Phase 4
Completed N=29
Safety and Efficacy of Everolimus in Metastatic Renal Cell Carcinoma After Failure of First Line Therapy With Sunitinib or Pazopanib
Source: ClinicalTrials.gov NCT01514448 ↗Enrolled (actual)
29
Serious AEs
48.3%
Results posted
Jul 2017
Primary outcomePrimary: Percentage of Progression-free Patients by Month 6 — 8.3; 46.2 Percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Patients with metastatic renal cell carcinoma (mRCC) who failed first-line therapy with sunitinib or pazopanib was treated with everolimus. Efficacy and safety of everolimus was evaluated in these patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Progression-free Patients by Month 6 |
8.3; 46.2 | — |
| SECONDARY Percentage of Patients With Overall Response Rate (ORR) Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy at Month 6 |
0.0; 0.0 | — |
| SECONDARY Progression-Free Survival (PFS) as the Time Interval Between First Intake of Everolimus and First Documented Disease Progression or Death Due to Any Cause at 24 Months |
2.8; 8.0 | — |
| SECONDARY Overall Survival (OS) of Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months |
14.8; 20.4 | — |
| SECONDARY Duration of Response (DOR) in Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients with advanced renal cell carcinoma of a histological or cytological confirmation of clear cell renal carcinoma.
- Progression during or after a treatment with sunitinib or pazopanib given in a 1st line treatment situation for mRCC.
- Patients scheduled for treatment with everolimus.
- Patients with at least one measurable lesion at baseline as per RECIST v1.1.
Exclusion Criteria
- Patients who have received >1 prior systemic treatment for their metastatic RCC. Prior systemic treatment in an adjuvant setting is allowed.
- Patients who have previously received systemic mTOR inhibitors (e.g. sirolimus, temsirolimus, everolimus).
- Patients who are using other investigational agents or who had received investigational drugs ≤ 2 weeks prior to study treatment start.
- Patients unwilling or unable to comply with the protocol.
Data sourced from ClinicalTrials.gov (NCT01514448). 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.