxel
n=28 Participants
A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
|
|---|---|
|
Overall Response Rate
Complete Response (CR)
|
3 Participants
|
|
Overall Response Rate
Partial Response (PR)
|
12 Participants
|
|
Overall Response Rate
Stable Disease (SD)
|
11 Participants
|
|
Overall Response Rate
Progressive Disease (PD)
|
2 Participants
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: Does not include participants who did not complete 2 cycles of treatment.
Overall survival is reported as the median survival of the evaluable subjects (ie, completed 2 cycles of treatment).
Outcome measures
| Measure |
Pazopanib + Paclitaxel
n=28 Participants
A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
|
|---|---|
|
Overall Survival
|
10 Months
Interval 5.7 to 16.0
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: Include all 32 participants, regardless of completing 2 cycles of treatment.
Comparison between the participant's baseline Bellmunt prognostic risk factor score and survival rates. The Bellmunt prognostic risk factor score is a tool that is often used to predict treatment outcomes before initiating a secondline treatment regimen. The risk factors used to calculate the Bellmunt score include: * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 * Presence of liver metastases * Presence of visceral involvement (defined as liver, lung, bone or any non-lymph node) * Lymph node-only involvement * Hemoglobin concentration \< 10 g/dL The score is calculated based on the presence of 0; 1; 2; or 3 of the above prognostic factors. This outcome reports median overall survival based on whether the participant had 0; 1; 2; or 3 prognostic factors.
Outcome measures
| Measure |
Pazopanib + Paclitaxel
n=32 Participants
A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
|
|---|---|
|
Median Overall Survival (OS) by Bellmunt Score
Bellmunt Score of 0
|
13.8 Months
Interval 6.0 to 24.0
|
|
Median Overall Survival (OS) by Bellmunt Score
Bellmunt Score of 1
|
8 Months
Interval 2.0 to 55.0
|
|
Median Overall Survival (OS) by Bellmunt Score
Bellmunt Score of 2
|
7.7 Months
Interval 1.0 to 21.0
|
Adverse Events
Pazopanib + Paclitaxel
Serious adverse events
| Measure |
Pazopanib + Paclitaxel
n=32 participants at risk
A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
|
|---|---|
|
Investigations
electrolyte imbalance
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
wound complication, non infectious
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
gastrointestinal fistula
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
febrile neutropenia
|
6.2%
2/32 • Number of events 2
|
|
Infections and infestations
infection with grade 3 or 4 neutrophils
|
6.2%
2/32 • Number of events 2
|
|
General disorders
Fever
|
6.2%
2/32 • Number of events 2
|
|
Infections and infestations
bacterial pneumonia
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
infection with normal ANC
|
3.1%
1/32 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Cord compression
|
3.1%
1/32 • Number of events 1
|
|
Nervous system disorders
Seizure
|
3.1%
1/32 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
sepsis
|
3.1%
1/32 • Number of events 1
|
Other adverse events
| Measure |
Pazopanib + Paclitaxel
n=32 participants at risk
A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
|
|---|---|
|
General disorders
Fatigue
|
46.9%
15/32 • Number of events 35
|
|
Metabolism and nutrition disorders
Weight loss
|
12.5%
4/32 • Number of events 5
|
|
General disorders
Insomnia
|
6.2%
2/32 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
diaphoresis
|
6.2%
2/32 • Number of events 2
|
|
Infections and infestations
fever
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
anorexia
|
25.0%
8/32 • Number of events 9
|
|
Gastrointestinal disorders
diarrhea
|
15.6%
5/32 • Number of events 8
|
|
Gastrointestinal disorders
nausea
|
12.5%
4/32 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
4/32 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
9.4%
3/32 • Number of events 3
|
|
Gastrointestinal disorders
dysgeusia
|
9.4%
3/32 • Number of events 4
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
6.2%
2/32 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis/stomatitis - oral cavity
|
6.2%
2/32 • Number of events 2
|
|
Gastrointestinal disorders
salivary gland changes/saliva
|
6.2%
2/32 • Number of events 2
|
|
Gastrointestinal disorders
Dehydration
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
GI, other
|
3.1%
1/32 • Number of events 1
|
|
Blood and lymphatic system disorders
lukocytes
|
28.1%
9/32 • Number of events 12
|
|
Blood and lymphatic system disorders
Platelets
|
25.0%
8/32 • Number of events 16
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes
|
12.5%
4/32 • Number of events 8
|
|
Blood and lymphatic system disorders
anemia
|
18.8%
6/32 • Number of events 16
|
|
Blood and lymphatic system disorders
lymphopenia
|
18.8%
6/32 • Number of events 27
|
|
Blood and lymphatic system disorders
hemolysis
|
6.2%
2/32 • Number of events 2
|
|
General disorders
pain, back
|
18.8%
6/32 • Number of events 7
|
|
General disorders
Pain, abdomen NOS
|
15.6%
5/32 • Number of events 7
|
|
General disorders
Pain, head/headache
|
12.5%
4/32 • Number of events 4
|
|
General disorders
Pain, chest/thorax NOS
|
9.4%
3/32 • Number of events 3
|
|
General disorders
Pain Extremity-limb
|
6.2%
2/32 • Number of events 2
|
|
General disorders
Pain, chest wall
|
3.1%
1/32 • Number of events 1
|
|
General disorders
Pain, oral cavity
|
3.1%
1/32 • Number of events 1
|
|
Investigations
Creatinine, increased
|
21.9%
7/32 • Number of events 13
|
|
Investigations
Alt, SGPT
|
18.8%
6/32 • Number of events 8
|
|
Investigations
hyperglycemia
|
18.8%
6/32 • Number of events 9
|
|
Investigations
hypoalbuminemia
|
15.6%
5/32 • Number of events 7
|
|
Investigations
hypocalcemia
|
12.5%
4/32 • Number of events 8
|
|
Investigations
hypokalemia
|
12.5%
4/32 • Number of events 7
|
|
Investigations
alkaline phosphatase
|
9.4%
3/32 • Number of events 4
|
|
Investigations
hypomagnesemia
|
9.4%
3/32 • Number of events 3
|
|
Investigations
hyponatremia
|
9.4%
3/32 • Number of events 5
|
|
Investigations
hyperbilirubinemia
|
6.2%
2/32 • Number of events 2
|
|
Investigations
hyperkalemia
|
6.2%
2/32 • Number of events 4
|
|
Investigations
proteinuria
|
6.2%
2/32 • Number of events 2
|
|
Investigations
Bicarbonate, serum-low
|
3.1%
1/32 • Number of events 1
|
|
Investigations
Glomerular Filtration rate
|
3.1%
1/32 • Number of events 4
|
|
Investigations
hypophosphatemia
|
3.1%
1/32 • Number of events 1
|
|
Nervous system disorders
Neuropathy: sensory
|
21.9%
7/32 • Number of events 9
|
|
Nervous system disorders
Dizziness
|
15.6%
5/32 • Number of events 5
|
|
Nervous system disorders
Cognitive distrubance
|
3.1%
1/32 • Number of events 1
|
|
Nervous system disorders
memory impariment
|
3.1%
1/32 • Number of events 1
|
|
Nervous system disorders
Mood alteration - Anxeity
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.9%
7/32 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis/pulmonary infiltrates
|
6.2%
2/32 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary/upper respiratory
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia
|
12.5%
4/32 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
6.2%
2/32 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
6.2%
2/32 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
bruising (in absence of grade 3 or 4 thrombocytopenia)
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
hypopigmentation
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
injection site reaction/extravasation changes
|
3.1%
1/32 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC - Bladder
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC - Sinus
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
infection with unknown ANC - Urinary tract NOS
|
3.1%
1/32 • Number of events 1
|
|
General disorders
hemorrhage/bleeding
|
6.2%
2/32 • Number of events 5
|
|
Gastrointestinal disorders
hemorrhage, GI - Varices
|
3.1%
1/32 • Number of events 1
|
|
Renal and urinary disorders
hemorrhage, GU - bladder
|
3.1%
1/32 • Number of events 1
|
|
Renal and urinary disorders
Hemorrhage, GU - Urinary NOS
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
3.1%
1/32 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - other
|
6.2%
2/32 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
muscle weakness, extraocular
|
3.1%
1/32 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
muscle weakness, whole body/generalized
|
3.1%
1/32 • Number of events 1
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
9.4%
3/32 • Number of events 4
|
|
Vascular disorders
vascular - other
|
3.1%
1/32 • Number of events 1
|
|
Cardiac disorders
hypertension
|
9.4%
3/32 • Number of events 3
|
|
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in a monitoring program
|
3.1%
1/32 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
3.1%
1/32 • Number of events 1
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
3.1%
1/32 • Number of events 1
|
|
Blood and lymphatic system disorders
Edema: limb
|
3.1%
1/32 • Number of events 1
|
|
General disorders
growth and development- other
|
3.1%
1/32 • Number of events 1
|
|
Eye disorders
vision-flashing lights/floaters
|
3.1%
1/32 • Number of events 1
|
|
Reproductive system and breast disorders
gynecomastia
|
3.1%
1/32 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place