Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Participants, received RAD001 10 mg orally once daily.

Study drug was supplied as 5 mg tablets in blister packs.

RAD001

Novartis Pharmaceuticals

This study will evaluate everolimus as second-line therapy in patients with metastatic renal cell carcinoma. Each patient will be enrolled and stratified in one of three cohorts based upon their first-line therapy: 1) prior cytokines, 2) prior sunitinib, or 3) prior anti-VEGF therapy other than sunitinib.

Everolimus as Second-line Therapy in Metastatic Renal Cell Carcinoma

An Open-label, Multicenter Phase II Study to Examine the Efficacy and Safety of Everolimus as Second-line Therapy in the Treatment of Patients With Metastatic Renal Cell Carcinoma

PFS during second-line treatment was defined as the time from the date of enrollment to the date of the first documented disease progression or death due to any cause. The primary analysis of PFS was based on a local radiology review of CT scans and MRI collected until the participant experienced disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0.

Duration of PFS during second-line treatment was defined as the time from the date of enrollment to the date of the first documented disease progression or death due to any cause. Participants' assessment was based on the local radiological data according to the RECIST 1.0 Criteria.

OS was defined as the time from date of enrollment to date of death due to any cause.

CBR was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) or stable disease based on the local radiological data according to the RECIST 1.0 criteria.

ORR was defined as the proportion of participants with best overall response of CR or PR based on the local radiological data according to the RECIST 1.0 Criteria

DoR was defined as the time from the first occurrence of PR or CR (as per local radiological review) until the date of the first documented disease progression or death due to underlying cancer.

Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.

Prior Sunitinib

Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.

Other Prior Anti VEGF

Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.

Prior Cytokines

Other Prior Vascular Endothelial Growth Factor (VEGF)

Total

Age, Continuous

Sex: Female, Male

Study Director

All participants received RAD001 10 mg daily.

All Participants

The full analysis set (FAS) was used. It included all enrolled participants.

Progression-free Survival (PFS) - All Participants

The FAS was used. It included all enrolled participants.

Duration of PFS for Each First-line Treatment Cohort

Overall Survival (OS)

Clinical Benefit Rate (CBR)

Objective Response Rate (ORR)

The FAS was considered for this analysis. The FAS included all enrolled participants. Only participants who achieved a CR or PR were analyzed. Therefore, actual n=4,3,3,10.

Spots Global Cancer Trial Database for Everolimus as Second-line Therapy in Metastatic Renal Cell Carcinoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial