The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01223027
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : November 6, 2015
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Renal Cell Carcinoma
Interventions Drug: Dovitinib
Drug: Sorafenib
Enrollment 564
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dovitinib + Best Supportive Care (BSC) Sorafenib + BSC
Hide Arm/Group Description Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule. Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
Period Title: Overall Study
Started 284 286
Completed 10 [1] 9 [1]
Not Completed 274 277
Reason Not Completed
Adverse Event             20             10
Death             42             42
Lost to Follow-up             2             1
Physician Decision             4             8
Progressive Disease             167             183
Protocol Violation             2             1
Subject/guardian decicion             18             16
New therapy for study indication             17             8
Study terminated by sponsor             2             8
[1]
Completed = Ongoing at data cut-off of 25-Jan-2013
Arm/Group Title Dovitinib + Best Supportive Care (BSC) Sorafenib + BSC Total
Hide Arm/Group Description Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule. Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily. Total of all reporting groups
Overall Number of Baseline Participants 284 286 570
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) consisted of all randomized patients.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 284 participants 286 participants 570 participants
< 65 years 187 165 352
>= 65 years 97 121 218
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants 286 participants 570 participants
Female
71
  25.0%
67
  23.4%
138
  24.2%
Male
213
  75.0%
219
  76.6%
432
  75.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 284 participants 286 participants 570 participants
Caucasian 233 232 465
Asian 42 40 82
Black 3 5 8
Unknown 1 6 7
Other 5 3 8
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 284 participants 286 participants 570 participants
74.9  (15.39) 75.5  (15.96) 75.2  (15.67)
Karnofsky performance score  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 284 participants 286 participants 570 participants
100 -Normal no complaints; no evidence of disease 83 73 156
90 - Able to carry on normal activity 93 101 194
80 - Normal activity with efforts 73 83 156
70 - Cares for self 35 29 64
Memorial Sloan Kettering Cancer Center Risk Criteria (MSKCC) risk group   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 284 participants 286 participants 570 participants
Favorable 70 65 135
Intermediate 156 155 311
Poor 54 61 115
Missing 4 5 9
[1]
Measure Description:

Pts were place into 3 distinct risk groups based on the number of risk factors that the patient had at baseline:

Low Karnofsky Performance Status: <80%, Low serum hemoglobin: males (≤ 13 g/dL); females (≤ 11.5 g/dL), High corrected serum calcium: ≥ 10 mg/dL. Pts in the favorable group are expected to live longer while patients in the poor risk group are expected to die sooner than the patients in the other groups.

Favorable = Pt. had none of the risks; Intermediate = Patient had 1 risk factor; Poor = Pt. had 2 or 3 risk factors Missing = not enough information at baseline to categorize
1.Primary Outcome
Title Progression Free Survival (PFS) Per Independent Central Radiology Review
Hide Description Assessed according to RECIST 1.1. PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. If a patient had not progressed or died, on the date of the analysis cut-off or when he/she received any further anti-neoplastic therapy, PFS was censored on the date of last tumor assessment before the cutoff date or the anti-neoplastic therapy date. The distribution of PFS was estimated using the Kaplan-Meier method. The median PFS along with 95% confidence intervals was presented by treatment group.
Time Frame Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all randomized patients.
Arm/Group Title Dovitinib + Best Supportive Care (BSC) Sorafenib + BSC
Hide Arm/Group Description:
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
Overall Number of Participants Analyzed 284 286
Median (95% Confidence Interval)
Unit of Measure: Months
3.7
(3.5 to 3.9)
3.6
(3.5 to 3.7)
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (OS) was the key secondary endpoint and was defined as the time from date of randomization to the date of death due to any cause. If a patient was not known to have died, survival was censored on the date of last contact.
Time Frame until at least 386 deaths are documented in the clinical database.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all randomized patients.
Arm/Group Title Dovitinib + Best Supportive Care (BSC) Sorafenib + BSC
Hide Arm/Group Description:
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
Overall Number of Participants Analyzed 284 286
Median (95% Confidence Interval)
Unit of Measure: Months
11.1
(9.5 to 13.4)
11.0
(8.6 to 13.5)
3.Secondary Outcome
Title Progression Free Survival (PFS) Per Investigator's Radiology Review
Hide Description PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. The primary analysis for PFS (based on central review) was also to be repeated on FAS considering the Investigator assessments and using the same analytical conventions as the primary analysis.
Time Frame Until disease progression or discontinuation of treatment due to unacceptable toxicity
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all randomized patients.
