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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Renal Cell Carcinoma

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Trial Information

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


Inclusion Criteria:



- Advanced renal cell carcinoma of a histological or cytological confirmation of clear
cell (or with a component of clear cell) renal carcinoma that have previously
progressed on or were intolerant to first-line therapy with sunitinib, sorafenib,
pazopanib, axitinib, bevacizumab, or cytokine therapy.

- Prior nephrectomy (partial or total)

- Patients with at least one measurable lesion at baseline as per the RECIST 1.0
criteria

- Karnofsky Performance Status ≥ 70%

Exclusion Criteria:

- Patients who have received more than one prior treatment regimen for metastatic
renal-cell carcinoma

- Patients who have received adjuvant therapy for RCC

- Patients who have previously received systemic mTOR inhibitors (eg, sirolimus,
temsirolimus, everolimus)

- Patients with brain metastases

- Patients within 4 weeks post-major surgery, open biopsy, or significant traumatic
injury to avoid wound healing complications.

- Patients who had radiation therapy within 4 weeks prior to start of study treatment
(palliative radiotherapy to bone lesions allowed up to 2 weeks prior to study
treatment start).

- Concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled
diabetes, active or uncontrolled infection) that could cause unacceptable safety
risks or compromise compliance with the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival in patients who receive everolimus as second-line treatment for metastatic renal cell carcinoma

Outcome Description:

To assess the duration of progression-free survival (PFS) during second-line treatment, 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 PFS will be based on the local radiological data according to the RECIST 1.0 Criteria.

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001L2404

NCT ID:

NCT01491672

Start Date:

November 2011

Completion Date:

November 2013

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • Metastatic Renal Cell Carcinoma
  • Second Line
  • Everolimus
  • RAD001
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021