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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-21

Study Completion Date

2016-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Renal Cell Carcinoma (mRCC)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Everolimus

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once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.

Group Type EXPERIMENTAL

Everolimus (RAD001)

Intervention Type DRUG

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

Interventions

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Everolimus (RAD001)

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

Intervention Type DRUG

Other Intervention Names

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RAD001

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No