Arm/Group Title Dovitinib + Best Supportive Care (BSC) Sorafenib + BSC
Hide Arm/Group Description:
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
Overall Number of Participants Analyzed 284 286
Median (95% Confidence Interval)
Unit of Measure: Months
3.9
(3.7 to 5.1)
3.9
(3.7 to 5.0)
4.Secondary Outcome
Title Percentage of Participants With Overall Response Rate (ORR) by Central Radiology Review
Hide Description Overall response rate (ORR) was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR). Best overall esponse (BOR) for each patient was determined from the sequence of overall (lesion) responses according to the following rules: CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. SD = at least one SD assessment (or better) > 6 weeks after randomization (and not qualifying for CR or PR). PD = progression ≤ 17 weeks after randomization (and not qualifying for CR, PR or SD).
Time Frame Until disease progression or discontinuation of treatment due to unacceptable toxicity
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all randomized patients.
Arm/Group Title Dovitinib + Best Supportive Care (BSC) Sorafenib + BSC
Hide Arm/Group Description:
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
Overall Number of Participants Analyzed 284 286
Measure Type: Number
Unit of Measure: Percentage of Participants
3.9 3.8
5.Secondary Outcome
Title Time to Definitive Worsening of Karnofsky Performance Status (KPS)
Hide Description Time to definitive worsening of Karnofsky performance status (KPS) was defined as the time from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier. Definitive worsening was defined as a definitive decrease in performance status by at least one Karnofsky category (i.e. at least 10 points less) compared to Baseline. Worsening was considered definitive if no later increase above the defined threshold was observed within the course of the study. A single measure reporting a decrease in Karnofsky performance status was sufficient to consider it as definitive only if it was the last one available for this patient. Time to definitive worsening of KPS was analyzed at the time of the final analysis for PFS.
Time Frame from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consited of all randomized patients.
Arm/Group Title Dovitinib + Best Supportive Care (BSC) Sorafenib + BSC
Hide Arm/Group Description:
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
Overall Number of Participants Analyzed 284 286
Median (95% Confidence Interval)
Unit of Measure: Months
5.1
(3.8 to 6.5)
5.7
(4.6 to 7.4)
6.Secondary Outcome
Title Patient-reported Outcomes (PROs): Time to Deterioration of Functional Assessment of Cancer Therapy-Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) by at Least 2 Scores
Hide Description The Kidney Cancer Symptom Index - Disease Related Symptoms (FKSI-DRS) is a validated symptom scale used in studies of patients with kidney cancer. It includes 9-items that assess pain, bone pain, fatigue, lack of energy, shortness of breath, fevers, weight loss, coughing, and blood in urine and responses to each question are answered on a 5-point Likert-type scale ranging from 0 to 4 (e.g., 0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). FKSI-DRS scores range from 0 to 36, where higher scores correspond to better outcomes (eg, fewer symptoms).
Time Frame from date of randomization, at least 2 score units
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all randomized patients.
Arm/Group Title Dovitinib + Best Supportive Care (BSC) Sorafenib + BSC
Hide Arm/Group Description:
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
Overall Number of Participants Analyzed 284 286
Median (95% Confidence Interval)
Unit of Measure: Months
4.9
(4.5 to 6.6)
6.4
(5.5 to 7.7)
7.Secondary Outcome
Title Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Physical Functioning (PF) Scale of EORTC QLQ-C30 by at Least 10%
Hide Description The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Each of the multiitem scales includes a different set of items - no item occurs in more than one scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome.
Time Frame from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all randomized patients.
Arm/Group Title Dovitinib + Best Supportive Care (BSC) Sorafenib + BSC
Hide Arm/Group Description:
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
Overall Number of Participants Analyzed 284 286
Median (95% Confidence Interval)
Unit of Measure: Months
3.8
(3.2 to 4.6)
5.6
(4.5 to 6.4)
8.Secondary Outcome
Title Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Quality of Life (QoL) Scale Scores of EORTC QLQ-C30 by at Least 10%
Hide Description The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Each of the multiitem scales includes a different set of items - no item occurs in more than one scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome.
Time Frame from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all randomized patients.
Arm/Group Title Dovitinib + Best Supportive Care (BSC) Sorafenib + BSC
Hide Arm/Group Description:
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
Overall Number of Participants Analyzed 284 286
Median (95% Confidence Interval)
Unit of Measure: Months
3.7
(2.8 to 4.6)
4.5
(3.7 to 5.5)
9.Secondary Outcome
Title Pre-dose Concentration in Plasma in Dovitinib
Hide Description Predose concentrations of dovitinib were summarized by visit using PAS. All concentration data was listed by patient and time point using FAS. Mean pre-dose concentrations along with standard deviation (SD) was plotted over time if appropriate.
Time Frame Week 2 Day 5, Week 4 Day 5, Week 6 Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set (PAS) consisted of all patients who received at least one dose of dovitinib and had at least one evaluable post-Baseline dovitinib concentration measurement.
Arm/Group Title Dovitinib + Best Supportive Care (BSC)
Hide Arm/Group Description:
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
Overall Number of Participants Analyzed 284
Mean (Standard Deviation)
Unit of Measure: ng/ml
Week 2 Day 5 (n: 205) 128.06  (92.571)
Week 4 Day 5 (n: 202) 114.08  (77.884)
Week 6 Day 5 (n: 170) 118.27  (84.246)
Time Frame [Not Specified]
Adverse Event Reporting Description 570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
 
Arm/Group Title Dovitinib Sorafenib
Hide Arm/Group Description Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule. Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
All-Cause Mortality
Dovitinib Sorafenib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Dovitinib Sorafenib
Affected / at Risk (%) Affected / at Risk (%)
Total   133/280 (47.50%)   112/284 (39.44%) 
Blood and lymphatic system disorders     
ANAEMIA † 1  7/280 (2.50%)  7/284 (2.46%) 
LEUKOPENIA † 1  2/280 (0.71%)  0/284 (0.00%) 
LYMPHOPENIA † 1  1/280 (0.36%)  0/284 (0.00%) 
NEUTROPENIA † 1  1/280 (0.36%)  0/284 (0.00%) 
THROMBOCYTOPENIA † 1  2/280 (0.71%)  1/284 (0.35%) 
Cardiac disorders     
ACUTE MYOCARDIAL INFARCTION † 1  1/280 (0.36%)  0/284 (0.00%) 
ATRIAL FIBRILLATION † 1  0/280 (0.00%)  1/284 (0.35%) 
CARDIAC FAILURE † 1  0/280 (0.00%)  1/284 (0.35%) 
CARDIAC FAILURE CONGESTIVE † 1  1/280 (0.36%)  0/284 (0.00%) 
CARDIAC TAMPONADE † 1  1/280 (0.36%)  0/284 (0.00%) 
CARDIOPULMONARY FAILURE † 1  0/280 (0.00%)  1/284 (0.35%) 
CORONARY ARTERY OCCLUSION † 1  1/280 (0.36%)  0/284 (0.00%) 
LEFT VENTRICULAR DYSFUNCTION † 1  1/280 (0.36%)  0/284 (0.00%) 
MYOCARDIAL INFARCTION † 1  3/280 (1.07%)  0/284 (0.00%) 
MYOCARDIAL ISCHAEMIA † 1  0/280 (0.00%)  1/284 (0.35%) 
SUPRAVENTRICULAR TACHYCARDIA † 1  0/280 (0.00%)  2/284 (0.70%) 
TACHYCARDIA † 1  1/280 (0.36%)  0/284 (0.00%) 
ACUTE CORONARY SYNDROME † 1  1/280 (0.36%)  1/284 (0.35%) 
CARDIO-RESPIRATORY ARREST † 1  0/280 (0.00%)  1/284 (0.35%) 
Endocrine disorders     
HYPERCALCAEMIA OF MALIGNANCY † 1  0/280 (0.00%)  1/284 (0.35%) 
Eye disorders     
DIPLOPIA † 1  1/280 (0.36%)  0/284 (0.00%) 
CONJUNCTIVITIS † 1  1/280 (0.36%)  0/284 (0.00%) 
Gastrointestinal disorders     
ABDOMINAL HERNIA † 1  0/280 (0.00%)  1/284 (0.35%) 
ABDOMINAL PAIN † 1  7/280 (2.50%)  1/284 (0.35%) 
ABDOMINAL PAIN UPPER † 1  2/280 (0.71%)  2/284 (0.70%) 
ABDOMINAL TENDERNESS † 1  0/280 (0.00%)  1/284 (0.35%) 
ANAL FISSURE † 1  0/280 (0.00%)  1/284 (0.35%) 
ASCITES † 1  0/280 (0.00%)  2/284 (0.70%) 
