A Phase 3 interventional study of pazopanib and sunitinib in Carcinoma, Renal Cell, sponsored by Novartis Pharmaceuticals. Completed at 51 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-17.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
This is a randomised, double-blind, cross-over study of pazopanib versus sunitinib in patients with locally advanced or metastatic renal cell carcinoma (mRCC) who have received no prior systemic therapy for advanced or metastatic RCC. Approximately 160 eligible patients will be stratified based on the ECOG performance status (0 vs. 1) and number of metastatic sites of disease (0 and 1 vs. >=2). The study consists of two treatment periods of 10 weeks with a 2-week wash-out period between the two treatment periods. Patients will receive pazopanib and sunitinib treatment sequentially in a double-blinded fashion. The primary objective of the study is to assess how the tolerability and safety differences between pazopanib and sunitinib translate into patient preference, defined by the patient's stated preference for which drug they may prefer to continue treatment with at end of study. The secondary objectives are to evaluate the reason for patient preference as assessed by a patient preference questionnaire; to evaluate fatigue as assessed by FACIT-Fatigue and quality of life as assessed by EuroQoL EQ-5D; to evaluate dose modifications and time to dose modification; and to evaluate safety.
This is a randomised, double-blind, cross-over study to evaluate the patient preference of pazopanib versus sunitinib in patients with locally advanced or metastatic RCC who have received no prior systemic therapy for advanced or metastatic RCC. Approximately 160 eligible patients will be stratified based on the ECOG performance status (0 vs. 1) and number of metastatic sites of disease (0 and 1 vs. 2+).
The study consists of two 10-weeks treatment periods with a two-week wash-out period between the treatment periods. Patients will receive pazopanib and sunitinib treatment sequentially. At the end of the second treatment period, patient preference and disease assessment are evaluated and the patients are unblinded. Further treatment is at the discretion of the physician. Further treatment with pazopanib is available within the study. Patients requiring other treatments will complete the study at this point.
Patients will be randomized in a 1:1 ratio to receive blinded (overencapsulated) study drug: either 800mg pazopanib orally for 10 weeks followed by 50mg sunitinib orally for 10 weeks or 50mg sunitinib orally for 10 weeks followed by 800mg pazopanib orally for 10 weeks. A two-week washout period will separate the treatment periods (the medical monitor should be consulted if ongoing AEs need to be resolved and the wash-out period needs to be extended). The regimen for sunitinib is 4 weeks of treatment followed by 2 weeks off treatment. To maintain the double-blind during the two weeks off drug for patients on sunitinib ('Treatment Holiday'), patients will be taking matching placebo. No study drug will be taken during the wash-out period in either arm.
Following the two-week wash-out period and disease assessment, all patients are planned to cross over to the second treatment. Patients will be informed of their disease assessment result and any patient that wishes to come off study at this point due to a very significant response, defined as more than a 50% reduction in tumour size (or complete response if non-measurable disease), will have the option to be unblinded to continue with whichever treatment they were on, however each patient case will need to be discussed with the medical monitor prior to unblinding. Patients who were on sunitinib will leave the study and continue treatment outside the study. Patients who were on pazopanib will continue on pazopanib within the pazopanib open-label part of the study. Conversely, should a patient have a very significant response and wish to cross over or complete the study, this must be documented in the patients notes.
Patients crossing over with progressive disease will follow the same visit schedule and assessments and investigators will have the option for these patients to be unblinded or not. The patients' preference will be collected and analysed but will not contribute to the primary, but an exploratory analysis because of the bias caused by progressing on the first treatment. Even if unblinded, patients may continue to receive the second treatment and may receive open label pazopanib after the second treatment within the study if they did not progress on pazopanib.
Patients who withdraw from treatment due to unacceptable toxicity or progression during the first treatment period will cross-over directly to the second treatment following a 2-week wash-out period.
Actual further treatment at the end of the study will be at the discretion of the investigator taking into account both disease assessments results, laboratory results and the patient preference. Choice and rationale for continuing treatment will be documented.
Patients who did not progress on pazopanib and who prefer to continue with pazopanib may continue on pazopanib and will be followed up for safety until the patient comes off pazopanib due to disease progression, toxicity, death or patient choice, which ever is the earliest.
Those patients that may benefit from further treatment with sunitinib for the same reasons as above will receive it off study and will not be followed up, as will patients who receive any other treatment.
Patients are permitted to receive supportive care throughout the study including transfusion of blood and blood products, treatment with antibiotics, anti-emetics, anti-diarrhoeal agents, analgesics, erythropoietin or bisphosphonates, when appropriate. The study treatment will continue until the end of the two treatment periods or unacceptable toxicity or consent withdrawal or death, whichever occurs first.
The patient preference will be ascertained prior to the second disease assessment result being shared with the patient to avoid bias.
6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's enrollment of 169 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Non-childbearing potential (i.e. physiologically incapable of becoming pregnant) Childbearing potential, including any female who has had a negative serum pregnancy test within two weeks prior to the first dose of study treatment, preferably as close to the first dose as possible and agrees to use adequate contraception.
Exclusion Criteria:
Note: Patients who have previously-treated CNS metastases (surgery +/- radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible:
Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour within a visit. The mean SBP/DBP values from each blood pressure assessment must be \<=150/90mmHg in order for a patient to be eligible for the study.
Note: Patients with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible.
800mg pazopanib orally for 10 weeks followed by 50mg sunitinib orally for 10 weeks
Drug: pazopanib · Drug: sunitinib
50mg sunitinib orally for 10 weeks followed by 800mg pazopanib orally for 10 weeks
Drug: pazopanib · Drug: sunitinib
oral anti-angiogenic treatment
Also known as: Votrient
oral anti-angiogenic treatment
Also known as: Sutent
Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ)
The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.
Time frame: End of treatment of both study drugs (maximum of 22 weeks)
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.
Time frame: End of treatment of both study drugs (maximum of 22 weeks)
Change From Period Baseline (BL) in Fatigue as Assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
Change from period (P) BL is computed as participants' (par.) average post-BL fatigue score within each P minus their P-specific BL score. P 1 BL is the P 1 Pre-Dose assessment; P 2 BL is the wash-out assessment. Crossover analyses compared par. average scores on each treatment, adjusting for sequence. FACIT-Fatigue Scale: overall score (0 to 52)=the sum of scores for 13 questions. For each question, par. rated their condition for the past week on a 5-point scale: 0 (not at all) to 4 (very much). A high score indicates low fatigue. A negative change from BL represents a worsening of condition.
Time frame: Day 1 (Period [P] 1 Pre-dose); Weeks 2, 4, 6, 8, and 10 of P 1; during 2-week Wash-out Period (Study Weeks 11 and 12); Weeks 2, 4, 6, and 8 of P 2 (Study Weeks 14, 16, 18, 20, and 22, respectively); End of Study (Week 10 of P 2 [Study Week 22])
Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores
The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: Day 1 (Period 1 Pre-dose); during 2-week Wash-out Period (Study Weeks 11 and 12); and End of Study (Week 10 of Period 2 [Study Week 22])
Time to Dose Modification
For the subset of participants who had a dose modification, time to dose modification was defined as the time from the first dose in each period until the first reduction in dose within a period.
Time frame: End of second treatment period (maximum of 22 weeks)
Number of Participants With the Indicated Number of Dose Reductions
Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.
Time frame: End of second treatment period (maximum of 22 weeks)
Number of Participants With the Indicated Reason for Receiving a Dose Reduction
Dose reduction of study drug was a stepwise reduction of the dose of the study drug: one less capsule was received at each step reduction. Participants were monitored for approximately 10 to 14 days at each dose level. Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.
Time frame: End of second treatment period (maximum of 22 weeks)
Number of Participants With Grade 1 to Grade 5 Adverse Events (AEs)
AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.
Time frame: Baseline to end of study (maximum of 22 weeks)
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE that spans more than one period is considered to be an AE for each period during which the AE increased in grade. There is only one action with respect to study drug recorded for the whole event. As such, it is not always possible to determine in which study period treatment was discontinued due to the AE.
Time frame: Baseline to end of study (maximum of 22 weeks)
Change From Baseline (BL) in Systolic Blood Pressure (SBP) and Diastolic BP (DBP)
When the heart beats, it contracts and pushes blood through the arteries to the rest of body. This force creates pressure on the arteries called SBP. DBP is the pressure in the arteries when the heart rests between beats. Normal levels: SBP (120 mmHg or less); DBP (80 mmHg or less). Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.
Time frame: Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)
Change From Baseline (BL) in Heart Rate
Heart rate (HR) is the number of heartbeats per unit of time, typically expressed as beats per minute. HR can vary as the body's need to absorb oxygen and excrete carbon dioxide changes, such as during exercise or sleep. A normal resting HR ranges from 60 to 100 beats per minute. Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.
Time frame: Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)
There were169 participants randomized and one participant randomized in error with no data available
| Milestone | Sunitinib 50 mg Followed by Pazopanib 800 mg | Pazopanib 800 mg Followed by Sunitinib 50 mg | Open Label Pazopinib |
|---|---|---|---|
| Started | 82 | 86 | 0 |
| Completed | 68 | 68 | 0 |
| Not completed | 14 | 18 | 0 |
| Withdrew: Adverse event | 7 | 10 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 2 | 0 |
| Withdrew: Lack of efficacy | 3 | 5 | 0 |
| Withdrew: Entered open-label period | 1 | 1 | 0 |
| Milestone | Sunitinib 50 mg Followed by Pazopanib 800 mg | Pazopanib 800 mg Followed by Sunitinib 50 mg | Open Label Pazopinib |
|---|---|---|---|
| Started | 68 | 68 | 0 |
| Completed | 64 | 62 | 0 |
| Not completed | 4 | 6 | 0 |
| Withdrew: Adverse event | 2 | 1 | 0 |
| Withdrew: Physician decision | 0 | 1 | 0 |
| Withdrew: Entered open-label period | 1 | 0 | 0 |
| Withdrew: Lack of efficacy | 1 | 4 | 0 |
| Milestone | Sunitinib 50 mg Followed by Pazopanib 800 mg | Pazopanib 800 mg Followed by Sunitinib 50 mg | Open Label Pazopinib |
|---|---|---|---|
| Started | 0 | 0 | 84 |
| Completed | 0 | 0 | 0 |
| Not completed | 0 | 0 | 84 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 0 | 12 |
| Withdrew: Lack of efficacy | 0 | 0 | 51 |
| Withdrew: Physician decision | 0 | 0 | 20 |
The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.
| participants | Sunitinib 50 mg Followed by Pazopanib 800 mg | Pazopanib 800 mg Followed by Sunitinib 50 mg |
|---|---|---|
| Sunitinib | 19 | 6 |
| Pazopanib | 37 | 43 |
| No preference | 4 | 5 |
The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.
