CAM-PLEX follow-up
Research type
Research Study
Full title
Observational study of future outcomes of patients consented to CAM-PLEX
IRAS ID
166177
Contact name
Duncan Jodrell
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Duration of Study in the UK
4 years, 1 months, 1 days
Research summary
In the absence of resectability, pancreatic ductal adenocarcinoma (PDAC) is almost uniformly lethal; therefore there is a great need to identify novel therapeutic approaches.
The Cambridge University Hospitals NHS Foundation Trust and University of Cambridge investigator-initiated CAM-PLEX interventional trial was set up as a prospective, non-randomised, open label Phase I, standard 3+3 dose escalation trial with treatment expansion phase, using plerixafor. The dose escalation phase includes up to 18 patients with inoperable advanced or metastatic pancreatic, high-grade serous ovarian or colorectal adenocarcinoma, while the expansion phase will only include 10 patients with locally advanced or metastatic pancreatic adenocarcinoma.
The aim of the CAM-PLEX study was to evaluate the safety of plerixafor infusion in this patient population and to identify the proof of mechanism by radiological, histological and blood biomarker assessments. Furthermore, patients will have received up to two continuous 7 day infusions of plerixafor, and will have been followed-up on Day 56 after their initial infusion. However, immunotherapies may have patterns of responses that differ from classical chemotherapy treatments, most notably delayed responses and clinical benefit. Therefore, assessment of the future outcomes of CAM-PLEX patients may add significant knowledge to this potential immunotherapy strategy.
This follow-up study is a single-centre survival follow-up study of patients who have consented to the CAM-PLEX study. In order to assess the effect of plerixafor treatment given as part of the CAM-PLEX study, we aim to collect data on the participant’s survival status and any subsequent treatments.
All participants who gave written informed consent to the CAM-PLEX interventional study and received part or the entire plerixafor infusion will be approached to participate in this follow-up study. Data will be collected approximately every 3 months from the end of study visit, and follow-up will continue until the participant’s death or for 2 years.
We will recruit up to a maximum of 35 participants.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
15/EM/0383
Date of REC Opinion
12 Aug 2015
REC opinion
Favourable Opinion