COLONIC FISTULA † 1  1/280 (0.36%)  0/284 (0.00%) 
CONSTIPATION † 1  1/280 (0.36%)  2/284 (0.70%) 
DIARRHOEA † 1  10/280 (3.57%)  4/284 (1.41%) 
DYSPEPSIA † 1  1/280 (0.36%)  0/284 (0.00%) 
DYSPHAGIA † 1  3/280 (1.07%)  0/284 (0.00%) 
FAECAL INCONTINENCE † 1  1/280 (0.36%)  0/284 (0.00%) 
GASTRIC PERFORATION † 1  0/280 (0.00%)  1/284 (0.35%) 
GASTROINTESTINAL HAEMORRHAGE † 1  1/280 (0.36%)  1/284 (0.35%) 
GASTROINTESTINAL MOTILITY DISORDER † 1  0/280 (0.00%)  1/284 (0.35%) 
ILEUS † 1  2/280 (0.71%)  2/284 (0.70%) 
ILEUS PARALYTIC † 1  0/280 (0.00%)  1/284 (0.35%) 
INTESTINAL OBSTRUCTION † 1  3/280 (1.07%)  0/284 (0.00%) 
LARGE INTESTINAL HAEMORRHAGE † 1  1/280 (0.36%)  0/284 (0.00%) 
LARGE INTESTINE PERFORATION † 1  1/280 (0.36%)  0/284 (0.00%) 
LOWER GASTROINTESTINAL HAEMORRHAGE † 1  1/280 (0.36%)  0/284 (0.00%) 
NAUSEA † 1  6/280 (2.14%)  3/284 (1.06%) 
OBSTRUCTION GASTRIC † 1  0/280 (0.00%)  3/284 (1.06%) 
ODYNOPHAGIA † 1  0/280 (0.00%)  1/284 (0.35%) 
ORAL PAIN † 1  1/280 (0.36%)  0/284 (0.00%) 
PANCREATITIS † 1  2/280 (0.71%)  0/284 (0.00%) 
PNEUMOPERITONEUM † 1  0/280 (0.00%)  1/284 (0.35%) 
RECTAL HAEMORRHAGE † 1  0/280 (0.00%)  1/284 (0.35%) 
RETROPERITONEAL HAEMATOMA † 1  0/280 (0.00%)  1/284 (0.35%) 
RETROPERITONEAL HAEMORRHAGE † 1  1/280 (0.36%)  0/284 (0.00%) 
STOMATITIS † 1  1/280 (0.36%)  3/284 (1.06%) 
VOMITING † 1  8/280 (2.86%)  3/284 (1.06%) 
General disorders     
ASTHENIA † 1  3/280 (1.07%)  6/284 (2.11%) 
DEATH † 1  1/280 (0.36%)  0/284 (0.00%) 
FATIGUE † 1  4/280 (1.43%)  5/284 (1.76%) 
GENERAL PHYSICAL HEALTH DETERIORATION † 1  7/280 (2.50%)  14/284 (4.93%) 
MALAISE † 1  2/280 (0.71%)  0/284 (0.00%) 
MULTI-ORGAN FAILURE † 1  1/280 (0.36%)  2/284 (0.70%) 
NON-CARDIAC CHEST PAIN † 1  1/280 (0.36%)  1/284 (0.35%) 
OEDEMA PERIPHERAL † 1  1/280 (0.36%)  0/284 (0.00%) 
PAIN † 1  3/280 (1.07%)  3/284 (1.06%) 
PERFORMANCE STATUS DECREASED † 1  1/280 (0.36%)  3/284 (1.06%) 
PYREXIA † 1  7/280 (2.50%)  5/284 (1.76%) 
SUDDEN DEATH † 1  0/280 (0.00%)  1/284 (0.35%) 
GENERALISED OEDEMA † 1  2/280 (0.71%)  0/284 (0.00%) 
Hepatobiliary disorders     
CHOLECYSTITIS † 1  0/280 (0.00%)  1/284 (0.35%) 
HEPATIC FAILURE † 1  1/280 (0.36%)  1/284 (0.35%) 
JAUNDICE CHOLESTATIC † 1  1/280 (0.36%)  0/284 (0.00%) 
Immune system disorders     
SERUM SICKNESS † 1  1/280 (0.36%)  0/284 (0.00%) 
Infections and infestations     
ANAL ABSCESS † 1  0/280 (0.00%)  1/284 (0.35%) 
CYSTITIS † 1  1/280 (0.36%)  0/284 (0.00%) 
EMPHYSEMATOUS CYSTITIS † 1  1/280 (0.36%)  0/284 (0.00%) 
GASTROENTERITIS † 1  0/280 (0.00%)  1/284 (0.35%) 
INFECTIVE GLOSSITIS † 1  1/280 (0.36%)  0/284 (0.00%) 
PNEUMONIA † 1  7/280 (2.50%)  8/284 (2.82%) 
ERYSIPELAS † 1  1/280 (0.36%)  0/284 (0.00%) 
