Pazopanib Versus Sunitinib in the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma
Study Details
Study Description
Brief Summary
This study is being conducted to provide a direct comparison of the efficacy, safety, and tolerabilityfor pazopanib and sunitinib (SUTENT) in the Asian population.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
The study is designed to evaluate efficacy and safety of pazopanib versus sunitinib for the treatment of Asian subjects with locally advanced and/or metastatic renal cell carcinoma (RCC) enrolled from selected Far-East Asian countries. The primary objective is to evaluate the primary endpoint progression free survival in the enrolled Asian subjects treated with pazopanib versus those treated with sunitinib. The secondary objectives are to evaluate the following secondary endpoints in each treatment arm: objective response rate, duration of response, time to response, overall survival and safety. Subjects will be randomized in a 1:1 ratio to receive either 800mg pazopanib to be administered once daily orally continuous dosing or 50mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment. Subjects are permitted to receive supportive care throughout the study including transfusion of blood and blood products, treatment with antibiotics, anti-emetics, anti-diarrheal agents, analgesics, erythropoietin, or bisphosphonates, when appropriate. The study treatment will continue until subjects experience disease progression, unacceptable toxicity, withdraw consent, or death.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Pazopanib 800 mg administered once daily orally continuous dosing |
Drug: Pazopanib
800 mg administered once daily orally continuous dosing
|
Active Comparator: Sunitinib 50 mg sunitinib to be administered in 6-week cycles: 50 mg orally daily for 4 weeks followed by 2 weeks off treatment |
Drug: Sunitinib
50 mg sunitinib to be administered in 6-week cycle: 50 mg orally daily for 4 weeks followed by 2 weeks off treatment
|
Outcome Measures
Primary Outcome Measures
- Progression-free Survival (PFS) [From randomization to the earliest date of disease progression or death (up to 39 months)]
PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter (LD) recorded since the treatment started or the appearance of >=1 new lesion. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.
Secondary Outcome Measures
- Overall Survival (OS) [From randomization until death (up to 44 months)]
OS is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.
- Number of Participants With a Best Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the IRC [From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)]
The number of participants with evidence of CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters [mm] in the short axis) or PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD) was evaluated by an independent review per RECIST, Version 1.
- Time to Response [From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)]
Time to response is defined as the time from the start of treatment until the first documented evidence of confirmed CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1.
- Duration of Response (DOR) [From the time of response until the earliest date of disease progression/death (up to 38 months)]
DOR is defined as the time from the first documented evidence of confirmed response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Written informed consent
-
Diagnosis of renal cell carcinoma with clear-cell component histology.
-
Received no prior systemic therapy (interleukin-2, interferon-alpha, chemotherapy, bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic RCC
-
Locally advanced or metastatic renal cell carcinoma Measurable disease by CT or MRI
-
Karnofsky performance scale status of >=70
-
Age >=18 years
-
A female is eligible to enter and participate in this study if she is of: non-childbearing or agrees to use adequate contraception.
-
Adequate organ system function
-
Total serum calcium concentration <12.0mg/dL
-
Left ventricular ejection fraction >= lower limit of institutional normal
Exclusion Criteria:
-
Pregnant or lactating female (unless agrees to refrain from nursing throughout the treatment period and for 14 days following the last dose of study)-History of another malignancy (unless have been disease-free for 3 years)
-
History or clinical evidence of central nervous system (CNS) metastases (unless have previously-treated CNS metastases and meet all 3 of the following criteria are: are asymptomatic, have had no evidence of active CNS metastases for >=6 months prior to enrolment, and have no requirement for steroids or enzyme-inducing anticonvulsants)
-
Clinically significant gastrointestinal abnormalities including, but not limited to: malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, known intraluminal metastatic lesion/s with suspected bleeding, Inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
-
Presence of uncontrolled infection
-
Prolongation of corrected QT interval (QTc) > 480 milliseconds
-
History of any one or more of the following cardiovascular conditions within the past 12 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association
-
History of cerebrovascular accident including transient ischemic attack within the past 12 months
-
History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months (unless had recent DVT and have been treated with therapeutic anti-coagulating agents for at least 6 weeks)
-
Poorly controlled hypertension (defined as systolic blood pressure of >=150mmHg or diastolic blood pressure of >=90mmHg). Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry
-
Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
-
Evidence of active bleeding or bleeding susceptibility
-
Spitting/coughing up blood within 6 weeks of first dose of study drug
-
Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
-
Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study
-
Use any prohibited medications within 14 days of the first dose of study medication
-
Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug
-
Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors (eg. bevacizumab, sunitinib, sorafenib, etc), or are mTOR inhibitors (eg. temsirolimus, everolimus, etc).
