Long-term Extension From RCC Phase II (11515)
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
386 | — |
| SECONDARY Best Tumor Response |
0; 25; 64; 4; 1 | — |
| SECONDARY Overall Survival (OS) |
— | — |
| SECONDARY Overall Response Duration |
419 | — |
| SECONDARY Time to Objective Response |
84 | — |
| SECONDARY Overall Disease Control |
81 | — |
Eligibility Criteria
Inclusion Criteria
Patients are classified into two groups as below at transition date from Study 11515 to this study.
Population I: Patients who are willing to continue the study drug, for whom the investigator consider continuation of the study drug is appropriate, and who do not meet the criteria of removal from the study in Study 11515 at the end of Study 11515.
Population II: Patients who have been monitored only for survival status at the end of Study 11515.
Population 1
- Patients who are willing to continue the study drug,
- Patients for whom the investigator consider continuation of the study drug is appropriate
- Patients who do not meet the criteria of removal from the study in Study 11515 at the end of Study 11515.
- Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Population 2
- Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Exclusion Criteria
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Any condition that could jeopardize the safety of the patient or that affect his/her compliance in the study
- Pregnant or breast-feeding patients. Both men and women enrolled in this trial must use adequate birth control.
Data sourced from ClinicalTrials.gov (NCT00586495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.