LOBAR PNEUMONIA † 1  1/280 (0.36%)  0/284 (0.00%) 
LUNG INFECTION † 1  1/280 (0.36%)  1/284 (0.35%) 
MENINGITIS CRYPTOCOCCAL † 1  1/280 (0.36%)  0/284 (0.00%) 
PYELONEPHRITIS ACUTE † 1  1/280 (0.36%)  0/284 (0.00%) 
RESPIRATORY TRACT INFECTION † 1  1/280 (0.36%)  0/284 (0.00%) 
SEPSIS † 1  7/280 (2.50%)  0/284 (0.00%) 
URINARY TRACT INFECTION † 1  1/280 (0.36%)  2/284 (0.70%) 
Injury, poisoning and procedural complications     
CONTRAST MEDIA REACTION † 1  1/280 (0.36%)  0/284 (0.00%) 
FEMORAL NECK FRACTURE † 1  1/280 (0.36%)  0/284 (0.00%) 
FEMUR FRACTURE † 1  1/280 (0.36%)  1/284 (0.35%) 
HUMERUS FRACTURE † 1  1/280 (0.36%)  0/284 (0.00%) 
OVERDOSE † 1  1/280 (0.36%)  0/284 (0.00%) 
SUBDURAL HAEMATOMA † 1  1/280 (0.36%)  0/284 (0.00%) 
TOXICITY TO VARIOUS AGENTS † 1  1/280 (0.36%)  0/284 (0.00%) 
UPPER LIMB FRACTURE † 1  1/280 (0.36%)  0/284 (0.00%) 
WRIST FRACTURE † 1  1/280 (0.36%)  0/284 (0.00%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED † 1  0/280 (0.00%)  1/284 (0.35%) 
AMYLASE INCREASED † 1  1/280 (0.36%)  0/284 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED † 1  0/280 (0.00%)  1/284 (0.35%) 
BLOOD ALKALINE PHOSPHATASE INCREASED † 1  1/280 (0.36%)  0/284 (0.00%) 
BLOOD CREATININE INCREASED † 1  0/280 (0.00%)  1/284 (0.35%) 
HAEMATOCRIT DECREASED † 1  0/280 (0.00%)  1/284 (0.35%) 
LIPASE INCREASED † 1  1/280 (0.36%)  0/284 (0.00%) 
LIVER FUNCTION TEST ABNORMAL † 1  0/280 (0.00%)  1/284 (0.35%) 
PLATELET COUNT DECREASED † 1  2/280 (0.71%)  0/284 (0.00%) 
TROPONIN INCREASED † 1  1/280 (0.36%)  0/284 (0.00%) 
WEIGHT DECREASED † 1  2/280 (0.71%)  0/284 (0.00%) 
Metabolism and nutrition disorders     
HYPONATRAEMIA † 1  3/280 (1.07%)  4/284 (1.41%) 
HYPOPROTEINAEMIA † 1  1/280 (0.36%)  0/284 (0.00%) 
LACTIC ACIDOSIS † 1  0/280 (0.00%)  1/284 (0.35%) 
TUMOUR LYSIS SYNDROME † 1  0/280 (0.00%)  1/284 (0.35%) 
CACHEXIA † 1  2/280 (0.71%)  0/284 (0.00%) 
DECREASED APPETITE † 1  2/280 (0.71%)  4/284 (1.41%) 
DEHYDRATION † 1  6/280 (2.14%)  5/284 (1.76%) 
HYPERCALCAEMIA † 1  3/280 (1.07%)  2/284 (0.70%) 
HYPERKALAEMIA † 1  2/280 (0.71%)  2/284 (0.70%) 
HYPERTRIGLYCERIDAEMIA † 1  1/280 (0.36%)  0/284 (0.00%) 
HYPOCALCAEMIA † 1  1/280 (0.36%)  0/284 (0.00%) 
HYPOGLYCAEMIA † 1  0/280 (0.00%)  1/284 (0.35%) 
HYPOKALAEMIA † 1  2/280 (0.71%)  0/284 (0.00%) 
HYPOMAGNESAEMIA † 1  1/280 (0.36%)  0/284 (0.00%) 
HYPOPHAGIA † 1  2/280 (0.71%)  0/284 (0.00%) 
Musculoskeletal and connective tissue disorders     
AMYOTROPHY † 1  1/280 (0.36%)  0/284 (0.00%) 
ARTHRALGIA † 1  2/280 (0.71%)  3/284 (1.06%) 
BACK PAIN † 1  5/280 (1.79%)  7/284 (2.46%) 
BONE PAIN † 1  2/280 (0.71%)  2/284 (0.70%) 
FLANK PAIN † 1  1/280 (0.36%)  0/284 (0.00%) 
INTERVERTEBRAL DISC DISORDER † 1  1/280 (0.36%)  0/284 (0.00%) 
