Trial · NCT00664326
A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC
NCT00664326, Phase 2, Completed, Bayer; results first posted 2012-11-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC. Trials, record NCT00664326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00664326
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC
- NCT number
- NCT00664326
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 49 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Carcinoma, Renal Cell
- Interventions
- Regorafenib (Stivarga, BAY73-4506)
- First posted
- 2008-04-22
- Last updated
- 2021-01-29
- Other registries' IDs
- eudract:2008-000107-28
- Results first posted
- 2012-11-28
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Tumor Response | From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks | Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response \[CR, tumor disappears\] or Partial Response \[PR, sum of lesion sizes decreased at least 30% from baseline\]) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) committee. |
| Primary | Tumor Response | From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks | Tumor response of a participant was defined as the best tumor response (confirmed Complete Response \[CR, tumor disappears\], Partial Response \[PR, sum of lesion sizes decreased at least 30% from baseline\], Stable Disease \[SD, steady state of disease\], or Progressive Disease \[PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions\]) observed during trial period assessed according to the RECIST committee. |
| Secondary | Disease Control | From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks | Disease control was defined as the percentage of participants who had a best response rating of CR (tumor disappears), PR (sum of lesion sizes decreased at least 30% from baseline), or SD (steady state of disease) that was maintained for at least 28 days from the first demonstration of that rating. |
| Secondary | Overall Survival | From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). | Overall survival (OS) was calculated as the time from the first date of receiving study medication to death, due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up. |
| Secondary | Progression-free Survival (PFS) | From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks | PFS was calculated as time from first date of receiving study drug until date of first observed disease progression (PD) (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before PD was documented. The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD or death at time of analysis were censored at last date of tumor evaluation. |
| Secondary | Time to Progression (TTP) | From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks | TTP was calculated as time from first date of receiving study drug until date of first documented disease progression (PD) (radiological or clinical, whichever was earlier). The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than the scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD at time of analysis were censored at last date of tumor evaluation. |
| Secondary | Duration of Response | From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks | Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. |
| Secondary | Duration of Stable Disease (SD) | From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks | Duration of SD was calculated as the time from the first date of receiving study drug until the date of documented PD or the last observation if the subject did not progress. Subjects without disease progression at the time of analysis were censored at the last date of tumor evaluation. |
| Other | Objective Tumor Response (Update) | From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks | Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response \[CR, tumor disappears\] or Partial Response \[PR, sum of lesion sizes decreased at least 30% from baseline\]) observed during trial period assessed according to the RECIST committee. |
| Other | Tumor Response (Update) | From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks | Tumor response of a participant was defined as the best tumor response (confirmed Complete Response \[CR, tumor disappears\], Partial Response \[PR, sum of lesion sizes decreased at least 30% from baseline\], Stable Disease \[SD, steady state of disease\], or Progressive Disease \[PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions\]) observed during trial period assessed according to the RECIST committee. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Tumor Response | From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks | Evaluable for response (Primary analysis population) | Percentage of participants | NUMBER |
| PRIMARY | Tumor Response | From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks | Evaluable for response (Primary analysis population) | Percentage of participants | NUMBER |
| SECONDARY | Disease Control | From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks | Evaluable for response (Primary analysis population) | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival | From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). | intention-to-treat (ITT) | Days | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks | intention-to-treat (ITT) | Days | MEDIAN |
| SECONDARY | Time to Progression (TTP) | From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks | intention-to-treat (ITT) | Days | MEDIAN |
| SECONDARY | Duration of Response | From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks | Only subjects from ITT population with a response of CR or PR were included in this evaluation. | Days | MEDIAN |
| SECONDARY | Duration of Stable Disease (SD) | From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks | Subjects from ITT population who achieved objective response of CR or PR were excluded from this evaluation. | Days | MEDIAN |
| OTHER_PRE_SPECIFIED | Objective Tumor Response (Update) | From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks | Evaluable for response (Primary analysis population) | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Tumor Response (Update) | From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks | Evaluable for response (Primary analysis population) | Percentage of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Tumor Response | Regorafenib (Stivarga, BAY73-4506) | 31.3 | Percentage of participants | ||
| Tumor Response | Regorafenib (Stivarga, BAY73-4506) | Complete Response (CR) | 0.0 | Percentage of participants | |
| Tumor Response | Regorafenib (Stivarga, BAY73-4506) | Partial Response (PR) | 31.3 | Percentage of participants | |
| Tumor Response | Regorafenib (Stivarga, BAY73-4506) | Stable Disease (SD) | 50.0 | Percentage of participants | |
| Tumor Response | Regorafenib (Stivarga, BAY73-4506) | Progressive Disease (PD) | 10.4 | Percentage of participants | |
| Tumor Response | Regorafenib (Stivarga, BAY73-4506) | Not Assessable | 8.3 | Percentage of participants | |
| Disease Control | Regorafenib (Stivarga, BAY73-4506) | 62.5 | Percentage of participants | ||
| Overall Survival | Regorafenib (Stivarga, BAY73-4506) | NA | 95% Confidence Interval 285 to NA | Days | |
| Progression-free Survival (PFS) | Regorafenib (Stivarga, BAY73-4506) | 251 | 95% Confidence Interval 160 to NA | Days | |
| Time to Progression (TTP) | Regorafenib (Stivarga, BAY73-4506) | 251 | 95% Confidence Interval 167 to NA | Days |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regorafenib (Stivarga, BAY73-4506) | 49 | |
| Overall Study | COMPLETED | Regorafenib (Stivarga, BAY73-4506) | 1 | |
| Overall Study | NOT COMPLETED | Regorafenib (Stivarga, BAY73-4506) | 48 |
Source ClinicalTrials.gov
Adverse events115
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 | Regorafenib (BAY73-4506) | 5 | 49 | 9 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Regorafenib (BAY73-4506) | 5 | 49 | 11 |
| other | Abdominal pain | Gastrointestinal disorders | Regorafenib (BAY73-4506) | 13 | 49 | 37 |
| other | Abdominal pain upper | Gastrointestinal disorders | Regorafenib (BAY73-4506) | 8 | 49 | 28 |
| other | Constipation | Gastrointestinal disorders | Regorafenib (BAY73-4506) | 17 | 49 | 112 |
| other | Diarrhoea | Gastrointestinal disorders | Regorafenib (BAY73-4506) | 24 | 49 | 215 |
| other | Dyspepsia | Gastrointestinal disorders | Regorafenib (BAY73-4506) | 6 | 49 | 7 |
| other | Dysphagia | Gastrointestinal disorders | Regorafenib (BAY73-4506) | 4 | 49 | 5 |
| other | Glossodynia | Gastrointestinal disorders | Regorafenib (BAY73-4506) | 3 | 49 | 4 |
| other | Nausea | Gastrointestinal disorders | Regorafenib (BAY73-4506) | 16 | 49 | 46 |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regorafenib (BAY73-4506) | 39 | 49 |
| Total, other adverse events | Regorafenib (BAY73-4506) | 48 | 49 |
| Total, serious adverse events | Regorafenib (BAY73-4506) | 32 | 49 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22959186 | RESULT |
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 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.
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/NCT00664326
GET https://conductscience.org/api/trials/v1/NCT00664326/results?page=2