A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC
This study is ongoing, but not recruiting participants.
Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00664326
First received: April 17, 2008
Last updated: February 3, 2015
Last verified: February 2015
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Results First Received: October 28, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Carcinoma, Renal Cell |
| Intervention: |
Drug: Regorafenib (Stivarga, BAY73-4506) |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Male or female untreated participants, who were at least 18 years of age, with metastatic and/or unresectable, measurable predominantly clear cell renal cell cancer (RCC) histologically or cytologically documented could participate in this study at 18 centers in 6 countries. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Of 64 enrolled participants, 49 received study medication, and 15 were screen failures due to protocol violation (12 participants), withdrawal of consent (1 participant), adverse event (2 participants). |
Reporting Groups
| Description | |
|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle |
Participant Flow: Overall Study
| Regorafenib (Stivarga, BAY73-4506) | |
|---|---|
| STARTED | 49 |
| COMPLETED | 25 |
| NOT COMPLETED | 24 |
| Adverse Event | 13 |
| Noncompliance with study medication | 3 |
| Withdrawal by Subject | 1 |
| Physician Decision | 1 |
| ongoing with treatment | 6 |
Baseline Characteristics
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle |
Baseline Measures
| Regorafenib (Stivarga, BAY73-4506) | |
|---|---|
|
Number of Participants
[units: participants] |
49 |
|
Age
[units: Years] Median ( Full Range ) |
62.0
( 40 to 76 ) |
|
Gender
[units: Participants] |
|
| Female | 22 |
| Male | 27 |
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
[1] [units: Participants] |
|
| 0 | 30 |
| 1 | 19 |
|
Overall Motzer Score
[2] [units: Participants] |
|
| Low | 24 |
| Intermediate | 25 |
| [1] | The ECOG PS ranged from Grades 0 to 5 (death). Grade 0 (fully active, able to carry on all pre-diseases performance without restriction) and Grade 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) were inclusion criteria. |
|---|---|
| [2] | The Motzer score (high/poor risk, intermediate risk, low risk) is based on the number of the following poor prognostic features a participant possessed: ECOG >2, serum lactate dehydrogenase concentration > 1.5 times the upper limit of normal, hemoglobin < lower limit of normal, corrected calcium concentration > 10 mg/dl, and absence of prior nephrectomy. Participants who had none of these features = low risk; participants with 1 or 2 of these features = intermediate risk; participants with 3 or more of these features = high/poor risk and were excluded from participating in the study. |
Outcome Measures
Show All Outcome Measures
| 1. Primary: | Objective Tumor Response [ Time Frame: 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 ] |
| 2. Primary: | Tumor Response [ Time Frame: 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 ] |
| 3. Secondary: | Disease Control [ Time Frame: 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 ] |
| 4. Secondary: | Overall Survival [ Time Frame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). ] |
| 5. Secondary: | Progression-free Survival (PFS) [ Time Frame: 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 ] |
| 6. Secondary: | Time to Progression (TTP) [ Time Frame: 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 ] |
| 7. Secondary: | Duration of Response [ Time Frame: 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 ] |
| 8. Secondary: | Duration of Stable Disease (SD) [ Time Frame: 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 ] |
| 9. Other Pre-specified: | Objective Tumor Response (Update) [ Time Frame: 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 ] |
| 10. Other Pre-specified: | Tumor Response (Update) [ Time Frame: 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 ] |
| 11. Other Pre-specified: | Disease Control (Update) [ Time Frame: 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 ] |
| 12. Other Pre-specified: | Overall Survival (Update) [ Time Frame: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). ] |
| 13. Other Pre-specified: | Progression-free Survival (Update) [ Time Frame: 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 ] |
| 14. Other Pre-specified: | Time to Progression (Update) [ Time Frame: 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 ] |
Hide Outcome Measure 14
| Measure Type | Other Pre-specified |
|---|---|
| Measure Title | Time to Progression (Update) |
| Measure Description | 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. |
| Time Frame | 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 |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| intention-to-treat (ITT) |
Reporting Groups
| Description | |
|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle |
Measured Values
| Regorafenib (Stivarga, BAY73-4506) | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
49 |
|
Time to Progression (Update)
[units: Days] Median ( 95% Confidence Interval ) |
335
( 167 to 454 ) |
No statistical analysis provided for Time to Progression (Update)
| 15. Other Pre-specified: | Duration of Response (Update) [ Time Frame: 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 ] |
| 16. Other Pre-specified: | Duration of Stable Disease (Update) [ Time Frame: 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 ] |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |