Phase I trial of E7820

• Research type

  Research Study

• Full title

  An Open-label, Dose Escalation, Pharmacodynamic, Pharmacokinetic, and Effect of Food Phase 1 Study of E7820, Administered as a Once Daily and Twice Daily Oral Dose to Determine the Maximum Tolerated Dose in Subjects with Unresectable Solid Tumors

• IRAS ID

  69254

• Contact name

  Jeff EVANS

• Sponsor organisation

  Eisai Limited

• Eudract number

  2010-023655-28

• Research summary

  RAngiogenesis is defined as the formation of new blood vessels by endothelial cells and is usually limited to wound healing, embryonic development, and the menstrual cycle in the normal physiological condition. Angiogenesis is also required for the growth and metastasis of solid tumours. Angiogenesis inhibitors act to inhibit tumour capillary vessel growth, resulting in enhanced tumour cell apoptosis and cell death. Therefore, inhibitors will exhibit excellent efficacy against advanced cancers and metastasis through non-direct action toward cancer cells, leading to a new anticancer chemotherapy. E7820, a sulfonamide derivative, is a novel angiogenesis inhibitor based on inhibition of endothelial cell proliferation and tube formation.The study is designed in 3 parts, starting with a food effect study (part A) to define the effect of food on the amount of E7820 in the bloodstream. Then, two dose-escalation studies will be run in parallel with E7820 taken either once daily or twice daily with the aim to find out the safest and most effective dose of E7820. The study will also explore the effect of E7820 on cancer itself.Patients will be screened and if eligible, will:In part A, patients have a visit at Day 1 and Day 8 with blood samples collection. 12 patients will receive the study drug with a full breakfast during one of the visit and without breakfast during the other visit. During the Extension Phase they will take two tablets before breakfast every day. After the first cycle, the patient will be seen bi-weekly.In part B and C, patients will receive E7820 either once a day or twice a day at the dose-level tested at the time they join the study. 6 additional patients will be added per part when the maximum tolerated dose is defined. An estimate of 21 patients per part will be treated.

• REC name

  Scotland A REC

• REC reference

  11/AL/0022

• Date of REC Opinion

  28 Feb 2011

• REC opinion

  Favourable Opinion