Trial · NCT01223027
Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma
NCT01223027, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2015-11-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma. Trials, record NCT01223027. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01223027
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma
- NCT number
- NCT01223027
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 564 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Metastatic Renal Cell Carcinoma
- Interventions
- Dovitinib, Sorafenib
- First posted
- 2010-10-18
- Last updated
- 2015-12-07
- Other registries' IDs
- eudract:2009-015459-25
- Results first posted
- 2015-11-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) Per Independent Central Radiology Review | Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation) | 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. |
| Secondary | Overall Survival (OS) | until at least 386 deaths are documented in the clinical database. | 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. |
| Secondary | Progression Free Survival (PFS) Per Investigator's Radiology Review | Until disease progression or discontinuation of treatment due to unacceptable toxicity | 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. |
| Secondary | Percentage of Participants With Overall Response Rate (ORR) by Central Radiology Review | Until disease progression or discontinuation of treatment due to unacceptable toxicity | 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). |
| Secondary | Time to Definitive Worsening of Karnofsky Performance Status (KPS) | from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier | 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. |
| Secondary | 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 | from date of randomization, at least 2 score units | 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). |
| Secondary | Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Physical Functioning (PF) Scale of EORTC QLQ-C30 by at Least 10% | from date of randomization | 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. |
| Secondary | Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Quality of Life (QoL) Scale Scores of EORTC QLQ-C30 by at Least 10% | from date of randomization | 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. |
| Secondary | Pre-dose Concentration in Plasma in Dovitinib | Week 2 Day 5, Week 4 Day 5, Week 6 Day 5 | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) Per Independent Central Radiology Review | Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation) | Full Analysis Set (FAS) consisted of all randomized patients. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | until at least 386 deaths are documented in the clinical database. | Full Analysis Set (FAS) consisted of all randomized patients. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Per Investigator's Radiology Review | Until disease progression or discontinuation of treatment due to unacceptable toxicity | Full Analysis Set (FAS) consisted of all randomized patients. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Overall Response Rate (ORR) by Central Radiology Review | Until disease progression or discontinuation of treatment due to unacceptable toxicity | Full Analysis Set (FAS) consisted of all randomized patients. | Percentage of Participants | NUMBER |
| SECONDARY | Time to Definitive Worsening of Karnofsky Performance Status (KPS) | from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier | Full Analysis Set (FAS) consited of all randomized patients. | Months | MEDIAN |
| SECONDARY | 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 | from date of randomization, at least 2 score units | Full Analysis Set (FAS) consisted of all randomized patients. | Months | MEDIAN |
| SECONDARY | Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Physical Functioning (PF) Scale of EORTC QLQ-C30 by at Least 10% | from date of randomization | Full Analysis Set (FAS) consisted of all randomized patients. | Months | MEDIAN |
| SECONDARY | Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Quality of Life (QoL) Scale Scores of EORTC QLQ-C30 by at Least 10% | from date of randomization | Full Analysis Set (FAS) consisted of all randomized patients. | Months | MEDIAN |
| SECONDARY | Pre-dose Concentration in Plasma in Dovitinib | Week 2 Day 5, Week 4 Day 5, Week 6 Day 5 | 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. | ng/ml | MEAN |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) Per Independent Central Radiology Review | Dovitinib + Best Supportive Care (BSC) | 3.7 | 95% Confidence Interval 3.5 to 3.9 | Months | |
| Progression Free Survival (PFS) Per Independent Central Radiology Review | Sorafenib + BSC | 3.6 | 95% Confidence Interval 3.5 to 3.7 | Months | |
| Overall Survival (OS) | Dovitinib + Best Supportive Care (BSC) | 11.1 | 95% Confidence Interval 9.5 to 13.4 | Months | |
| Overall Survival (OS) | Sorafenib + BSC | 11.0 | 95% Confidence Interval 8.6 to 13.5 | Months | |
| Progression Free Survival (PFS) Per Investigator's Radiology Review | Dovitinib + Best Supportive Care (BSC) | 3.9 | 95% Confidence Interval 3.7 to 5.1 | Months | |
| Progression Free Survival (PFS) Per Investigator's Radiology Review | Sorafenib + BSC | 3.9 | 95% Confidence Interval 3.7 to 5.0 | Months | |
| Percentage of Participants With Overall Response Rate (ORR) by Central Radiology Review | Dovitinib + Best Supportive Care (BSC) | 3.9 | Percentage of Participants | ||
| Percentage of Participants With Overall Response Rate (ORR) by Central Radiology Review | Sorafenib + BSC | 3.8 | Percentage of Participants | ||
| Time to Definitive Worsening of Karnofsky Performance Status (KPS) | Dovitinib + Best Supportive Care (BSC) | 5.1 | 95% Confidence Interval 3.8 to 6.5 | Months | |
| Time to Definitive Worsening of Karnofsky Performance Status (KPS) | Sorafenib + BSC | 5.7 | 95% Confidence Interval 4.6 to 7.4 | Months |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dovitinib + Best Supportive Care (BSC) | 284 | |
| Overall Study | STARTED | Sorafenib + BSC | 286 | |
| Overall Study | COMPLETED | Dovitinib + Best Supportive Care (BSC) | 10 | |
| Overall Study | COMPLETED | Sorafenib + BSC | 9 | |
| Overall Study | NOT COMPLETED | Dovitinib + Best Supportive Care (BSC) | 274 | |
| Overall Study | NOT COMPLETED | Sorafenib + BSC | 277 |
Source ClinicalTrials.gov
Adverse events516
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Dovitinib | 27 | 280 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Sorafenib | 28 | 284 | |
| other | HYPOTHYROIDISM | Endocrine disorders | Dovitinib | 14 | 280 | |
| other | HYPOTHYROIDISM | Endocrine disorders | Sorafenib | 8 | 284 | |
| other | LACRIMATION INCREASED | Eye disorders | Dovitinib | 19 | 280 | |
| other | LACRIMATION INCREASED | Eye disorders | Sorafenib | 2 | 284 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Dovitinib | 34 | 280 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Sorafenib | 37 | 284 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Dovitinib | 28 | 280 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Sorafenib | 23 | 284 |
1 to 10 of 516Source ClinicalTrials.gov
See all 516 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dovitinib | ||
| Total, all-cause mortality | Sorafenib | ||
| Total, other adverse events | Dovitinib | 268 | 280 |
| Total, other adverse events | Sorafenib | 271 | 284 |
| Total, serious adverse events | Dovitinib | 133 | 280 |
| Total, serious adverse events | Sorafenib | 112 | 284 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24556040 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dovitinib vs Sorafenib: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01223027
GET https://conductscience.org/api/trials/v1/NCT01223027/events?page=2