Back to resultsTo Assess the Safety of Continuous IV Administration of Plerixafor in Patients With Advanced Pancreatic, Ovarian and Colorectal Cancers (CAM-PLEX)
Primary Purpose
Pancreatic Adenocarcinoma Metastatic, Ovarian Serous Adenocarcinoma, Colorectal Cancer Metastatic
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Plerixafor
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Adenocarcinoma Metastatic focused on measuring Advanced pancreatic cancer, Advanced ovarian cancer, Advanced colorectal cancer, Metastatic pancreatic cancer, Metastatic ovarian cancer, Metastatic colorectal cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Myocardial infarction in the previous 6 months.
- Known medical history of proven postural hypotension.
- Active infection.
- Patients with known allergy to plerixafor or its excipients.
- Patients known to have hepatitis B, hepatitis C or HIV infection.
- Women, who are pregnant, plan to become pregnant or are lactating (during the study or for up to 3 months after the last dose)
Sites / Locations
- Addenbrookes Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Plerixafor (Mozobil)
Arm Description
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.
Outcomes
Primary Outcome Measures
Safety of Investigational Medicinal Product (IMP)
Determining the causality of adverse events (AEs) and serious adverse events (SAEs)
Secondary Outcome Measures
Pharmacokinetics of the Investigational Medicinal Product (IMP) within the body.
Determining the absorption, distribution, metabolism, and excretion rates of the IMP through concentration rates in plasma samples.
Full Information
NCT ID
NCT02179970
First Posted
July 1, 2014
Last Updated
July 19, 2019
Sponsor
CCTU- Cancer Theme
Collaborators
Sanofi, Stand Up To Cancer, CRUK Cambridge Institute, Lustgarten Foundation, National Institute for Health Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT02179970
Brief Title
To Assess the Safety of Continuous IV Administration of Plerixafor in Patients With Advanced Pancreatic, Ovarian and Colorectal Cancers
Acronym
CAM-PLEX
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
December 14, 2018 (Actual)
Study Completion Date
December 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CCTU- Cancer Theme
Collaborators
Sanofi, Stand Up To Cancer, CRUK Cambridge Institute, Lustgarten Foundation, National Institute for Health Research, United Kingdom
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma Metastatic, Ovarian Serous Adenocarcinoma, Colorectal Cancer Metastatic
Keywords
Advanced pancreatic cancer, Advanced ovarian cancer, Advanced colorectal cancer, Metastatic pancreatic cancer, Metastatic ovarian cancer, Metastatic colorectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plerixafor (Mozobil)
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Plerixafor
Other Intervention Name(s)
Mozobil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety of Investigational Medicinal Product (IMP)
Description
Determining the causality of adverse events (AEs) and serious adverse events (SAEs)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Pharmacokinetics of the Investigational Medicinal Product (IMP) within the body.
Description
Determining the absorption, distribution, metabolism, and excretion rates of the IMP through concentration rates in plasma samples.
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Disease status
Description
Anticancer impact following treatment with plerixafor.
Time Frame
24 months
Title
Disease status
Description
Metabolic tumour changes using FDG-PET.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Myocardial infarction in the previous 6 months.
Known medical history of proven postural hypotension.
Active infection.
Patients with known allergy to plerixafor or its excipients.
Patients known to have hepatitis B, hepatitis C or HIV infection.
Women, who are pregnant, plan to become pregnant or are lactating (during the study or for up to 3 months after the last dose)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Duncan Jodrell
Organizational Affiliation
CRUK Cambridge Institute and the University of Cambridge
Official's Role
Study Director
Facility Information:
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.cambridge-pcc.org/
Description
Cambridge Pancreatic Centre, University of Cambridge
Learn more about this trial
To Assess the Safety of Continuous IV Administration of Plerixafor in Patients With Advanced Pancreatic, Ovarian and Colorectal Cancers
We'll reach out to this number within 24 hrs