Ignite Creation Date:
2024-05-05 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00732914
Status:
COMPLETED
Last Update Posted:
2014-04-23
First Post:
2008-08-11
Brief Title:
Sequential Study to Treat Renal Cell Carcinoma
Sponsor:
Sponsor GmbH
Organization:
Sponsor GmbH
Study Overview
Official Title:
A Phase III Randomized Sequential Open-Label Study to Evaluate the Efficacy and Safety of Sorafenib Followed by Sunitinib Versus Sunitinib Followed by Sorafenib in the Treatment of First-Line Advanced Metastatic Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary
To evaluate if progression-free survival from first treatment to progression or death during second-line therapy total PFS of sorafenib followed by sunitinib is superior compared to sunitinib followed by sorafenib
Secondary
1 Time from first treatment to progression during second-line therapy total TTP
2 Time to first-line treatment failure progression death discontinuation due to toxicity descriptively in each arm
3 PFS in first-line and second-line treatment descriptively
4 Overall survival descriptively data cut-off same as for primary endpoint
5 Disease Control Rate DCR Response rates in first-line and in second-line CR PR SD according to RECIST criteria
6 Cardiotoxicity analysis by means of echocardiography and NT-pro BNP with an interim analysis after 100 patients of each arm have completed the study
7 Safety and tolerability
To evaluate if progression-free survival from first treatment to progression or death during second-line therapy total PFS of sorafenib followed by sunitinib is superior compared to sunitinib followed by sorafenib
Secondary
1 Time from first treatment to progression during second-line therapy total TTP
2 Time to first-line treatment failure progression death discontinuation due to toxicity descriptively in each arm
3 PFS in first-line and second-line treatment descriptively
4 Overall survival descriptively data cut-off same as for primary endpoint
5 Disease Control Rate DCR Response rates in first-line and in second-line CR PR SD according to RECIST criteria
6 Cardiotoxicity analysis by means of echocardiography and NT-pro BNP with an interim analysis after 100 patients of each arm have completed the study
7 Safety and tolerability
Detailed Description:
The results of three sequential retrospective studies Sablin et al ASCO 2007 Dham et al ASCO 2007 and Tamaskar et al 2008 support the sequential administration of sorafenib and sunitinib even though these two drugs have an overlap of targets These results suggest the lack of cross resistance between sorafenib and sunitinib This study is a sequential randomized open-label 11 multicenter phase III study starting in first-line of metastatic advanced RCC using in the experimental arm sorafenib until progression followed by sunitinib and in the control arm sunitinib until progression followed by sorafenib Sorafenib-patients will switch to sunitinib and vice versa with a treatment-free period of at least one and up to maximum four weeks after confirmed first-line treatment failure in order to avoid additive toxicity In general the first-line treatment should be continued until progression RECIST However if patients do not tolerate the first-line medication sorafenib or sunitinib because of toxicity they may cross-over to the second-line therapy sunitinib or sorafenib despite the lack of progression if an appropriate attempt according to a specific dose reduction interruption scheme has been made to cope with the toxicity and try to resume first line therapy if deemed appropriate with a reduced dose In case of discontinuation of first-line treatment because of toxicity patients will be enrolled for the second-line treatment only after nonhematological toxicity has resolved to grade 1 and hematological toxicity to grade 2 As an exception patients who refuse to be treated further with the first-line regimen due to intolerability despite having no progression may be crossed over to the second-line treatment if they consent and are in general compliance Any crossover also without progression requires a CT scan which is in this case also considered the baseline scan for the second-line treatment One cycle is of six weeks duration Patients will undergo a CTMRI scan after every second cycle ie after 12 weeks each which will be evaluated according to RECIST criteria There will be no continuation of the same study medication beyond progression in both first- or second-line therapy After the study reached its primary endpoint cut off ie after 194 endpoint events have occurred clean data for these patients exist and a statistical analysis has been performed data collection will be stopped After that the trial is terminated and a close out visit will be performed Remaining patients will be treated outside the study and will be censored in the analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT 2008-005011-18 | None | None | None |