Description:

ODM derived from http://clinicaltrials.gov/show/NCT00688753

Link:

http://clinicaltrials.gov/show/NCT00688753

Keywords:
Versions (3) ▾
  1. 12/9/13
  2. 4/16/14
  3. 4/16/14
Uploaded on:

April 16, 2014

DOI:
No DOI assigned. To request one pleaselog in.
License:
Creative Commons BY-NC 3.0 Legacy
Model comments:

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for:

Item comments for:

In order to download data models you must be logged in. Please log in or register for free.

Eligibility DRKS00004096 NCT00688753 Carcinoma

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Age at least 18 Years
Patients with metastatic papillary renal cell carcinoma, type I or II
Patients with at least one measurable lesion
ECOG performance status finding <= 1
Adequate bone marrow function
Adequate liver function
Adequate renal function
Adequate lipid profile
Exclusion Criteria
Patients who had radiation therapy within 28 days prior to start of study.
Patients who have received prior systemic treatment for their metastatic RCC.
Patients who received prior therapy with VEGF pathway inhibitor.
Patients who have previously received systemic mTOR inhibitors.
Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients.
Patients with uncontrolled central nervous system (CNS) metastases.
Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
Patients with a known history of HIV seropositivity.
Autoimmune Hepatitis
Patients with an active, bleeding diathesis.
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 and off treatment ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix.
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
Patients unwilling to or unable to comply with the protocol.