Locally Advanced and/or Metastatic Renal Cell Carcinoma MedDRA version: 14.1 Level: PT Classification code 10050513 Term: Metastatic renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Section deemed no longer required and removed from the protocol by amendment No 5 (please refer to Section 11 the Appendix 7 of the protocol amendment No 5). Enrolment is complete and the study has been reported. This study remains open to allow subjects currently on treatment continued access to their treatment (as determined by the investigator). No new subjects will be entered. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 532 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 395
Exclusion criteria
Exclusion criteria: Section deemed no longer required and removed from the protocol by amendment No 5 (please refer to Section 11 the Appendix 7 of the protocol amendment No 5). Enrolment is complete and the study has been reported. This study remains open to allow subjects currently on treatment continued access to their treatment (as determined by the investigator). No new subjects will be entered.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This Phase III study, VEG108844, has met and reported its primary and key secondary efficacy and safety objectives. An updated OS analysis is planned with a data cut-off of 30 September 2013. The study is being kept open beyond the completion and reporting of the primary and key secondary objectives to enable subjects currently on treatment with pazopanib or sunitinib to have continued access to their treatment until the occurrence of unacceptable toxicity, disease progression (as determined by the investigator), or other reason for withdrawal from treatment, and to discontinue collection of many studyspecific assessments. ;Secondary Objective: This Phase III study, VEG108844, has met and reported its primary and key secondary efficacy and safety objectives. An updated OS analysis is planned with a data cut-off of 30 September 2013. The study is being kept open beyond the completion and reporting of the primary and key secondary objectives to enable subjects currently on treatment with pazopanib or sunitinib to have continued access to their treatment until the occurrence of unacceptable toxicity, disease progression (as determined by the investigator), or other reason for withdrawal from treatment, and to discontinue collection of many studyspecific assessments. ;Primary end point(s): Section deemed no longer required and removed from the protocol by amendment No 5 (please refer to Section 11 the Appendix 7 of the protocol amendment No 5). Enrolment is complete and the study has been reported. ;Timepoint(s) of evaluation of this end point: Section deemed no longer required and removed from the protocol by amendment No 5 (please refer to Section 11 the Appendix 7 of the protocol amendment No 5). Enrolment is complete and the study has been reported. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Section deemed no longer required and removed from the protocol by amendment No 5 (please refer to Section 11 the Appendix 7 of the protocol amendment No 5). Enrolment is complete and the study has been reported. ;Timepoint(s) of evaluation of this end point: Section deemed no longer required and removed from the protocol by amendment No 5 (please refer to Section 11 the Appendix 7 of the protocol amendment No 5). Enrolment is complete and the study has been reported. | — |
Countries
Australia, Canada, China, Germany, Ireland, Italy, Japan, Korea, Republic of, Netherlands, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
GlaxoSmithKline Research & Development Ltd