-
Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy (surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy)
-
Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity
-
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or sunitinib
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Novartis Investigative Site | Guangzhou | Guangdong | China | 510060 |
2 | Novartis Investigative Site | Nanjing | Jiangsu | China | 210002 |
3 | Novartis Investigative Site | Hangzhou | Zhejiang | China | 310003 |
4 | Novartis Investigative Site | Beijing | China | 100021 | |
5 | Novartis Investigative Site | Beijing | China | 100036 | |
6 | Novartis Investigative Site | Beijing | China | 100853 | |
7 | Novartis Investigative Site | Beijing | China | ||
8 | Novartis Investigative Site | Shanghai | China | 200032 | |
9 | Novartis Investigative Site | Shanghai | China | 200127 | |
10 | Novartis Investigative Site | Tianjin | China | 300060 | |
11 | Novartis Investigative Site | Daejeon | Korea, Republic of | 301-721 | |
12 | Novartis Investigative Site | Goyang-si, Gyeonggi-Do | Korea, Republic of | 410-769 | |
13 | Novartis Investigative Site | Seoul | Korea, Republic of | 120-752 | |
14 | Novartis Investigative Site | Seoul | Korea, Republic of | 135-710 | |
15 | Novartis Investigative Site | Seoul | Korea, Republic of | 138-736 | |
16 | Novartis Investigative Site | Kaohsiung Hsien | Taiwan | 833 | |
17 | Novartis Investigative Site | Taichung | Taiwan | 40402 | |
18 | Novartis Investigative Site | Taichung | Taiwan | 40705 | |
19 | Novartis Investigative Site | Taipei | Taiwan | 10002 | |
20 | Novartis Investigative Site | Taipei | Taiwan | 11217 | |
21 | Novartis Investigative Site | Taoyuan County | Taiwan | 333 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 113078
- CPZP034A2201
Study Results
Participant Flow
Recruitment Details | Study VEG113078 is a substudy of Study VEG108844 (NCT00720941). Due to the projected limited enrollment of Asian participants into Study VEG108844, Study VEG113078 was designed to evaluate the efficacy and safety of pazopanib versus sunitinib for the treatment of Asian participants (par.) enrolled from selected Far-East Asian countries. |
---|---|
Pre-assignment Detail | Par. from China, Korea, and Taiwan who enrolled in either Study VEG108844 or VEG113078 and par. from Japan who enrolled in Study VEG108844 were pooled for analysis of the Asian population, presented in this report. Only 183 participants were enrolled in Study VEG113078 (as reflected in the Enrollment field in the Protocol record). |
Arm/Group Title | Pazopanib 800 mg | Sunitinib 50 mg |
---|---|---|
Arm/Group Description | Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. | Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. |
Period Title: Overall Study | ||
STARTED | 188 | 179 |
Not Completed/Ongoing | 111 | 102 |
COMPLETED | 0 | 0 |
NOT COMPLETED | 188 | 179 |
Baseline Characteristics
Arm/Group Title | Pazopanib 800 mg | Sunitinib 50 mg | Total |
---|---|---|---|
Arm/Group Description | Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. | Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. | Total of all reporting groups |
Overall Participants | 188 | 179 | 367 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
57.7
(11.51)
|
57.6
(11.19)
|
57.6
(11.34)
|
Sex: Female, Male (Count of Participants) | |||
Female |
51
27.1%
|
42
23.5%
|
93
25.3%
|
Male |
137
72.9%
|
137
76.5%
|
274
74.7%
|
Race/Ethnicity, Customized (Number) [Number] | |||
Asian - Central/South Asian Heritage |
2
1.1%
|
1
0.6%
|
3
0.8%
|
Asian - East Asian Heritage |
154
81.9%
|
144
80.4%
|
298
81.2%
|
Asian - Japanese Heritage |
29
15.4%
|
31
17.3%
|
60
16.3%
|
Asian - South East Asian Heritage |
3
1.6%
|
3
1.7%
|
6
1.6%
|
Outcome Measures
Title | Progression-free Survival (PFS) |
---|---|
Description | PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter (LD) recorded since the treatment started or the appearance of >=1 new lesion. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off. |
Time Frame | From randomization to the earliest date of disease progression or death (up to 39 months) |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-Treat (ITT) Population (Asian): All randomized participants (par) from Study VEG113078 and Study VEG108844 who enrolled in Japan, China, Taiwan, and Korea. |
Arm/Group Title | Pazopanib 800 mg | Sunitinib 50 mg |
---|---|---|
Arm/Group Description | Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. | Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. |
Measure Participants | 188 | 179 |
Median (95% Confidence Interval) [Months] |
8.4
|
11.1
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Pazopanib 800 mg, Sunitinib 50 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.0184 | |
Confidence Interval |
(2-Sided) 95% 0.7658 to 1.3542 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | The HR was estimated by the Cox regression model using treatment stratification factors as covariates. The HR was adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase. |
Title | Overall Survival (OS) |
---|---|
Description | OS is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off. |
Time Frame | From randomization until death (up to 44 months) |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population (Asian) |
Arm/Group Title | Pazopanib 800 mg | Sunitinib 50 mg |
---|---|---|
Arm/Group Description | Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. | Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. |
Measure Participants | 188 | 179 |
Median (95% Confidence Interval) [Months] |
NA
|
31.5
|
Title | Number of Participants With a Best Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the IRC |
---|---|
Description | The number of participants with evidence of CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters [mm] in the short axis) or PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD) was evaluated by an independent review per RECIST, Version 1. |
