Phase 2 Open Label MGCD265 in patients with NSCLC
Research type
Research Study
Full title
Phase 2, Parallel-Arm Study of MGCD265 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Activating Genetic Alterations in Mesenchymal-Epithelial Transition Factor
IRAS ID
183134
Contact name
Martin Forster
Contact email
Sponsor organisation
Mirati Therapeutics, Inc.
Eudract number
2015-002070-21
Duration of Study in the UK
1 years, 2 months, 8 days
Research summary
Lung cancer remains the leading cause of cancer-related death in the United States; a type of cancer called non-small cell lung cancer (NSCLC) accounts for approximately 83% of cases. The aim of this phase 2 study is to determine if the medicine MGCD265 is effective in treating locally advanced or metastatic (spread to other parts of the body) NSCLC in participants whose cancer has particular changes in its DNA (gene mutations or amplifications).
MGCD265 is an investigational medication that belongs to a class of drugs known as tyrosine kinase inhibitors, which block proteins that are thought to cause cancer cells to grow and spread. Participants are required to have a pre-screen that involves testing samples of previously taken tumour biopsy or, if not available, a new biopsy will be performed. These samples will be tested for the presence of particular genetic changes that may make the tumour sensitive to treatment with MGCD265.Participants will be assigned to one of four groups depending on the particular genetic changes in their tumour cells. The study will expand and enrol more participants into particular groups depending on how well participants in those groups respond, i.e. how much their tumours shrink in response to treatment. The study will aim to enrol up to 320 participants at approximately 100 sites but this may increase to 150 sites.
The main purpose of this study is to test whether participants benefit from treatment with MGCD265. Other objectives include assessing side effects of MGCD265, whether different methods for evaluating tumour genes identify the same changes, and how much and how quickly MGCD265 is absorbed and cleared from the blood stream.MGCD265 will be administered as an oral tablet twice daily in 21-day cycles. Treatment will continue until participants withdraw, experience disease progression, unacceptable adverse events, or death.
REC name
London - Westminster Research Ethics Committee
REC reference
15/LO/1936
Date of REC Opinion
30 Nov 2015
REC opinion
Favourable Opinion