MUSCULAR WEAKNESS † 1  0/280 (0.00%)  1/284 (0.35%) 
MUSCULOSKELETAL CHEST PAIN † 1  1/280 (0.36%)  0/284 (0.00%) 
MUSCULOSKELETAL PAIN † 1  0/280 (0.00%)  1/284 (0.35%) 
MYALGIA † 1  1/280 (0.36%)  0/284 (0.00%) 
MYOPATHY † 1  1/280 (0.36%)  0/284 (0.00%) 
NECK PAIN † 1  0/280 (0.00%)  1/284 (0.35%) 
OSTEONECROSIS OF JAW † 1  1/280 (0.36%)  0/284 (0.00%) 
PAIN IN EXTREMITY † 1  1/280 (0.36%)  1/284 (0.35%) 
PATHOLOGICAL FRACTURE † 1  0/280 (0.00%)  2/284 (0.70%) 
SPINAL COLUMN STENOSIS † 1  0/280 (0.00%)  1/284 (0.35%) 
SPINAL OSTEOARTHRITIS † 1  1/280 (0.36%)  0/284 (0.00%) 
INTERVERTEBRAL DISC COMPRESSION † 1  1/280 (0.36%)  0/284 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
CANCER PAIN † 1  0/280 (0.00%)  1/284 (0.35%) 
INFECTED NEOPLASM † 1  1/280 (0.36%)  0/284 (0.00%) 
MALIGNANT PLEURAL EFFUSION † 1  0/280 (0.00%)  1/284 (0.35%) 
METASTASES TO CENTRAL NERVOUS SYSTEM † 1  1/280 (0.36%)  1/284 (0.35%) 
METASTATIC PAIN † 1  1/280 (0.36%)  1/284 (0.35%) 
OESOPHAGEAL CARCINOMA † 1  0/280 (0.00%)  1/284 (0.35%) 
PERICARDIAL EFFUSION MALIGNANT † 1  1/280 (0.36%)  1/284 (0.35%) 
TUMOUR PAIN † 1  3/280 (1.07%)  0/284 (0.00%) 
RENAL CELL CARCINOMA † 1  1/280 (0.36%)  0/284 (0.00%) 
Nervous system disorders     
APHASIA † 1  1/280 (0.36%)  0/284 (0.00%) 
CEREBROVASCULAR ACCIDENT † 1  0/280 (0.00%)  1/284 (0.35%) 
CONVULSION † 1  2/280 (0.71%)  0/284 (0.00%) 
DEPRESSED LEVEL OF CONSCIOUSNESS † 1  1/280 (0.36%)  0/284 (0.00%) 
DIZZINESS † 1  1/280 (0.36%)  0/284 (0.00%) 
EPILEPSY † 1  1/280 (0.36%)  0/284 (0.00%) 
HEMIPARESIS † 1  1/280 (0.36%)  1/284 (0.35%) 
LOSS OF CONSCIOUSNESS † 1  1/280 (0.36%)  0/284 (0.00%) 
NEURALGIA † 1  1/280 (0.36%)  0/284 (0.00%) 
NEUROLOGICAL DECOMPENSATION † 1  1/280 (0.36%)  0/284 (0.00%) 
PARAESTHESIA † 1  0/280 (0.00%)  1/284 (0.35%) 
PRESYNCOPE † 1  1/280 (0.36%)  0/284 (0.00%) 
SCIATICA † 1  1/280 (0.36%)  0/284 (0.00%) 
SPINAL CORD COMPRESSION † 1  2/280 (0.71%)  2/284 (0.70%) 
SYNCOPE † 1  2/280 (0.71%)  1/284 (0.35%) 
TRANSIENT ISCHAEMIC ATTACK † 1  1/280 (0.36%)  0/284 (0.00%) 
EPIDURITIS † 1  1/280 (0.36%)  0/284 (0.00%) 
Psychiatric disorders     
APATHY † 1  1/280 (0.36%)  0/284 (0.00%) 
CONFUSIONAL STATE † 1  3/280 (1.07%)  2/284 (0.70%) 
DELIRIUM † 1  1/280 (0.36%)  0/284 (0.00%) 
Renal and urinary disorders     
AZOTAEMIA † 1  2/280 (0.71%)  0/284 (0.00%) 
HAEMATURIA † 1  0/280 (0.00%)  3/284 (1.06%) 
POLLAKIURIA † 1  0/280 (0.00%)  1/284 (0.35%) 
RENAL FAILURE † 1  0/280 (0.00%)  1/284 (0.35%) 
RENAL FAILURE ACUTE † 1  0/280 (0.00%)  1/284 (0.35%) 
URINARY BLADDER HAEMORRHAGE † 1  0/280 (0.00%)  1/284 (0.35%) 
URINARY INCONTINENCE † 1  1/280 (0.36%)  0/284 (0.00%) 
URINARY RETENTION † 1  1/280 (0.36%)  1/284 (0.35%) 