Time Frame | From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months) |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population (Asian) |
Arm/Group Title | Pazopanib 800 mg | Sunitinib 50 mg |
---|---|---|
Arm/Group Description | Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. | Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. |
Measure Participants | 188 | 179 |
Complete Response |
1
0.5%
|
0
0%
|
Partial Response |
66
35.1%
|
37
20.7%
|
Title | Time to Response |
---|---|
Description | Time to response is defined as the time from the start of treatment until the first documented evidence of confirmed CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1. |
Time Frame | From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months) |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population (Asian). Only those participants who experienced either a confirmed CR or a PR were analyzed. |
Arm/Group Title | Pazopanib 800 mg | Sunitinib 50 mg |
---|---|---|
Arm/Group Description | Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. | Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. |
Measure Participants | 67 | 37 |
Median (95% Confidence Interval) [Weeks] |
11.9
|
17.9
|
Title | Duration of Response (DOR) |
---|---|
Description | DOR is defined as the time from the first documented evidence of confirmed response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD. |
Time Frame | From the time of response until the earliest date of disease progression/death (up to 38 months) |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population (Asian). Only those participants who experienced either a confirmed CR or a PR were analyzed. |
Arm/Group Title | Pazopanib 800 mg | Sunitinib 50 mg |
---|---|---|
Arm/Group Description | Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. | Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. |
Measure Participants | 67 | 37 |
Median (95% Confidence Interval) [Months] |
15.2
|
18.0
|
Adverse Events
Time Frame | Participants were analyzed from the first dose of study medication until the follow-up contact (up to Study Week 156). | |||
---|---|---|---|---|
Adverse Event Reporting Description | Serious adverse events (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication, according to the actual treatment received. | |||
Arm/Group Title | Pazopanib 800 mg | Sunitinib 50 mg | ||
Arm/Group Description | Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. | Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. | ||
All Cause Mortality |
||||
Pazopanib 800 mg | Sunitinib 50 mg | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Pazopanib 800 mg | Sunitinib 50 mg | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 68/186 (36.6%) | 73/177 (41.2%) | ||
Blood and lymphatic system disorders | ||||
Anemia | 4/186 (2.2%) | 4/177 (2.3%) | ||
Febrile neutropenia | 2/186 (1.1%) | 0/177 (0%) | ||
