Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

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

Sunitinib

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.

Everolimus was used as commercially available formulated tablets of 10 mg strength

Everolimus (RAD001)

Novartis Pharmaceuticals

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.

Safety and Efficacy of Everolimus in Metastatic Renal Cell Carcinoma After Failure of First Line Therapy With Sunitinib or Pazopanib

An Open Label, Single Arm Trial to Evaluate Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus After Failure of First Line Therapy With Sunitinib or Pazopanib

Percentage of progression-free patients by month 6 after starting everolimus treatment. For the purpose of the binomial design of the study, a patient being 'progression-free' will be defined as a patient without disease progression by month 6 whereas a subject with progressive disease by month 6 will not be counted as 'progression-free'. The primary variable was derived from radiologic tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) Disease progression was either 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline (minimum absolute increase 5 mm in sum) or 2) the appearance of a new lesion or 3) the unequivocal progression of non-target lesions overall.

Overall response rate (ORR) is the Percentage of patients with a best overall response of complete response (CR) or partial response (PR) by month 6. ORR was assessed according to RECIST 1.1 criteria. Partial response (PR) required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as reference the baseline sum of the longest diameters. Complete response (CR) required a disappearance of all target and non-target lesions.

Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient did not have an event, progression-free survival was censored at the date of last adequate tumor assessment

Overall survival (OS) was defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival will be censored at the date of last contact.

The duration of overall response (DOR) was defined as the time from the first occurrence of a confirmed Complete Response (CR) or Partial Response (PR) (as per investigator assessment according to RECIST 1.1) until the date of the first documented disease progression or death due to underlying cancer. If a patient did not have an event or received any further anticancer therapy, duration of overall response was censored at the date of last adequate tumor assessment. Duration of response was displayed only for patients whose best overall response was CR or PR. As none of the patients showed any response (CR or PR), DOR could not be calculated

Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.

1st Line SUN

Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.

1st Line PAZ

Everolimus - All Patients that failed 1st line SUN and 1st Line PAZ and was on Everolimus 10mg orally once daily

Everolimus All Patients

Total

Age, Continuous

Sex: Female, Male

Demographic and other baseline data (including disease characteristics) were summarized descriptively for all patients for the FAS. The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.

Study Director

Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus.

Percentage of Progression-free Patients by Month 6

Percentage of Patients With Overall Response Rate (ORR) Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy at Month 6

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

Overall Survival (OS) of Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months

Duration of response was displayed only for patients whose best overall response was CR or PR. As none of the patients showed any response (CR or PR), DOR could not be calculated

Spots Global Cancer Trial Database for Safety and Efficacy of Everolimus in Metastatic Renal Cell Carcinoma After Failure of First Line Therapy With Sunitinib or Pazopanib

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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