Reproductive system and breast disorders     
GENITAL HAEMORRHAGE † 1  0/280 (0.00%)  1/284 (0.35%) 
Respiratory, thoracic and mediastinal disorders     
ACUTE PULMONARY OEDEMA † 1  1/280 (0.36%)  0/284 (0.00%) 
ACUTE RESPIRATORY FAILURE † 1  1/280 (0.36%)  0/284 (0.00%) 
ATELECTASIS † 1  0/280 (0.00%)  1/284 (0.35%) 
BRONCHIAL OBSTRUCTION † 1  1/280 (0.36%)  0/284 (0.00%) 
COUGH † 1  1/280 (0.36%)  0/284 (0.00%) 
DYSPNOEA † 1  16/280 (5.71%)  15/284 (5.28%) 
EPISTAXIS † 1  0/280 (0.00%)  1/284 (0.35%) 
HAEMOPTYSIS † 1  0/280 (0.00%)  1/284 (0.35%) 
HYDROTHORAX † 1  1/280 (0.36%)  0/284 (0.00%) 
HYPOXIA † 1  0/280 (0.00%)  1/284 (0.35%) 
PLEURAL EFFUSION † 1  10/280 (3.57%)  10/284 (3.52%) 
PNEUMONIA ASPIRATION † 1  1/280 (0.36%)  0/284 (0.00%) 
PNEUMONITIS † 1  1/280 (0.36%)  2/284 (0.70%) 
PNEUMOTHORAX † 1  0/280 (0.00%)  1/284 (0.35%) 
PRODUCTIVE COUGH † 1  0/280 (0.00%)  1/284 (0.35%) 
PULMONARY EMBOLISM † 1  3/280 (1.07%)  0/284 (0.00%) 
RESPIRATORY ARREST † 1  1/280 (0.36%)  1/284 (0.35%) 
RESPIRATORY DISTRESS † 1  1/280 (0.36%)  0/284 (0.00%) 
RESPIRATORY FAILURE † 1  4/280 (1.43%)  3/284 (1.06%) 
HYDROPNEUMOTHORAX † 1  1/280 (0.36%)  0/284 (0.00%) 
Skin and subcutaneous tissue disorders     
ANGIOEDEMA † 1  0/280 (0.00%)  1/284 (0.35%) 
DIABETIC FOOT † 1  0/280 (0.00%)  1/284 (0.35%) 
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME † 1  0/280 (0.00%)  1/284 (0.35%) 
PRURITUS GENERALISED † 1  1/280 (0.36%)  0/284 (0.00%) 
RASH † 1  1/280 (0.36%)  0/284 (0.00%) 
RASH ERYTHEMATOUS † 1  1/280 (0.36%)  0/284 (0.00%) 
RASH GENERALISED † 1  1/280 (0.36%)  0/284 (0.00%) 
SKIN LESION † 1  0/280 (0.00%)  1/284 (0.35%) 
TOXIC EPIDERMAL NECROLYSIS † 1  0/280 (0.00%)  1/284 (0.35%) 
TOXIC SKIN ERUPTION † 1  0/280 (0.00%)  1/284 (0.35%) 
Vascular disorders     
EMBOLISM † 1  2/280 (0.71%)  0/284 (0.00%) 
HYPERTENSION † 1  0/280 (0.00%)  1/284 (0.35%) 
HYPOTENSION † 1  0/280 (0.00%)  2/284 (0.70%) 
PHLEBITIS † 1  1/280 (0.36%)  0/284 (0.00%) 
SHOCK † 1  1/280 (0.36%)  0/284 (0.00%) 
THROMBOSIS † 1  1/280 (0.36%)  0/284 (0.00%) 
VASCULAR FRAGILITY † 1  1/280 (0.36%)  0/284 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dovitinib Sorafenib
Affected / at Risk (%) Affected / at Risk (%)
Total   268/280 (95.71%)   271/284 (95.42%) 
Blood and lymphatic system disorders     
ANAEMIA † 1  27/280 (9.64%)  28/284 (9.86%) 
Endocrine disorders     
HYPOTHYROIDISM † 1  14/280 (5.00%)  8/284 (2.82%) 
Eye disorders     
LACRIMATION INCREASED † 1  19/280 (6.79%)  2/284 (0.70%) 
Gastrointestinal disorders     
ABDOMINAL PAIN † 1  34/280 (12.14%)  37/284 (13.03%) 
ABDOMINAL PAIN UPPER † 1  28/280 (10.00%)  23/284 (8.10%) 
CONSTIPATION † 1  49/280 (17.50%)  67/284 (23.59%) 
DIARRHOEA † 1  184/280 (65.71%)  126/284 (44.37%) 
