Efficacy and Safety of Everolimus in Patients with Unresectable or Metastatic Renal Cell Carcinoma

Efficacy and Safety of Everolimus in Patients with Unresectable or Metastatic Renal Cell Carcinoma - Efficacy and Safety of Everolimus in Patients with Unresectable or Metastatic Renal Cell Carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000008769

Enrollment

120

Registered

2012-10-01

Start date

2012-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal cell carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with unresectable or metastatic renal cell carcinoma who have confirmed histological or cytological diagnosis of clear cell renal cell carcinoma 2) Patients who have at least one measurable foci on CT or MRI 3) 18 years old or older 4) ECOG PS 0-1 5) No interstitial pneumonia on the lungs observed on chest CT

Exclusion criteria

Exclusion criteria: 1) Patients with history of hypersensitivity against everolimus or sirolimus derivative 2) Pregnant, pregnancy suspect, nursing women, patients who plan to have a baby 3) Patients judged ineligible to participate in the study by the investigator

Design outcomes

Primary

Measure	Time frame
Progression-free Survival, PFS	—

Secondary

Measure	Time frame
1) Overall survival from the initiation of everolimus treatment 2) ORR 3) TTF 4) Safety profile 5) predictive factors prognotic factors	—

Countries

Japan

Contacts

Public ContactRyuichi Mizuno

Keio University School of Medicine Department of Urology

mizunor@z7.keio.jp(03)3353-1211

Outcome results