To Assess the Safety of Continuous IV Administration of Plerixafor in Patients With Advanced Pancreatic, Ovarian and Colorectal Cancers (CAM-PLEX)
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|ClinicalTrials.gov Identifier: NCT02179970|
Recruitment Status : Completed
First Posted : July 2, 2014
Last Update Posted : July 23, 2019
Pancreatic, ovarian and colorectal cancers are difficult to treat using chemotherapy and immune therapies.Currently most patients are offered treatment with a standard chemotherapy drug depending on their cancer type. Recently, laboratory studies have shown that a drug called plerixafor may help the body to overcome resistance to immune therapy.
The purpose of this study is to find out if the study drug has the same effect on patients with advanced pancreatic, ovarian or colorectal cancer, as we have seen in our laboratory experiments, and find out the right dose of the study drug to give. This is a 'dose escalation study'. Patients will be recruited slowly and the study team will closely monitor the effect the drug has, until they find the best dose to give. As part of this study, blood and tumour samples will be collected and analysed in our laboratories and the patients cancer will be monitored using two imaging techniques, CT and FDG-PET scans.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma Metastatic Ovarian Serous Adenocarcinoma Colorectal Cancer Metastatic||Drug: Plerixafor||Phase 1|
This is a prospective, non-randomised, open label, Phase I, dose escalation study of plerixafor (MozobilTM) in patients with histological documentation of advanced pancreatic, high grade serous ovarian or colorectal adenocarcinoma. We will investigate the feasibility of administering plerixafor in terms of safety, and will try to identify the proof of mechanism in patients.
This study is required to establish whether relevant plasma concentrations of plerixafor can be achieved safely in patients with advanced pancreatic, high grade serous ovarian and colorectal cancer.
Plerixafor (Mozobil) will be administered as a continuous 7 day intravenous infusion, starting at a dose of 20 ug/kg/hr, and subsequent dose levels of 40, 80 and 120 ug/kg/hr (as an inpatient for at least the initial 48 hours). 3 patients will be entered sequentially (at least 1 week apart), using a standard 3+3, Phase I trial design. Up to 28 patients will be recruited.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||To Assess the Safety of Continuous IV Administration of the CXCR4 Antagonist, Plerixafor (Mozobil), and Assess Its Impact on the Immune Microenvironment in Patients With Advanced Pancreatic, High Grade Serous Ovarian and Colorectal Adenocarcinomas.|
|Actual Study Start Date :||June 2015|
|Actual Primary Completion Date :||December 14, 2018|
|Actual Study Completion Date :||December 14, 2018|
Plerixafor (Mozobil), continuous 7 day IV infusion. Starting at a dose of 20 ug/kg/hr, and subsequent dose levels of 40, 80 and 120 ug/kg/hr.
A continuous 7 day intravenous infusion, starting at a dose of 20 ug/kg/hr, and subsequent dose levels of 40, 80 and 120 ug/kg/hr.
Other Name: Mozobil
- Safety of Investigational Medicinal Product (IMP) [ Time Frame: 24 months ]Determining the causality of adverse events (AEs) and serious adverse events (SAEs)
- Pharmacokinetics of the Investigational Medicinal Product (IMP) within the body. [ Time Frame: 24 months ]Determining the absorption, distribution, metabolism, and excretion rates of the IMP through concentration rates in plasma samples.
- Disease status [ Time Frame: 24 months ]Anticancer impact following treatment with plerixafor.
- Disease status [ Time Frame: 24 months ]Metabolic tumour changes using FDG-PET.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179970
|Cambridge, United Kingdom, CB2 0QQ|
|Study Director:||Professor Duncan Jodrell||CRUK Cambridge Institute and the University of Cambridge|