A study in patients with unresectable or metastatic pancreatic, high grade serous ovarian or colorectal cancer using the drug plerixafor, with the goal of finding out the correct dose of the study drug to give, and, to find out if the study drug causes the same changes in participants that has been seen in laboratory experiments.
- Conditions
- Pancreatic adenocarcinomaHigh grade serous ovarian adenocarcinomaColorectal adenocarcinomaMedDRA version: 21.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-000117-31-GB
- Lead Sponsor
- Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 26
Patients are eligible for inclusion in the study if they meet all of the following criteria:
•Aged 16 years or over.
•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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13
Patients are to be excluded from the study if they meet any of the following criteria:
•Inadequate haematological function defined by:
oAbsolute neutrophil count (ANC) <1.5 x 109/L
oAbsolute lymphocyte count < normal level for institution
oHaemoglobin <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)
oPlatelets <100 x 109/L
oClotting; INR >1.3
•Inadequate renal function defined by calculated creatinine clearance by Cockcroft-Gault of <50 ml/min.
•Inadequate hepatic function defined by:
oAspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN) or >5 x in the presence of liver metastases
oTotal 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 judgement of the Investigator would place the patient at undue risk or interfere with the study.
•Cardiac co-morbidity:
oPast history of significant rhythm disturbance (e.g. SVT, AF or ventricular irregularities)
oRequirement for pacemaker
oMyocardial infarction in the previous 6 months
oKnown 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.
•Participation in any other interventional clinical trial
•Women, who are pregnant, plan to become pregnant or are lactating (during the study or for up to 3 months after the last dose)
•Men who plan to father a child within 3 months after the last dose
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method