E7080 alone or with Everolimus in patients with renal cell carcinoma
Research type
Research Study
Full title
An Open-Label, Multicenter Phase 1b/2 Study of E7080 Alone, and in Combination with Everolimus in Subjects with Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment
IRAS ID
71002
Sponsor organisation
Eisai Ltd
Eudract number
2010-019484-10
Clinicaltrials.gov Identifier
Research summary
Kidney cancer represents approximately 3% of cancers worldwide. Renal cell carcinoma (RCC) is the most common form. RCC is generally resistant to chemotherapy, radiotherapy and hormone therapy. Immunotherapy benefits a small fraction of patients but is associated with severe toxicity. Targeted agents have been developed which inhibit the processes leading to cancer growth. These agents have improved the length of time before disease progression but complete and ongoing responses are not achieved in the majority of patients. E7080 is a drug that is in development and is a targeted agent which inhibits a pathway of cancer growth with high specificity. It is thought that this high specificity may mean that E7080 in combination with other inhibitors will be well tolerated. This study looks at the combination of E7080 with everolimus. These two drugs are thought to inhibit two different possible ways in which a tumour cell can grow and spread. This study will be conducted in 2 phases; Study participants will take part in either Phase 1b or Phase 2:Phase 1b will determine the maximum tolerated doses of E7080 and everolimus given in combination. Phase 2 will compare the safety and efficacy of (1) E7080 and everolimus at the maximum tolerated dose; (2) E7080 daily and (3) everolimus daily. Following the screening and baseline period, eligible patients will enter the treatment period and receive E7080 and/or everolimus once a day in 28-day cycles. They will continue until disease progression, unacceptable toxicity, withdrawal of consent or discontinuation of E7080 development. After Cycle 1, patients will attend study visits once or twice every cycle. Procedures to be performed at these visits include vital signs, physical examinations, ECGs, MUGA scans, CT or MRI scans, blood and urine samples.This study is sponsored by Eisai Ltd.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
11/LO/0619
Date of REC Opinion
18 Jul 2011
REC opinion
Further Information Favourable Opinion