MS201923-0007 Rollover Study Continued Treatment with M6620
Research type
Research Study
Full title
A Rollover Study to Provide Continued Treatment with M6620. This is a roll over study to NRES Ref: 14/LO/0372 (An Open-Label Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of VX-970 as a Single Agent and in Combination With Carboplatin in Subjects With Advanced Solid Tumors. Protocol VX13-970-002
IRAS ID
233060
Contact name
Juanita Lopez
Contact email
Sponsor organisation
Merck KGaA
Eudract number
2017-002354-37
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Chemotherapy and radiation that induce DNA damage to cancer cells are an effective and common treatment for people with many types of solid tumours. However, many cancers, despite displaying initial response to these agents will ultimately progress. One mechanism that has been proposed to protect cancer cells from DNA damage is the DNA damage response (DDR) pathway that is regulated by certain enzymes called kinases. Enzymes are protein molecules in cells which work as catalysts (meaning that they speed up chemical reactions).
In many cancer cells, these enzymes play a crucial role in protecting cancer cells from DNA damage and subsequently cell death. Therefore inhibiting these enzymes should enhance the effect of DNA damaging chemotherapy on cancer cells.
Vertex Inc (Boston, MA, USA) developed a selective inhibitor of ataxia telangiectasia and Rad3-related (ATR) protein (Vertex code VX-970). Merck acquired the rights for this compound and will continue the development. The Vertex study drug, VX-970, will be referred to as M6620 when used in this and future clinical studies.
This is a phase 1 roll over study using M6620 (previously VX-970).
It will look at the safety of patients who are on long term treatment with M6620.
This will be a multicohort Safety Follow Up study. Patients will be transitioned from ongoing study VX13-970-002. The Patients will continue treatment on the same dose and schedule as the original study after being transitioned.In total, at the time of writing the protocol there were 3 potential patients eligible to roll over. One patient in Part A (maximum tolerated dose of M6620) and two patients from part B (Part B will identify the MTD of M6620 when used in combination with carboplatin).
REC name
London - Surrey Borders Research Ethics Committee
REC reference
17/LO/1732
Date of REC Opinion
24 Oct 2017
REC opinion
Favourable Opinion