YOSEMITE Ph 2 study in subjects with Pancreatic Ductal Adenocarcinoma
Research type
Research Study
Full title
YOSEMITE: A 3-Arm Phase 2 Double-Blind Randomized Study of Gemcitabine, Abraxane® Plus Placebo versus Gemcitabine, Abraxane® plus 1 or 2 Truncated Courses of Demcizumab in Subjects with 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma
IRAS ID
170613
Contact name
Debashis Sarker
Contact email
Sponsor organisation
OncoMed Pharmaceuticals, Inc.
Eudract number
2014-003355-56
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 2 days
Research summary
Pancreatic cancer is an aggressive cancer which is usually inoperable at the time of diagnosis in 80-85% of cases. Single agent chemotherapy has a partial response in 5-15% of patients. Combination therapy of gemcitabine and Abraxane has a higher response rate, however unresectable pancreatic ductal adenocarcinoma remains an incurable disease; hence the need to develop new treatments.
Current cancer therapies often produce an initial reduction in tumour size but may not have long term benefits. A possible explanation for this is the presence of a specific type of cancer cell called a stem cell. These are believed to be responsible for much of the growth and spread of the cancer and are thought to be more resistant to traditional types of therapy.
Demcizumab is a humanised monoclonal antibody developed to target cancer stem cells, and may block growth of these cells, the remaining cancer cells and prevent growth of new blood vessels that tumours need to grow and spread.
The purpose of this study is to test the efficacy and safety of Demcizumab when given in combination with Gemcitabine and Abraxane. Participants will be randomly assigned to one of 3 treatment arms and will receive Demcizumab 3.5 mg/kg or placebo by IV infusion (prior to the administration of Abraxane® and Gemcitabine) once every 2 weeks for either one or two 70 day courses. Patients will receive treatment until disease progression, and will remain in the study until this point.
Study procedures include: vital signs, physical examinations, ECG, Doppler ECHO, urine and blood samples for laboratory tests, and tumour biopsy (if no previous samples are available) and radiographic assessments to monitor the disease or side effects of the drug.
This study is being sponsored by OncoMed Pharmaceuticals. Approximately 201 participants will take part in the study, with approximately 25 to be randomised in the UK.
REC name
London - Brent Research Ethics Committee
REC reference
15/LO/0517
Date of REC Opinion
11 May 2015
REC opinion
Further Information Favourable Opinion