Trial · NCT00073307
Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer
NCT00073307, Phase 3, Completed, Bayer; results first posted 2011-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer. Trials, record NCT00073307. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00073307
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer
- NCT number
- NCT00073307
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 903 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Carcinoma, Renal Cell
- Interventions
- Sorafenib (Nexavar, BAY43-9006), Placebo
- First posted
- 2003-11-21
- Last updated
- 2014-02-06
- Results first posted
- 2011-12-14
- Limitations and caveats
Per final PFS data (N=769) study unblinded; placebo-randomized subjects switched to sorafenib \~31May2005 (N=216) that diluted final OS, sorafenib treatment effect. Final ITT, N=903, reported safety data include additional data and cleaning.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population | From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later | Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment. |
| Primary | Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population | From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later | Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment. |
| Secondary | Final Progression-Free Survival (PFS) - Independent Radiological Review | From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks. | PFS determined as the time (days) from the date of randomization at start of study to the actual date of disease progression (PD) (radiological or clinical) or death due to any cause, if death occurred before PD. Outcome measure was assessed approximately every 8 weeks using RECIST v1.0 criteria by independent radiologic review. Radiological PD defined as at least 20% increase in sum of longest diameter (LD) of measured lesions taking as reference smallest sum LD recorded since treatment started or appearance of new lesions. |
| Secondary | Best Overall Response - Independent Radiological Review | From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks. | Best overall response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 by independent radiologic review. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased) and not evaluated. |
| Secondary | Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment | From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment. | Primary Analysis for FKSI-10 patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FKSI-10 patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the range of values for FKSI-10 total score is from 0 to 40; higher score represents better HRQOL. |
| Secondary | Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment | From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment. | Primary Analysis for FACT-G (using PWB score) patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FACT-G (PWB score) patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the total FACT-G (PWB score) range of values is from 0 to 28; higher score represents better HRQOL. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population | From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later | Evaluations based on ITT population. Subjects alive at time of analysis were censored at last date of follow-up (FU) (last visit or contact or at data cut-off date). In case of incomplete date, day was missing, day 15 was used. | days | MEDIAN |
| PRIMARY | Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population | From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later | Evaluations based on ITT population. Subjects alive at time of analysis were censored at last date of FU (last visit or contact or at data cut-off date). In case of incomplete date, missing day, day 15 was used. Placebo censored at 30June2005, approximate time of crossover of placebo subjects to sorafenib. NA - not estimable due to censored data. | days | MEDIAN |
| SECONDARY | Final Progression-Free Survival (PFS) - Independent Radiological Review | From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks. | Evaluations based on ITT population as of 28Jan2005 data cut; 769 subjects randomized at that time. PFS determined as time from randomization to actual date of disease progression (PD) (radiological or clinical) or death, if death occurred before PD. Subjects without PD or death at time of analysis were censored at last date of tumor assessment. | days | MEDIAN |
| SECONDARY | Best Overall Response - Independent Radiological Review | From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks. | Evaluations of best overall response based on the valid for response population, where as per protocol, subjects were to have first post-baseline tumor evaluation performed at the end of Cycle 1 (6 weeks post-randomization). Of the ITT population that met this criteria as of the 28Jan2005 data cut, 672 subjects were valid for response. | percentage of participants | NUMBER |
| SECONDARY | Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment | From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment. | Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment | From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment. | Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment. | Scores on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population | Sorafenib (Nexavar, BAY43-9006) | 542 | 95% Confidence Interval 500 to 598 | days | |
| Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population | Placebo | 461 | 95% Confidence Interval 408 to 526 | days | |
| Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population | Sorafenib (Nexavar, BAY43-9006) | 542 | 95% Confidence Interval 500 to 598 | days | |
| Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population | Placebo | 436 | 95% Confidence Interval 385 to NA | days | |
| Final Progression-Free Survival (PFS) - Independent Radiological Review | Sorafenib (Nexavar, BAY43-9006) | 167 | 95% Confidence Interval 139 to 174 | days | |
| Final Progression-Free Survival (PFS) - Independent Radiological Review | Placebo | 84 | 95% Confidence Interval 78 to 91 | days | |
| Best Overall Response - Independent Radiological Review | Sorafenib (Nexavar, BAY43-9006) | Complete Response | 0.0 | percentage of participants | |
| Best Overall Response - Independent Radiological Review | Placebo | Complete Response | 0.0 | percentage of participants | |
| Best Overall Response - Independent Radiological Review | Sorafenib (Nexavar, BAY43-9006) | Partial Response | 2.1 | percentage of participants | |
| Best Overall Response - Independent Radiological Review | Placebo | Partial Response | 0.0 | percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind (DB, as of ~31May2005) | STARTED | Sorafenib (Nexavar, BAY43-9006) | 451 | |
| Double-Blind (DB, as of ~31May2005) | STARTED | Placebo | 452 | |
| Double-Blind (DB, as of ~31May2005) | STARTED | Placebo Randomized, Switch to Sorafenib; Sorafenib Period Only | 0 | |
| Double-Blind (DB, as of ~31May2005) | Participants Received Treatment | Sorafenib (Nexavar, BAY43-9006) | 451 | |
| Double-Blind (DB, as of ~31May2005) | Participants Received Treatment | Placebo | 451 | |
| Double-Blind (DB, as of ~31May2005) | Participants Received Treatment | Placebo Randomized, Switch to Sorafenib; Sorafenib Period Only | 0 | |
| Double-Blind (DB, as of ~31May2005) | COMPLETED | Sorafenib (Nexavar, BAY43-9006) | 254 | |
| Double-Blind (DB, as of ~31May2005) | COMPLETED | Placebo | 299 | |
| Double-Blind (DB, as of ~31May2005) | COMPLETED | Placebo Randomized, Switch to Sorafenib; Sorafenib Period Only | 0 | |
| Double-Blind (DB, as of ~31May2005) | NOT COMPLETED | Sorafenib (Nexavar, BAY43-9006) | 197 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events964
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 | Hemoglobin | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006)-31May2005 DB | 30 | 451 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Placebo-31May2005 DB | 29 | 451 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006)-30Jun2008 | 61 | 452 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Placebo ~31May2005, Then Switched to Sorafenib Only-30Jun2008 | 23 | 216 | |
| other | Edema: Limb | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006)-31May2005 DB | 28 | 451 | |
| other | Edema: Limb | Blood and lymphatic system disorders | Placebo-31May2005 DB | 22 | 451 | |
| other | Edema: Limb | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006)-30Jun2008 | 42 | 452 | |
| other | Edema: Limb | Blood and lymphatic system disorders | Placebo ~31May2005, Then Switched to Sorafenib Only-30Jun2008 | 16 | 216 | |
| other | Hypertension | Cardiac disorders | Sorafenib (Nexavar, BAY43-9006)-31May2005 DB | 74 | 451 | |
| other | Hypertension | Cardiac disorders | Placebo-31May2005 DB | 8 | 451 |
1 to 10 of 964Source ClinicalTrials.gov
See all 964 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sorafenib (Nexavar, BAY43-9006)-31May2005 DB | ||
| Total, all-cause mortality | Placebo-31May2005 DB | ||
| Total, all-cause mortality | Sorafenib (Nexavar, BAY43-9006)-30Jun2008 | ||
| Total, all-cause mortality | Placebo ~31May2005, Then Switched to Sorafenib Only-30Jun2008 | ||
| Total, other adverse events | Sorafenib (Nexavar, BAY43-9006)-31May2005 DB | 407 | 451 |
| Total, other adverse events | Placebo-31May2005 DB | 346 | 451 |
| Total, other adverse events | Sorafenib (Nexavar, BAY43-9006)-30Jun2008 | 425 | 452 |
| Total, other adverse events | Placebo ~31May2005, Then Switched to Sorafenib Only-30Jun2008 | 200 | 216 |
| Total, serious adverse events | Sorafenib (Nexavar, BAY43-9006)-31May2005 DB | 154 | 451 |
| Total, serious adverse events | Placebo-31May2005 DB | 110 | 451 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers13
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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Read this trial from software.
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