Thrombocytopenia | 2/186 (1.1%) | 15/177 (8.5%) | ||
Neutropenia | 1/186 (0.5%) | 5/177 (2.8%) | ||
Lymphopenia | 0/186 (0%) | 1/177 (0.6%) | ||
Cardiac disorders | ||||
Cardiac failure congestive | 1/186 (0.5%) | 0/177 (0%) | ||
Cardiopulmonary failure | 1/186 (0.5%) | 0/177 (0%) | ||
Angina unstable | 0/186 (0%) | 1/177 (0.6%) | ||
Ear and labyrinth disorders | ||||
Sudden hearing loss | 0/186 (0%) | 1/177 (0.6%) | ||
Gastrointestinal disorders | ||||
Diarrhea | 2/186 (1.1%) | 1/177 (0.6%) | ||
Ileus | 2/186 (1.1%) | 0/177 (0%) | ||
Anal fistula | 1/186 (0.5%) | 0/177 (0%) | ||
Ascites | 1/186 (0.5%) | 0/177 (0%) | ||
Colonic polyp | 1/186 (0.5%) | 0/177 (0%) | ||
Duodenal ulcer | 1/186 (0.5%) | 0/177 (0%) | ||
Enterocolitis | 1/186 (0.5%) | 0/177 (0%) | ||
Gastritis erosive | 1/186 (0.5%) | 0/177 (0%) | ||
Lower gastrointestinal hemorrhage | 1/186 (0.5%) | 0/177 (0%) | ||
Nausea | 1/186 (0.5%) | 0/177 (0%) | ||
Small intestinal hemorrhage | 1/186 (0.5%) | 0/177 (0%) | ||
Upper gastrointestinal hemorrhage | 1/186 (0.5%) | 2/177 (1.1%) | ||
Vomiting | 1/186 (0.5%) | 0/177 (0%) | ||
Abdominal distension | 0/186 (0%) | 1/177 (0.6%) | ||
Gastritis | 0/186 (0%) | 1/177 (0.6%) | ||
Gastrointestinal hemorrhage | 0/186 (0%) | 1/177 (0.6%) | ||
Pancreatitis acute | 0/186 (0%) | 1/177 (0.6%) | ||
General disorders | ||||
Pyrexia | 3/186 (1.6%) | 7/177 (4%) | ||
Disease progression | 1/186 (0.5%) | 0/177 (0%) | ||
Fatigue | 1/186 (0.5%) | 4/177 (2.3%) | ||
Pain | 1/186 (0.5%) | 0/177 (0%) | ||
Asthenia | 0/186 (0%) | 2/177 (1.1%) | ||
Hepatobiliary disorders | ||||
Hepatic function abnormal | 6/186 (3.2%) | 3/177 (1.7%) | ||
Cholecystitis acute | 1/186 (0.5%) | 0/177 (0%) | ||
Drug-induced liver injury | 1/186 (0.5%) | 1/177 (0.6%) | ||
Cholecystitis | 0/186 (0%) | 1/177 (0.6%) | ||
Hepatitis | 0/186 (0%) | 1/177 (0.6%) | ||
Hyperbilirubinemia | 0/186 (0%) | 2/177 (1.1%) | ||
Infections and infestations | ||||
Pneumonia | 2/186 (1.1%) | 1/177 (0.6%) | ||
Appendicitis | 1/186 (0.5%) | 1/177 (0.6%) | ||
Cellulitis | 1/186 (0.5%) | 0/177 (0%) | ||
H1N1 influenza | 1/186 (0.5%) | 0/177 (0%) | ||
Infection | 1/186 (0.5%) | 0/177 (0%) | ||
Lung infection | 1/186 (0.5%) | 0/177 (0%) | ||
Septic shock | 1/186 (0.5%) | 0/177 (0%) | ||
Gastroenteritis | 0/186 (0%) | 1/177 (0.6%) | ||
Herpes zoster | 0/186 (0%) | 1/177 (0.6%) | ||
Perinephric abscess | 0/186 (0%) | 1/177 (0.6%) | ||
Peritonitis | 0/186 (0%) | 1/177 (0.6%) | ||
Pneumonia bacterial | 0/186 (0%) | 1/177 (0.6%) | ||
Retroperitoneal abscess | 0/186 (0%) | 1/177 (0.6%) | ||
Injury, poisoning and procedural complications | ||||
Brain herniation | 1/186 (0.5%) | 0/177 (0%) | ||
Contusion | 1/186 (0.5%) | 0/177 (0%) | ||
Fracture | 0/186 (0%) | 1/177 (0.6%) | ||
Patella fracture | 0/186 (0%) | 1/177 (0.6%) | ||
Investigations | ||||
Alanine aminotransferase increased | 11/186 (5.9%) | 3/177 (1.7%) | ||
Aspartate aminotransferase increased | 4/186 (2.2%) | 0/177 (0%) | ||
Lipase increased | 4/186 (2.2%) | 3/177 (1.7%) | ||
