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Everolimus as Second-line Therapy in Metastatic Renal Cell Carcinoma (RECORD-4)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01491672
First received: December 12, 2011
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

This study will evaluate everolimus as second-line therapy in patients with metastatic renal cell carcinoma. Each patient will be enrolled in one of three cohorts based upon their first-line therapy: 1) prior cytokines, 2) prior sunitinib, or 3) prior anti-VEGF therapy other than sunitinib.


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Drug: RAD001
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression-free survival in patients who receive everolimus as second-line treatment for metastatic renal cell carcinoma [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Safety profile of everolimus for the overall study population as well as for each first-line treatment cohort. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The assessment of safety will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of pre-determined ranges.

  • Progression-free survival separately for each first-line treatment cohort [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Kaplan-Meier product-limit estimate of the PFS survival function as well as the median PFS along with it's 95% confidence interval will be displayed on the FAS separately for each first-line treatment cohort.

  • Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The time from date of enrollment to date of death due to any cause.

  • Clinical Benefit Rate (CBR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The proportion of patients with best overall response of CR or PR or stable disease based on the local radiological data according to the RECIST 1.0 Criteria.

  • Objective Response Rate (ORR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The proportion of patients with best overall response of CR or PR based on the local radiological data according to the RECIST 1.0 Criteria

  • Duration of Response (DoR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The duration of response will also be calculated for each first-line treatment cohort, and is defined as the time from the first occurrence of PR or CR (as per local radiological review) until the date of the first documented disease progression or death due to underlying cancer.


Enrollment: 135
Study Start Date: November 2011
Estimated Study Completion Date: October 2014
Arms Assigned Interventions
Experimental: Everolimus
oral
Drug: RAD001

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491672

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Argentina
Novartis Investigative Site
Rio Negro, Viedma, Argentina, 8500
Novartis Investigative Site
Tucuman, Argentina, T4000
Brazil
Novartis Investigative Site
Florianopolis, SC, Brazil, 88034-000
Novartis Investigative Site
Barretos, SP, Brazil, 14784-400
Novartis Investigative Site
São Paulo, SP, Brazil, 01509-900
Novartis Investigative Site
São Paulo, SP, Brazil, 01246-000
Bulgaria
Novartis Investigative Site
Sofia, Bulgaria, 1784
China, Beijing
Novartis Investigative Site
Beijing, Beijing, China, 100730
China, Zhejiang
Novartis Investigative Site
Hangzhou, Zhejiang, China, 310003
China
Novartis Investigative Site
Beijing, China, 100021
Novartis Investigative Site
Guangzhou, China, 510060
Novartis Investigative Site
Shanghai, China, 200032
Russian Federation
Novartis Investigative Site
Leningrad Region, Russia, Russian Federation, 188663
Novartis Investigative Site
Moscow, Russia, Russian Federation, 125284
Novartis Investigative Site
Nizhny Novgorod, Russia, Russian Federation, 603001
Novartis Investigative Site
Obninsk, Russia, Russian Federation, 249036
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01491672     History of Changes
Other Study ID Numbers: CRAD001L2404, 2010-020447-13
Study First Received: December 12, 2011
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: Associação Fundo de Incentivo à Pesquisa
Bulgaria: Ministry of Health
China: Food and Drug Administration
Denmark: Danish Medicines Agency

Keywords provided by Novartis:
Metastatic Renal Cell Carcinoma
Second Line
Everolimus
RAD001

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on September 16, 2014