DRY MOUTH † 1  23/280 (8.21%)  12/284 (4.23%) 
DYSPEPSIA † 1  30/280 (10.71%)  14/284 (4.93%) 
NAUSEA † 1  146/280 (52.14%)  81/284 (28.52%) 
STOMATITIS † 1  31/280 (11.07%)  53/284 (18.66%) 
VOMITING † 1  120/280 (42.86%)  44/284 (15.49%) 
General disorders     
ASTHENIA † 1  63/280 (22.50%)  44/284 (15.49%) 
FATIGUE † 1  113/280 (40.36%)  94/284 (33.10%) 
NON-CARDIAC CHEST PAIN † 1  22/280 (7.86%)  18/284 (6.34%) 
OEDEMA PERIPHERAL † 1  26/280 (9.29%)  17/284 (5.99%) 
PYREXIA † 1  40/280 (14.29%)  37/284 (13.03%) 
Investigations     
BLOOD ALKALINE PHOSPHATASE INCREASED † 1  25/280 (8.93%)  5/284 (1.76%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED † 1  25/280 (8.93%)  8/284 (2.82%) 
LIPASE INCREASED † 1  16/280 (5.71%)  11/284 (3.87%) 
WEIGHT DECREASED † 1  61/280 (21.79%)  87/284 (30.63%) 
Metabolism and nutrition disorders     
DECREASED APPETITE † 1  90/280 (32.14%)  96/284 (33.80%) 
HYPERTRIGLYCERIDAEMIA † 1  55/280 (19.64%)  2/284 (0.70%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA † 1  26/280 (9.29%)  26/284 (9.15%) 
BACK PAIN † 1  37/280 (13.21%)  32/284 (11.27%) 
MUSCLE SPASMS † 1  18/280 (6.43%)  24/284 (8.45%) 
MUSCULAR WEAKNESS † 1  15/280 (5.36%)  6/284 (2.11%) 
MUSCULOSKELETAL CHEST PAIN † 1  15/280 (5.36%)  13/284 (4.58%) 
MYALGIA † 1  27/280 (9.64%)  17/284 (5.99%) 
PAIN IN EXTREMITY † 1  35/280 (12.50%)  29/284 (10.21%) 
Nervous system disorders     
DIZZINESS † 1  27/280 (9.64%)  7/284 (2.46%) 
DYSGEUSIA † 1  31/280 (11.07%)  8/284 (2.82%) 
HEADACHE † 1  26/280 (9.29%)  24/284 (8.45%) 
Psychiatric disorders     
INSOMNIA † 1  15/280 (5.36%)  19/284 (6.69%) 
Respiratory, thoracic and mediastinal disorders     
COUGH † 1  50/280 (17.86%)  48/284 (16.90%) 
DYSPHONIA † 1  22/280 (7.86%)  25/284 (8.80%) 
DYSPNOEA † 1  51/280 (18.21%)  48/284 (16.90%) 
Skin and subcutaneous tissue disorders     
ALOPECIA † 1  2/280 (0.71%)  61/284 (21.48%) 
DERMATITIS ACNEIFORM † 1  23/280 (8.21%)  6/284 (2.11%) 
DRY SKIN † 1  22/280 (7.86%)  26/284 (9.15%) 
ERYTHEMA † 1  1/280 (0.36%)  15/284 (5.28%) 
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME † 1  32/280 (11.43%)  114/284 (40.14%) 
PRURITUS † 1  15/280 (5.36%)  30/284 (10.56%) 
RASH † 1  54/280 (19.29%)  47/284 (16.55%) 
Vascular disorders     
HYPERTENSION † 1  54/280 (19.29%)  78/284 (27.46%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: trialandresults.registry@novartis.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01223027    
Other Study ID Numbers: CTKI258A2302
2009-015459-25 ( EudraCT Number )
First Submitted: September 30, 2010
First Posted: October 18, 2010
Results First Submitted: June 29, 2015
Results First Posted: November 6, 2015
Last Update Posted: December 7, 2015