Pancreatic Adenocarcinoma MetastaticPhase 1CAM-PLEXNCT02179970
To Assess the Safety of Continuous IV Administration of Plerixafor in Patients With Advanced Pancreatic, Ovarian and Colorectal Cancers
A Phase 1 study testing Plerixafor in people with Pancreatic Adenocarcinoma Metastatic and Ovarian Serous Adenocarcinoma, run by CCTU- Cancer Theme at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma Metastatic, Ovarian Serous Adenocarcinoma, Colorectal Cancer Metastatic
- What is being tested?
- Plerixafor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to 14 Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Pancreatic Adenocarcinoma Metastatic, Ovarian Serous Adenocarcinoma, Colorectal Cancer Metastatic
- Being tested
- Plerixafor
- Keywords
- Advanced pancreatic cancer, Advanced ovarian cancer, Advanced colorectal cancer, Metastatic pancreatic cancer, Metastatic ovarian cancer, Metastatic colorectal cancer
- Medical subject headings
- Pancreatic Neoplasms, Ovarian Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlerixaforDrug
Also called Mozobil
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.
| Study group | Role | What they receive |
|---|---|---|
| Plerixafor (Mozobil) | Other | 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. Receives: Drug: Plerixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Investigational Medicinal Product (IMP)
Determining the causality of adverse events (AEs) and serious adverse events (SAEs)
Measured: 24 months
Secondary outcomes (1)
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJun 2015
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Adenocarcinoma MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- CCTU- Cancer Theme
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Stand Up To Cancer, CRUK Cambridge Institute, Lustgarten Foundation, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor-investigator, CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Professor Duncan Jodrell, Study director, CRUK Cambridge Institute and the University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179970
- Sponsor's protocol ID
- CAM-PLEX
- Other IDs
- 2014-000117-31, 2014
- Acronym
- CAM-PLEX
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2014
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02179970
- Acronym / sponsor ID
- CAM-PLEX / CAM-PLEX
- Conditions
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- CCTU- Cancer ThemeUniversity, hospital or other
- Collaborators
- Sanofi, Stand Up To Cancer, CRUK Cambridge Institute, Lustgarten Foundation, National Institute for Health Research, United Kingdom
- Study start
- Jun 2015 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plerixafor (Mozobil) | Other | Drug: PlerixaforPlerixafor (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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlerixaforAlso: MozobilA 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. | Drug | Plerixafor (Mozobil) |
Primary outcome
Safety of Investigational Medicinal Product (IMP)
Time frame: 24 months
Determining the causality of adverse events (AEs) and serious adverse events (SAEs)
1 secondary outcome
Pharmacokinetics of the Investigational Medicinal Product (IMP) within the body.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Cambridge Pancreatic Centre, University of CambridgeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Duncan Jodrell study director
CRUK Cambridge Institute and the University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Plerixafor in people with Pancreatic Adenocarcinoma Metastatic and Ovarian Serous Adenocarcinoma, run by CCTU- Cancer Theme at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Investigational Medicinal Product (IMP) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.