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:
Bayer
ClinicalTrials.gov Identifier:
NCT00664326
First received: April 17, 2008
Last updated: April 16, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
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
| 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 ] |
| 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 ] |