To Assess the Safety of Continuous IV Administration of Plerixafor in Patients With Advanced Pancreatic, Ovarian and Colorectal Cancers
CAM-PLEX
2 other identifiers
interventional
26
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2014
CompletedFirst Posted
Study publicly available on registry
July 2, 2014
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2018
CompletedJuly 23, 2019
July 1, 2019
3.5 years
July 1, 2014
July 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of Investigational Medicinal Product (IMP)
Determining the causality of adverse events (AEs) and serious adverse events (SAEs)
24 months
Secondary Outcomes (1)
Pharmacokinetics of the Investigational Medicinal Product (IMP) within the body.
24 months
Other Outcomes (2)
Disease status
24 months
Disease status
24 months
Study Arms (1)
Plerixafor (Mozobil)
OTHERPlerixafor (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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Aged 16 years or over at the time of signing informed consent form.
- Dose escalation phase only: Patients with inoperable, histologically proven locally advanced or metastatic pancreatic, high grade serous ovarian or colorectal adenocarcinoma, refractory to conventional chemotherapy or a patient who has declined conventional chemotherapy. OR;
- Expansion phase only: Patients with inoperable, histologically proven locally advanced or metastatic pancreatic, refractory to conventional chemotherapy or a patient who has declined conventional chemotherapy.
- Tumour lesions considered to be accessible for core biopsy and immunostaining assessment.
- ECOG performance status 0-1.
- Life expectancy of at least 12 weeks.
- All women of child-bearing potential and all sexually active male patients must agree to use effective contraception methods throughout the study and for 3 months after the final dose of study drug.
You may not qualify if:
- Inadequate haematological function defined by:
- Absolute neutrophil count (ANC) \<1.5 x 109/L
- Absolute lymphocyte count \< normal level for institution
- Haemoglobin \<9.0 g/dL (90 g/L) (may be increased to this level with transfusion as long as there is no evidence of active bleeding)
- Platelets \<100 x 109/L
- Clotting; INR \>1.3
- Inadequate renal function defined by calculated creatinine clearance by Cockcroft-Gault of \<50 ml/min.
- Inadequate hepatic function defined by:
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2.5 x upper limit of normal (ULN) or \>5 x in the presence of liver metastases
- Total bilirubin \>1.5 x ULN
- Current treatment (within 28 days of entry) with chemotherapy, steroids or other immunosuppressive drugs.
- Significant acute or chronic medical or psychiatric condition, disease or laboratory abnormality which in the judgment of the Investigator would place the patient at undue risk or interfere with the study.
- Cardiac co-morbidity:
- Past history of significant rhythm disturbance (e.g. SVT, AF or ventricular irregularities)
- Requirement for pacemaker.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CCTU- Cancer Themelead
- Sanoficollaborator
- Stand Up To Cancercollaborator
- CRUK Cambridge Institutecollaborator
- Lustgarten Foundationcollaborator
- National Institute for Health Research, United Kingdomcollaborator
Study Sites (1)
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Professor Duncan Jodrell
CRUK Cambridge Institute and the University of Cambridge
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor Duncan Jodrell
Study Record Dates
First Submitted
July 1, 2014
First Posted
July 2, 2014
Study Start
June 1, 2015
Primary Completion
December 14, 2018
Study Completion
December 14, 2018
Last Updated
July 23, 2019
Record last verified: 2019-07