Everolimus as Second-line Therapy in Metastatic Renal Cell Carcinoma

• Register: EUCTR
• Last refreshed on: 8 February 2016
• Main ID: EUCTR2010-020447-13-BG
• Date of registration: 14/06/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Everolimus as Second-line Therapy in Metastatic Renal Cell Carcinoma
• Scientific title: 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 - RECORD-4
• Date of first enrolment: 17/08/2012
• Target sample size: 201
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020447-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

Argentina, Brazil, Bulgaria, China, India, Romania, Russian Federation, United States

Contacts

• Name: Vinnette Sallo
• Affiliation: Novartis Pharmaceuticals Corporation

• Name: Vinnette Sallo
• Affiliation: Novartis Pharmaceuticals Corporation

Key inclusion & exclusion criteria

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 firstline 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%
- Age = 18 years old

Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 101

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 exclusion criteria may apply.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

Metastatic Renal Cell Carcinoma
MedDRA version: 17.0 Level: PT Classification code 10050513 Term: Metastatic renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Trade Name: Afinitor
Product Name: Everolimus
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
CAS Number: 159351-69-6
Current Sponsor code: RAD001
Other descriptive name: EVEROLIMUS
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: every 8 weeks until the occurrence of documented disease progression
per RECIST 1.0

Primary end point(s): Progression-free survival in patients who receive everolimus as secondline treatment for metastatic renal cell carcinoma

Secondary Objective: - To assess the safety profile of everolimus for the overall study
population as well as for each first-line treatment cohort
- To assess the progression-free survival (PFS) separately for each firstline treatment cohort
- To assess the overall survival (OS) for patients treated with secondline therapy with everolimus, as well as for each first-line treatment cohort
- To assess the clinical benefit rate and duration of response in patients who receive everolimus in second-line setting, as well as for each firstline treatment cohort

Main Objective: To assess the progression-free survival (PFS) in patients who receive
everolimus as second-line treatment for metastatic renal cell carcinoma

Secondary Outcome(s)

Secondary end point(s): 1- Safety profile of everolimus for the overall study population as well as
for each first-line treatment cohort.
2- Progression-free survival separately for each first-line treatment
cohort
3- Overall survival
4- Clinical benefit rate
5- Objective response rate
6- Duration of response

Timepoint(s) of evaluation of this end point: 1- Continuously
2- Every 8 weeks until the occurrence of documented disease
progression per RECIST 1.0
3- Continuously
4- Every 8 weeks until the occurrence of documented disease
progression per RECIST 1.0
5- Every 8 weeks until the occurrence of documented disease
progression per RECIST 1.0
6- Every 8 weeks until the occurrence of documented disease
progression per RECIST 1.0

Secondary ID(s)

CRAD001L2404

Source(s) of Monetary Support

Novartis Pharma Services AG