Neutrophil count decreased | 2/186 (1.1%) | 0/177 (0%) | ||
Blood bilirubin increased | 1/186 (0.5%) | 1/177 (0.6%) | ||
Blood glucose decreased | 1/186 (0.5%) | 0/177 (0%) | ||
Blood potassium increased | 1/186 (0.5%) | 0/177 (0%) | ||
Gamma-glutamyltransferase increased | 1/186 (0.5%) | 0/177 (0%) | ||
Liver function test abnormal | 1/186 (0.5%) | 0/177 (0%) | ||
Amylase increased | 0/186 (0%) | 1/177 (0.6%) | ||
Blood calcium increased | 0/186 (0%) | 1/177 (0.6%) | ||
Blood creatine phosphokinase increased | 0/186 (0%) | 1/177 (0.6%) | ||
Blood magnesium decreased | 0/186 (0%) | 1/177 (0.6%) | ||
Platelet count decreased | 0/186 (0%) | 7/177 (4%) | ||
Metabolism and nutrition disorders | ||||
Hyponatremia | 3/186 (1.6%) | 2/177 (1.1%) | ||
Decreased appetite | 2/186 (1.1%) | 0/177 (0%) | ||
Hypercalcemia | 1/186 (0.5%) | 0/177 (0%) | ||
Hyperlipasemia | 1/186 (0.5%) | 0/177 (0%) | ||
Hyperuricemia | 1/186 (0.5%) | 2/177 (1.1%) | ||
Hypocalcemia | 1/186 (0.5%) | 0/177 (0%) | ||
Hyperkalemia | 0/186 (0%) | 1/177 (0.6%) | ||
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 1/186 (0.5%) | 0/177 (0%) | ||
Back pain | 1/186 (0.5%) | 2/177 (1.1%) | ||
Bone pain | 1/186 (0.5%) | 0/177 (0%) | ||
Flank pain | 1/186 (0.5%) | 1/177 (0.6%) | ||
Pain in extremity | 1/186 (0.5%) | 1/177 (0.6%) | ||
Fistula | 0/186 (0%) | 1/177 (0.6%) | ||
Musculoskeletal pain | 0/186 (0%) | 1/177 (0.6%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Colon cancer | 2/186 (1.1%) | 0/177 (0%) | ||
Cancer pain | 1/186 (0.5%) | 0/177 (0%) | ||
Metastases to central nervous system | 1/186 (0.5%) | 0/177 (0%) | ||
Tumour rupture | 1/186 (0.5%) | 0/177 (0%) | ||
Gastric cancer | 0/186 (0%) | 1/177 (0.6%) | ||
Tumour hemorrhage | 0/186 (0%) | 1/177 (0.6%) | ||
Nervous system disorders | ||||
Cerebral hemorrhage | 1/186 (0.5%) | 0/177 (0%) | ||
Hemorrhage intracranial | 1/186 (0.5%) | 0/177 (0%) | ||
Subarachnoid hemorrhage | 0/186 (0%) | 1/177 (0.6%) | ||
Syncope | 0/186 (0%) | 1/177 (0.6%) | ||
Tremor | 0/186 (0%) | 1/177 (0.6%) | ||
Central nervous system hemorrhage | 0/186 (0%) | 1/177 (0.6%) | ||
Cerebral infarction | 0/186 (0%) | 1/177 (0.6%) | ||
Hemorrhagic cerebral infarction | 0/186 (0%) | 1/177 (0.6%) | ||
Psychiatric disorders | ||||
Mental status changes | 1/186 (0.5%) | 0/177 (0%) | ||
Renal and urinary disorders | ||||
Hematuria | 0/186 (0%) | 1/177 (0.6%) | ||
Renal failure | 0/186 (0%) | 1/177 (0.6%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Pleuritic pain | 1/186 (0.5%) | 0/177 (0%) | ||
Pulmonary embolism | 1/186 (0.5%) | 0/177 (0%) | ||
Respiratory failure | 1/186 (0.5%) | 2/177 (1.1%) | ||
Hiccups | 0/186 (0%) | 1/177 (0.6%) | ||
Laryngeal hemorrhage | 0/186 (0%) | 1/177 (0.6%) | ||
Pleural effusion | 0/186 (0%) | 4/177 (2.3%) | ||
Pneumonia aspiration | 0/186 (0%) | 1/177 (0.6%) | ||
Pneumonitis | 0/186 (0%) | 1/177 (0.6%) | ||
Pneumothorax | 0/186 (0%) | 1/177 (0.6%) | ||
Pulmonary artery thrombosis | 0/186 (0%) | 1/177 (0.6%) | ||
