: First in Human Study of VX-970/M6620 in Advanced Solid Tumors MS201923-0001
Research type
Research Study
Full title
An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of VX-970/M6620 in Combination With Cytotoxic Chemotherapy in Subjects With Advanced Solid Tumors
IRAS ID
112876
Contact name
Elizabeth Ruth Plummer
Contact email
Sponsor organisation
Vertex Pharmaceuticals Incorporated
Eudract number
2012-003126-25
ISRCTN Number
N/A
Research summary
This is the first time in which VX-970 will be given to people. Because of the way VX-970 works, it requires the use of another drug to treat cancer. Therefore subjects in this Study will also receive either gemcitabine or cisplatin and etoposide, chemotherapeutic agents approved for treatment of several solid tumours. The combination of VX-970 with cisplatin or with gemcitabine has been shown in animal studies to increase the activity of the chemotherapy against tumours. VX-970 may also increase the activity of etoposide against tumours. Approximately 60-66 subjects with advanced stage solid tumours will be enrolled in the Study at 4 sites in the United Kingdom. This Study consists of 3 parts, Parts A, B and C. Patients will only participate in either Parts A, B or C. Part A. There will be approximately 24 subjects enrolled in Part A. The total time you will be in this Study is approximately 26 weeks, including a 28-day screening window and 8 week follow up period. Part B. There will be approximately 18 subjects enrolled in Part B. The total time you will be in this Study is approximately 28 weeks, including a 28-day screening window and 8 week follow up period. A lead-in period may be required, which would extend the total time in this Study to approximately 30 weeks. Part C. There will be up to 24 subjects enrolled in Part C. The total time you will be in this Study is approximately 36 weeks, including a 28-day screening window and 8 week follow up period.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
12/NE/0323
Date of REC Opinion
27 Sep 2012
REC opinion
Favourable Opinion