LY2801653 and LY3009806 - Advanced or Metastatic Biliary Tract Cancer
Research type
Research Study
Full title
Randomized, Double-Blind, Phase 2 Study of Ramucirumab or Merestinib or Placebo plus Cisplatin and Gemcitabine as First-Line Treatment in Patients with Advanced or Metastatic Biliary Tract Cancer
IRAS ID
200426
Contact name
Elizabeth Balogun
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2015-004699-31
Duration of Study in the UK
2 years, 0 months, 6 days
Research summary
Biliary tract cancer (BTC) is a cancer that has spread in and around the biliary tract. The biliary tract carries the digestive juice (bile), which plays an important role in food digestion (by breaking down fat). Bile is made by the liver and stored in the gall bladder. The bile ducts connect the liver and gall bladder to the small bowel. The bile ducts and gall bladder form the biliary tract. In Great Britain about 2000 people are diagnosed each year with bile duct cancer. The JSBF Study is finding out whether Ramucirumab or Merestinib, in combination with Cisplatin and Gemcitabine, can help patients with biliary tract cancer.
Ramucirumab works to inhibit a process called angiogenesis. Angiogenesis is a process through which blood vessels form from pre-existing blood vessels. By inhibiting angiogenesis, Ramucirumab cuts off the blood supply to certain cancer cells. Ramucirumab already has approval in the UK to be used on its own, or with another medicine called Paclitaxel, to treat advanced stomach cancer (or cancer of the junction between the gullet and the stomach) in adults whose disease has worsened after treatment with medicines to treat cancer.
Merestinib is a type of biological therapy known as a cancer growth blocker, which blocks the growth factors that trigger the cancer cells to divide and grow. Merestinib works by blocking chemical messengers called tyrosine kinases, which help to send growth signals in cells. Blocking them may stop the cell growing and dividing. Merestinib acts on the tyrosine receptor known as MET; abnormal signalling pathways of MET have been found in a wide variety of cancers and are a common feature of biliary tract cancers.
To be eligible to participate in this study, patients must be 18 years old or over and have a diagnosis of biliary tract cancer, which has progressed such that it cannot be removed by surgery or has spread to other areas of the body. Patients will receive treatment of ramucirumab or merestinib or placebo, during 21 day cycles, and can continue to participate in the study for as long as the study doctor determines that the patient is benefitting from the treatment.
Study assessments will include physical examinations, ECGs, questionnaire completion, blood and urine tests and imaging scans (such as CT or MRI scans).
REC name
North West - Haydock Research Ethics Committee
REC reference
16/NW/0379
Date of REC Opinion
13 May 2016
REC opinion
Favourable Opinion