Vascular disorders | ||||
Deep vein thrombosis | 1/186 (0.5%) | 0/177 (0%) | ||
Hypertension | 1/186 (0.5%) | 2/177 (1.1%) | ||
Arterial rupture | 0/186 (0%) | 1/177 (0.6%) | ||
Other (Not Including Serious) Adverse Events |
||||
Pazopanib 800 mg | Sunitinib 50 mg | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 182/186 (97.8%) | 173/177 (97.7%) | ||
Blood and lymphatic system disorders | ||||
Neutropenia | 43/186 (23.1%) | 75/177 (42.4%) | ||
Leukopenia | 40/186 (21.5%) | 59/177 (33.3%) | ||
Thrombocytopenia | 29/186 (15.6%) | 79/177 (44.6%) | ||
Anemia | 10/186 (5.4%) | 48/177 (27.1%) | ||
Lymphopenia | 3/186 (1.6%) | 11/177 (6.2%) | ||
Endocrine disorders | ||||
Hypothyroidism | 29/186 (15.6%) | 50/177 (28.2%) | ||
Hyperthyroidism | 3/186 (1.6%) | 11/177 (6.2%) | ||
Eye disorders | ||||
Eyelid oedema | 17/186 (9.1%) | 29/177 (16.4%) | ||
Gastrointestinal disorders | ||||
Diarrhea | 100/186 (53.8%) | 81/177 (45.8%) | ||
Nausea | 44/186 (23.7%) | 40/177 (22.6%) | ||
Vomiting | 39/186 (21%) | 26/177 (14.7%) | ||
Abdominal pain upper | 29/186 (15.6%) | 21/177 (11.9%) | ||
Stomatitis | 25/186 (13.4%) | 53/177 (29.9%) | ||
Abdominal pain | 18/186 (9.7%) | 15/177 (8.5%) | ||
Dyspepsia | 18/186 (9.7%) | 23/177 (13%) | ||
Mouth ulceration | 17/186 (9.1%) | 27/177 (15.3%) | ||
Constipation | 14/186 (7.5%) | 31/177 (17.5%) | ||
Abdominal discomfort | 12/186 (6.5%) | 16/177 (9%) | ||
Gingivitis | 12/186 (6.5%) | 8/177 (4.5%) | ||
Abdominal distension | 10/186 (5.4%) | 10/177 (5.6%) | ||
Gingival bleeding | 6/186 (3.2%) | 9/177 (5.1%) | ||
Toothache | 5/186 (2.7%) | 9/177 (5.1%) | ||
General disorders | ||||
Fatigue | 78/186 (41.9%) | 89/177 (50.3%) | ||
Pyrexia | 18/186 (9.7%) | 25/177 (14.1%) | ||
Mucosal inflammation | 12/186 (6.5%) | 20/177 (11.3%) | ||
Oedema peripheral | 12/186 (6.5%) | 20/177 (11.3%) | ||
Oedema | 8/186 (4.3%) | 17/177 (9.6%) | ||
Face oedema | 7/186 (3.8%) | 32/177 (18.1%) | ||
Hepatobiliary disorders | ||||
Hyperbilirubinaemia | 17/186 (9.1%) | 10/177 (5.6%) | ||
Infections and infestations | ||||
Nasopharyngitis | 15/186 (8.1%) | 19/177 (10.7%) | ||
Upper respiratory tract infection | 9/186 (4.8%) | 11/177 (6.2%) | ||
Investigations | ||||
Aspartate aminotransferase increased | 74/186 (39.8%) | 59/177 (33.3%) | ||
Alanine aminotransferase increased | 71/186 (38.2%) | 55/177 (31.1%) | ||
Blood bilirubin increased | 34/186 (18.3%) | 26/177 (14.7%) | ||
Blood creatinine increased | 31/186 (16.7%) | 48/177 (27.1%) | ||
Platelet count decreased | 30/186 (16.1%) | 58/177 (32.8%) | ||
Blood lactate dehydrogenase increased | 26/186 (14%) | 43/177 (24.3%) | ||
Neutrophil count decreased | 25/186 (13.4%) | 47/177 (26.6%) | ||
White blood cell count decreased | 24/186 (12.9%) | 52/177 (29.4%) | ||
Haemoglobin decreased | 21/186 (11.3%) | 48/177 (27.1%) | ||
Amylase increased | 20/186 (10.8%) | 13/177 (7.3%) | ||
Lipase increased | 20/186 (10.8%) | 18/177 (10.2%) | ||
Blood alkaline phosphatase increased | 19/186 (10.2%) | 12/177 (6.8%) | ||
