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

Novartis

Status and phase: Completed; Phase 4

Conditions: Metastatic Renal Cell Carcinoma (mRCC)

Treatments: Drug: Everolimus (RAD001)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01514448

2011-003416-23 (EudraCT Number)

CRAD001LDE43

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Everolimus

Experimental group

Description:

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once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.

Treatment:

Drug: Everolimus (RAD001)