| participants | Sunitinib | Pazopanib |
|---|---|---|
| Fatigue had less impact on life, Yes | 12 | 47 |
| Fatigue had less impact on life, No | 8 | 26 |
| Fatigue had less impact on life, not applicable (N | 5 | 6 |
| Soreness in hands/feet had less impact, Yes | 6 | 30 |
| Soreness in hands/feet had less impact, No | 7 | 22 |
| Soreness in hands/feet had less impact, NA | 12 | 28 |
| Soreness in mouth/throat had less impact, Yes | 6 | 32 |
| Soreness in mouth/throat had less impact, No | 8 | 25 |
| Soreness in mouth/throat had less impact, NA | 11 | 23 |
| Loss of appetite had less impact, Yes | 10 | 28 |
| Loss of appetite had less impact, No | 8 | 28 |
| Loss of appetite had less impact, NA | 7 | 22 |
| Change in hair color had less impact, Yes | 5 | 9 |
| Change in hair color had less impact, No | 11 | 51 |
| Change in hair color had less impact, NA | 9 | 20 |
| Nausea/vomiting had less impact, Yes | 11 | 32 |
| Nausea/vomiting had less impact, No | 7 | 30 |
| Nausea/vomiting had less impact, NA | 7 | 17 |
| Diarrhea had less impact, Yes | 16 | 21 |
| Diarrhea had less impact, No | 5 | 44 |
| Diarrhea had less impact, NA | 4 | 15 |
| Pain in stomach area had less impact, Yes | 9 | 23 |
| Pain in stomach area had less impact, No | 4 | 30 |
| Pain in stomach area had less impact, NA | 12 | 27 |
| Changes in food tastes had less impact, Yes | 5 | 44 |
| Changes in food tastes had less impact, No | 14 | 23 |
| Changes in food tastes had less impact, NA | 6 | 12 |
| Quality of life better, Yes | 15 | 65 |
| Quality of life better, No | 6 | 12 |
| Quality of life better, NA | 4 | 2 |
| Other, Yes | 5 | 14 |
| Other, No | 0 | 0 |
| Other, NA | 20 | 66 |
Change from period (P) BL is computed as participants' (par.) average post-BL fatigue score within each P minus their P-specific BL score. P 1 BL is the P 1 Pre-Dose assessment; P 2 BL is the wash-out assessment. Crossover analyses compared par. average scores on each treatment, adjusting for sequence. FACIT-Fatigue Scale: overall score (0 to 52)=the sum of scores for 13 questions. For each question, par. rated their condition for the past week on a 5-point scale: 0 (not at all) to 4 (very much). A high score indicates low fatigue. A negative change from BL represents a worsening of condition.
| Scores on a scale | Sunitinib 50 mg Followed by Pazopanib 800 mg | Pazopanib 800 mg Followed by Sunitinib 50 mg |
|---|---|---|
| Period 1 Average; n=77, 79 | -4.4 ± 7.73 | -4.6 ± 9.22 |
| Period 2 Average; n=63, 65 | -3.6 ± 7.11 | -7.3 ± 11.16 |
The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
| Scores on a scale | Sunitinib 50 mg Followed by Pazopanib 800 mg | Pazopanib 800 mg Followed by Sunitinib 50 mg |
|---|---|---|
| Thermometer Score, Day 1; n=74, 79 | 75.7 ± 17.65 | 74.8 ± 18.54 |
| Thermometer Score, Washout; n=60, 63 | 74.4 ± 16.76 | 69.8 ± 19.94 |
| Thermometer Score, End of Study; n=51, 45 | 71.3 ± 16.19 | 65.1 ± 22.55 |
| Utility Score, Day 1; n=76, 81 | 0.7625 ± 0.25331 | 0.7664 ± 0.22946 |
| Utility Score, Washout; n=61, 67 | 0.8103 ± 0.20776 | 0.7595 ± 0.26826 |
| Utility Score, End of Study; n=52, 47 | 0.7487 ± 0.21324 | 0.6325 ± 0.29635 |
For the subset of participants who had a dose modification, time to dose modification was defined as the time from the first dose in each period until the first reduction in dose within a period.
| weeks | Sunitinib | Pazopanib |
|---|---|---|
| Time to Dose Modification | 3.7 (2.7 to 5.9) | 4.0 (2.1 to 6.0) |
Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.
| participants | Sunitinib | Pazopanib |
|---|---|---|
| 1 | 16 | 8 |
| 2 | 10 | 11 |
| 3 or more | 4 | 1 |
Dose reduction of study drug was a stepwise reduction of the dose of the study drug: one less capsule was received at each step reduction. Participants were monitored for approximately 10 to 14 days at each dose level. Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.
| participants | Sunitinib | Pazopanib |
|---|---|---|
| Adverse Event | 46 | 33 |
| Other | 3 | 0 |
AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.
| participants | Sunitinib | Pazopanib |
|---|---|---|
| Grade 0 | 0 | 0 |
| Grade 1 | 20 | 25 |
| Grade 2 | 57 | 63 |
| Grade 3 | 58 | 51 |
| Grade 4 | 11 | 8 |
| Grade 5 | 1 | 0 |
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE that spans more than one period is considered to be an AE for each period during which the AE increased in grade. There is only one action with respect to study drug recorded for the whole event. As such, it is not always possible to determine in which study period treatment was discontinued due to the AE.
| participants | Sunitinib | Pazopanib |
|---|---|---|
| Fatigue | 5 | 3 |
| Alanine aminotransferase increased | 2 | 4 |
| Vomiting | 1 | 3 |
| Aspartate aminotransferase increased | 0 | 3 |
| Diarrhoea | 1 | 2 |
| Thrombocytopenia | 3 | 0 |
| Acute myocardial infarction | 1 | 1 |
| Asthenia | 2 | 0 |
| Back pain | 1 | 1 |
| Dyspnoea | 2 | 0 |
| Epistaxis | 2 | 0 |
| Hypertension | 2 | 0 |
| Nasal congestion | 1 | 1 |
| Pleural effusion | 2 | 0 |
| Transient ischaemic attack | 0 | 2 |
| Atrial flutter | 0 | 1 |
| Blood potassium decreased | 1 | 0 |
| Cardiac disorder | 0 | 1 |
| Cardiac failure | 0 | 1 |
| Cough | 1 | 0 |
| Decreased appetite | 1 | 0 |
| Dizziness | 0 | 1 |
| Dysgeusia | 0 | 1 |
| Haematemesis | 0 | 1 |
| Haematoma | 1 | 0 |
| Haematuria | 1 | 0 |
| Haemorrhage intracranial | 1 | 0 |
| Headache | 1 | 0 |
| Hepatic function abnormal | 0 | 1 |
| Hepatotoxicity | 0 | 1 |
| Infection | 1 | 0 |
| Infectious peritonitis | 0 | 1 |
| Influenza | 1 | 0 |
| Influenza like illness | 1 | 0 |
| Mucosal inflammation | 1 | 0 |
| Myocardial ischaemia | 0 | 1 |
| Nausea | 0 | 1 |
| Neutropenic infection | 1 | 0 |
| Ovarian cyst | 1 | 0 |
| Pain in extremity | 1 | 0 |
| Palmar-plantar erythrodysaesthesia syndrome | 1 | 0 |
| Pancytopenia | 1 | 0 |
| Proteinuria | 0 | 1 |
| Pyrexia | 1 | 0 |
| Rash | 0 | 1 |
| Renal failure | 1 | 0 |
| Respiratory failure | 0 | 1 |
| Sinusitis | 1 | 0 |
| Skin ulcer | 0 | 1 |
| Spinal cord compression | 0 | 1 |
| Stomatitis | 1 | 0 |
| Tooth infection | 1 | 0 |
| Transaminases increased | 1 | 0 |
| Urine protein/creatinine ratio decreased | 1 | 0 |
| Weight decreased | 1 | 0 |
When the heart beats, it contracts and pushes blood through the arteries to the rest of body. This force creates pressure on the arteries called SBP. DBP is the pressure in the arteries when the heart rests between beats. Normal levels: SBP (120 mmHg or less); DBP (80 mmHg or less). Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.
| Millimeters of mercury (mmHg) | Sunitinib | Pazopanib |
|---|---|---|
| SBP, Week 2; n=139, 147 | 6.3 ± 15.26 | 7.5 ± 16.36 |
| SBP, Week 6; n=109, 134 | -0.4 ± 18.65 | 7.5 ± 17.21 |
| SBP, Week 10; n=61, 64 | 4.5 ± 18.43 | 4.7 ± 20.45 |
| DBP, Week 2; n=139, 147 | 6.5 ± 9.91 | 6.5 ± 10.49 |
| DBP, Week 6; n=109, 134 | -0.4 ± 9.48 | 6.9 ± 10.87 |
| DBP, Week 10; n=61, 64 | 3.1 ± 10.69 | 5.6 ± 11.44 |
Heart rate (HR) is the number of heartbeats per unit of time, typically expressed as beats per minute. HR can vary as the body's need to absorb oxygen and excrete carbon dioxide changes, such as during exercise or sleep. A normal resting HR ranges from 60 to 100 beats per minute. Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.
