Phase 1 advanced cancer study of VS-5584

• Research type

  Research Study

• Full title

  A Phase I Dose Escalation Study of VS-5584, a Dual PI3K/mTOR Inhibitor, in Subjects with Advanced Non-Hematologic Malignancies or Lymphoma

• IRAS ID

  142359

• Contact name

  Udai Banerji

• Contact email

  Udai.banerji@icr.ac.uk

• Sponsor organisation

  Verastem, Inc.

• Eudract number

  2013-003923-13

• ISRCTN Number

  n/a

• Research summary

  This is a phase I study, in which adult patients with advanced forms of cancer will be given an experimental drug, VS-5584. This drug blocks the action of two substances that are part of one of the most abnormal networks in cancers that make the cancer grow, the PI3K pathway. The purpose of this study is to determine:

  - the safety and side effects of VS-5584
  - how the body handles the drug
  - what the drug does to the body and the cancer cells
  - a safe dose and schedule of VS-5584 for further testing.

  There are two parts of this study. In the first part of the study, Dose Escalation part, patients will be treated with a low dose of the study drug. VS-5584 will be administered on an intermittent dosing schedule in 21 day cycles. VS-5584 will be
  administered orally once daily on Day 1, 3, 5, 8, 10, 12, 15, 17 and
  19 of each cycle (e.g. Monday, Wednesday, and Friday). If this dose does not cause bad side effects, it will slowly be made higher as new patients take part in the study. About 42 patients are expected to be in the first part of the study. The highest dose with no serious side-effects will be selected to test in the second part of the study.

  In the second part of the study, Expansion part, up to 20 additional patients will be enrolled at the highest dose that is found to be tolerated well by patients.

  About 62 patients in total are expected to be in this study. Patients taking part in the study will attend hospital visits where they will be monitored for side effects and whether the drug is providing benefit.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  13/LO/1850

• Date of REC Opinion

  10 Jan 2014

• REC opinion

  Further Information Favourable Opinion