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An Open-label, Multi-center Phase 2 Study to Evaluate Everolimus as Monotherapy Treatment for Patients With Metastatic Recurrent and/or Unresectable Renal Cell Carcinoma (EVERMORE)

Phase 4
18 Years
Open (Enrolling)
Renal Cell Carcinoma

Thank you

Trial Information

An Open-label, Multi-center Phase 2 Study to Evaluate Everolimus as Monotherapy Treatment for Patients With Metastatic Recurrent and/or Unresectable Renal Cell Carcinoma (EVERMORE)

Inclusion Criteria:

Patients may be entered in the study only if they meet all of the
following criteria:

- Age ≥18 years old;

- Patients with advanced renal cell carcinoma with confirmed clear or non-clear cell
histology, with or without nephrectomy, and with any MSKCC prognosis;

- Prior cytokine therapy is permitted;

- Patients with at least one measurable lesion at baseline as per the Response
Evaluation Criteria in Solid Tumors (RECIST) criteria. If skin lesions are reported
as target lesions, they must be documented (at baseline and at every physical exam)
using color photography and a measuring device (such as a caliper) in clear focus to
allow the size of the lesion(s) to be determined from the photograph;

- Life expectancy ≥3 months. Life expectancy should be judged in relation to other
determining patient eligibility factors such as laboratory results, Karnofsky
Performance Status, etc.;

- Patients with a Karnofsky Performance Status ≥70%;

- Adequate bone marrow function as shown by: absolute neutrophil count (ANC) ≥1.5 x
109/L, platelets ≥100 x 109/L, hemoglobin (Hb) >9 g/dL;

- Adequate liver function: serum bilirubin ≤1.5 x upper limit of normal (ULN), alanine
transaminase (ALT), and aspartate transaminase (AST) ≤2.5 x ULN;

- Adequate renal function: serum creatinine ≤1.5 x ULN;

- Females of childbearing potential must have had a negative serum or urine pregnancy
test 7 days prior to the administration of the study treatment start;

- Patients who give a written informed consent obtained according to local guidelines.

Exclusion Criteria:Patients may not be entered into the study if they meet any of the
following criteria:

- Patients within 2 weeks post-minor surgery (e.g., herniorrhaphy), 4 weeks post-major
surgery (e.g., intra-thoracic, intra-abdominal, or intra-pelvic) to avoid wound
healing complications. Percutaneous biopsies require no waiting time prior to study

- Patients with a recent history of hemoptysis, ≥0.5 teaspoon of red blood;

- Patients who have received prior systemic treatment for their metastatic RCC other
than with cytokine therapy;

- Patients who received prior therapy with a VEGF pathway inhibitor, such as sunitinib,
sorafenib, and bevacizumab;

- Patients who have previously received mTOR inhibitors (sirolimus, temsirolimus,
everolimus, deferolimus);

- History or clinical evidence of central nervous system (CNS) metastases. Note:
Subjects who have previously-treated CNS metastases (surgery ± radiotherapy,
radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible:

Are asymptomatic; Have had no evidence of active CNS metastases for ≥6 months prior to
enrollment and; Have no requirement for steroids or enzyme-inducing anticonvulsants

• Clinically significant gastrointestinal abnormalities including, but not limited to:
Malabsorption syndrome; Major resection of the stomach or small bowel that could affect
the absorption of study drug; Active peptic ulcer disease; Inflammatory bowel disease;
Ulcerative colitis, or other gastrointestinal conditions with increased risk of
perforation; History of abdominal fistula, gastrointestinal perforation, or intra
abdominal abscess within 28 days prior to beginning of study treatment;

- Patients receiving chronic systemic treatment with corticosteroids (dose of ≥10
mg/day methylprednisone equivalent) or another immune-suppressive agent. Inhaled and
topical steroids are acceptable, as well as opotherapy after bilateral adrenal gland

- Patients with a known history of human immunodeficiency virus seropositivity;

- Patients with autoimmune hepatitis;

- Patients with an active, bleeding diathesis. Patients may use coumadin or heparin

- Patients who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study;

- Patients who have a history of another primary malignancy ≤3 years, with the
exception of non-melanoma skin cancer and carcinoma in situ of uterine;

- Female patients who are pregnant or breastfeeding, or adults of reproductive
potential who are not using effective birth control methods. If barrier
contraceptives are being used, these must be continued throughout the study by both
sexes. Oral contraceptives are not acceptable;

- Patients who are using other investigational agents or who had received
investigational drugs ≤4 weeks prior to study treatment start; Patients unwilling or
unable to comply with the protocol.

Other protocol-defined inclusion/exclusion may apply

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the PFS rate over.

Outcome Time Frame:

December 2013

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

January 2014

Related Keywords:

  • Renal Cell Carcinoma
  • RCC,
  • mTOR pathway,
  • angiogenesis,
  • PFS,
  • partial response [PR] + complete response [CR])
  • metastatic recurrent renal cell carcinoma
  • metastatic unresectable renal cell carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell