JVDK: Ramucirumab Combined with Other Medications in Advanced Cancers
Research type
Research Study
Full title
An Open-Label, Phase 1a/1b Study of Ramucirumab in Combination with Other Targeted Agents in Advanced Cancers
IRAS ID
206123
Contact name
Debashis Sarker
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2015-004381-28
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
A large variety of cellular processes, interactions and responses come in to play in the growth and development of all cancer types.
Vascular endothelial growth factor (VEGF) is a protein produced by cells that stimulates and encourages angiogenesis and vasculogenesis. Angiogenesis is one of the main processes involved in tumour growth. During the process of angiogenesis blood vessels form from pre-existing blood vessels. It is a fundamental step in the transition of tumours from a benign state to a malignant one. Vasculogenesis is another process that can potentially help tumours to grow.
Ramucirumab is a medication which inhibits VEGF development and therefore also the processes of angiogenesis and vasculogenesis.
Ramucirumab is already an approved treatment for use in advanced stomach cancer and is being tested in a number of other different cancers. This study will look at the use of Ramucirumab across several cancer types and in combination with other treatments in each of those cancer areas. It is hoped that the study will uncover additional types of cancer in which Ramucirumab might be an effective treatment.
The study will have several 'Arms' which will be covered in protocol addendums and each addendum will use Ramucirumab in conjunction with a different additional treatment. This first part of the study includes Arm 1, looking at Ramucirumab with Merestinib in Colorectal cancer and Arm 2, looking at Ramucirumab with Abemaciclib in Mantle Cell Lymphoma.
To be eligible for Arm 1 patients will need to be a minimum of 18 years old and have a diagnosis of Colorectal cancer. To be eligible for Arm 2 patients must be a minimum of 18 years old and have a diagnosis of Mantle Cell Lymphoma.
Study assessments will include: Physical examinations, ECGs, blood and urine tests and radiological scans.
REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/1651
Date of REC Opinion
24 Nov 2016
REC opinion
Further Information Favourable Opinion