Bilirubin conjugated increased | 17/186 (9.1%) | 6/177 (3.4%) | ||
Blood thyroid stimulating hormone increased | 17/186 (9.1%) | 32/177 (18.1%) | ||
Blood triglycerides increased | 17/186 (9.1%) | 22/177 (12.4%) | ||
Gamma-glutamyltransferase increased | 17/186 (9.1%) | 6/177 (3.4%) | ||
Weight decreased | 17/186 (9.1%) | 5/177 (2.8%) | ||
Blood bilirubin unconjugated increased | 16/186 (8.6%) | 8/177 (4.5%) | ||
Blood albumin decreased | 12/186 (6.5%) | 14/177 (7.9%) | ||
Blood urea increased | 9/186 (4.8%) | 12/177 (6.8%) | ||
Blood glucose increased | 8/186 (4.3%) | 10/177 (5.6%) | ||
Blood phosphorus decreased | 8/186 (4.3%) | 11/177 (6.2%) | ||
Haematocrit decreased | 6/186 (3.2%) | 12/177 (6.8%) | ||
Red blood cell count decreased | 2/186 (1.1%) | 9/177 (5.1%) | ||
Xanthochromia | 1/186 (0.5%) | 10/177 (5.6%) | ||
Metabolism and nutrition disorders | ||||
Decreased appetite | 77/186 (41.4%) | 66/177 (37.3%) | ||
Hyponatremia | 11/186 (5.9%) | 16/177 (9%) | ||
Hypophosphatemia | 11/186 (5.9%) | 16/177 (9%) | ||
Hyperglycemia | 8/186 (4.3%) | 15/177 (8.5%) | ||
Hypoalbuminemia | 4/186 (2.2%) | 11/177 (6.2%) | ||
Hypocalcemia | 2/186 (1.1%) | 11/177 (6.2%) | ||
Hyperuricemia | 0/186 (0%) | 9/177 (5.1%) | ||
Musculoskeletal and connective tissue disorders | ||||
Back pain | 21/186 (11.3%) | 17/177 (9.6%) | ||
Myalgia | 14/186 (7.5%) | 12/177 (6.8%) | ||
Arthralgia | 13/186 (7%) | 10/177 (5.6%) | ||
Pain in extremity | 13/186 (7%) | 18/177 (10.2%) | ||
Flank pain | 0/186 (0%) | 9/177 (5.1%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Hypogeusia | 9/186 (4.8%) | 12/177 (6.8%) | ||
Nervous system disorders | ||||
Headache | 27/186 (14.5%) | 20/177 (11.3%) | ||
Dysgeusia | 25/186 (13.4%) | 37/177 (20.9%) | ||
Dizziness | 16/186 (8.6%) | 17/177 (9.6%) | ||
Psychiatric disorders | ||||
Insomnia | 10/186 (5.4%) | 14/177 (7.9%) | ||
Renal and urinary disorders | ||||
Proteinuria | 60/186 (32.3%) | 53/177 (29.9%) | ||
Haematuria | 8/186 (4.3%) | 10/177 (5.6%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 20/186 (10.8%) | 23/177 (13%) | ||
Epistaxis | 14/186 (7.5%) | 27/177 (15.3%) | ||
Dysphonia | 13/186 (7%) | 4/177 (2.3%) | ||
Oropharyngeal pain | 11/186 (5.9%) | 14/177 (7.9%) | ||
Dyspnoea | 8/186 (4.3%) | 19/177 (10.7%) | ||
Skin and subcutaneous tissue disorders | ||||
Palmar-plantar erythrodysaesthesia syndrome | 93/186 (50%) | 114/177 (64.4%) | ||
Hair colour changes | 67/186 (36%) | 14/177 (7.9%) | ||
Rash | 27/186 (14.5%) | 35/177 (19.8%) | ||
Alopecia | 23/186 (12.4%) | 11/177 (6.2%) | ||
Skin hypopigmentation | 16/186 (8.6%) | 4/177 (2.3%) | ||
Pruritus | 4/186 (2.2%) | 16/177 (9%) | ||
Yellow skin | 4/186 (2.2%) | 43/177 (24.3%) | ||
Vascular disorders | ||||
Hypertension | 103/186 (55.4%) | 94/177 (53.1%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Name/Title | Clinical Disclosure Office |
---|---|
Organization | Novartis Pharmaceuticals |
Phone | 862-778-8300 |
- 113078
- CPZP034A2201