| Beats per minute | Sunitinib | Pazopanib |
|---|---|---|
| Week 2, n=137, 145 | -3.1 ± 12.39 | -2.7 ± 13.09 |
| Week 6, n=106, 131 | 0.8 ± 11.43 | -3.3 ± 12.41 |
| Week 10, n=60, 64 | -3.8 ± 13.54 | -1.8 ± 13.84 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sunitinib | — | 35/148 (23.6%) | 143/148 (96.6%) |
| Pazopanib | — | 30/153 (19.6%) | 142/153 (92.8%) |
| Open Label Pazopanib | — | 15/84 (17.9%) | 73/84 (86.9%) |
| Event | Sunitinib | Pazopanib | Open Label Pazopanib |
|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 3/148 | 2/153 | 2/84 |
| ThrombocytopeniaBlood and lymphatic system disorders | 3/148 | 0/153 | 0/84 |
| FatigueGeneral disorders | 3/148 | 2/153 | 1/84 |
| General physical health deteriorationGeneral disorders | 3/148 | 0/153 | 0/84 |
| Alanine aminotransferase increasedInvestigations | 2/148 | 3/153 | 1/84 |
| HypertensionVascular disorders | 2/148 | 3/153 | 0/84 |
| Rectal haemorrhageGastrointestinal disorders | 2/148 | 0/153 | 0/84 |
| InfectionInfections and infestations | 2/148 | 0/153 | 0/84 |
| HaematuriaRenal and urinary disorders | 2/148 | 1/153 | 0/84 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 2/148 | 0/153 | 0/84 |
| Event | Sunitinib | Pazopanib | Open Label Pazopanib |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 49/148 | 63/153 | 45/84 |
| NauseaGastrointestinal disorders | 46/148 | 50/153 | 26/84 |
| FatigueGeneral disorders | 42/148 | 43/153 | 25/84 |
| DysgeusiaNervous system disorders | 40/148 | 25/153 | 12/84 |
| Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders | 39/148 | 27/153 | 11/84 |
| HypertensionVascular disorders | 37/148 | 32/153 | 13/84 |
| AstheniaGeneral disorders | 35/148 | 26/153 | 16/84 |
| Mucosal inflammationGeneral disorders | 32/148 | 25/153 | 6/84 |
| VomitingGastrointestinal disorders | 26/148 | 21/153 | 18/84 |
| Decreased appetiteMetabolism and nutrition disorders | 30/148 | 32/153 | 18/84 |
| Age, Continuous(Years) | Sunitinib 50 mg Followed by Pazopanib 800 mg | Pazopanib 800 mg Followed by Sunitinib 50 mg | Total |
|---|---|---|---|
| Mean | 62.1 ± 9.56 | 62.2 ± 11.35 | 62.2 ± 10.48 |
| Sex: Female, Male(Participants) | Sunitinib 50 mg Followed by Pazopanib 800 mg | Pazopanib 800 mg Followed by Sunitinib 50 mg | Total |
|---|---|---|---|
| Female | 30 | 25 | 55 |
| Male | 52 | 61 | 113 |
| Race/Ethnicity, Customized(participants) | Sunitinib 50 mg Followed by Pazopanib 800 mg | Pazopanib 800 mg Followed by Sunitinib 50 mg | Total |
|---|---|---|---|
| African American/African Heritage | 1 | 0 | 1 |
| Asian-Central/South Asian Heritage | 1 | 0 | 1 |
| White | 74 | 83 | 157 |
| Missing | 6 | 3 | 9 |
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Novartis Pharmaceuticals