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To Assess the Safety of Continuous IV Administration of Plerixafor in Patients With Advanced Pancreatic, Ovarian and Colorectal Cancers (CAM-PLEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02179970
Recruitment Status : Completed
First Posted : July 2, 2014
Last Update Posted : July 23, 2019
Sponsor:
Collaborators:
Sanofi
Stand Up To Cancer
CRUK Cambridge Institute
Lustgarten Foundation
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Metastatic Ovarian Serous Adenocarcinoma Colorectal Cancer Metastatic Drug: Plerixafor Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Plerixafor (Mozobil)
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.
Drug: Plerixafor
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




Primary Outcome Measures :
  1. Safety of Investigational Medicinal Product (IMP) [ Time Frame: 24 months ]
    Determining the causality of adverse events (AEs) and serious adverse events (SAEs)


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Disease status [ Time Frame: 24 months ]
    Anticancer impact following treatment with plerixafor.

  2. Disease status [ Time Frame: 24 months ]
    Metabolic tumour changes using FDG-PET.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Locations
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United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
Sponsors and Collaborators
CCTU- Cancer Theme
Sanofi
Stand Up To Cancer
CRUK Cambridge Institute
Lustgarten Foundation
National Institute for Health Research, United Kingdom
Investigators
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Study Director: Professor Duncan Jodrell CRUK Cambridge Institute and the University of Cambridge

Additional Information:
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Responsible Party: CCTU- Cancer Theme, Professor Duncan Jodrell, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02179970    
Other Study ID Numbers: CAM-PLEX
2014-000117-31 ( EudraCT Number )
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Keywords provided by CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust:
Advanced pancreatic cancer
Advanced ovarian cancer
Advanced colorectal cancer
Metastatic pancreatic cancer
Metastatic ovarian cancer
Metastatic colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenocarcinoma
Cystadenocarcinoma, Serous
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Plerixafor octahydrochloride
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents