The study the safety and imaging characteristics of GE-137
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety of GE-137 in healthy volunteers and patients with high suspicion of
colorectal cancer, using standard safety measures
Secondary outcome
-To detemine the optimal dose of GE-137 and the optimal timing between GE-137
dosing and endoscopy.
-To determine if GE-137 detects areas of increase fluorescence in the colon
that correlate with pathology and c-Met expression in patients with high
suspicion of CRC
Background summary
Colorectal cancer is 1 of the major causes of cancer deaths globally. The clear
link between risk factors like age and predisposition makes Colorectal cancer
(CRC) an ideal candidate for screening. Stratification of benign v.s.
adenomatous laesion is not readily possible with routine (with light)
colonoscopy. Also, light colonoscopy is less sensitive for the detection of
flat laesions. GE Healthcare has developed a fluorescent marker ((GE-137) for
potential diagnosis for CRC.
GE-137 targets C-met, which is a marker for CRC. With GE-137 and red light
colonoscopy, early leasions may be detected.
Study objective
The study the safety and imaging characteristics of GE-137
Study design
Het study consists of two parts.
Firstly, in healthy volunteers the safety and optimal dosing of GE-137 will be
investigated. Secondly, the safety and imaging characteristics of GE-137 will
be investigated in patients with high suspicion of colorectal cancer.
The first part (in healthy volunteers) is a randomised, placebo controlled,
parallel single rising dose study (4 dose groups GE-137 from 0.02 to a maximum
of 0.36 mg/kg body weight [bw]).
The second part is an open-label study with one dose of of GE-137.
Intervention
GE-137 or placebo
Study burden and risks
At sceening clinical signifcant abnormalities might be discovered. The
endoscopy has a slight change (smaller than 1%) for a complication (bowel
perforation of bleeding of intestine).
A day before the endoscopy, the subjects need to have a bowel preparation
(drinking 2L of Movi prep (healthy volunteers and patients) and 2 tablets of
bisacodyl (patients only)).
Rondom 8 ,
5600AP eindhoven
NL
Rondom 8 ,
5600AP eindhoven
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers:
(1) The subject is >=18 and <=70 years old at screening.
(2) Female subjects need to be either surgically sterile, post menopausal or pre menopausal with a negative urine pregnancy test.
(3) The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained before any study-related procedure is performed.
(4)The subject has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening
(5)The subject*s screening ECG and clinical laboratory test results are within normal limits.
(6)The subject has negative test results for drug and alcohol screening.
(7)The subject*s body mass index is <= 30 but not <18 kg/m2.
(8)The subject has negative test results for hepatitis B, hepatitis C, and human immunodeficiency virus.;Subjects with High Suspicion of Colorectal Cancer
(1) The subject is >= 45 years old at screening.
(2) Female subjects need to be either surgically sterile, post menopausal, or pre menopausal with a negative urine pregnancy test
(3) The subject has high suspicion of CRC.
(4) The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained before any study-related procedure is performed.
(5) The subject has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening .
(6)The subject*s screening ECG and clinical laboratory tests are within normal limits.
(7)The subject*s body mass index is <=30 but not <18 kg/m2.
Exclusion criteria
Healthy Volunteers
(1) If female, the subject is lactating or pregnant.
(2) The subject has been previously included in this study.
(3) Treatment with another investigational medicinal product (IMP) within 3 months prior to screening or more than 4 times in the past year.
(4) Loss of blood outside the limits of Sanquin within 3 months prior to screening.
(5) The subject has received any prescription or non-prescription medication regularly between 14 days and 1 day prior to IMP administration. Occasional use of analgesics, such as ibuprofen and paracetamol, etc., is permitted at the discretion of the investigator. Use of hormonal contraceptives is also permitted. ;Subjects with High Suspicion of Colorectal Cancer
(1) If female, the subject is lactating or pregnant.
(2) The subject is being treated or has been treated with chemotherapy or radiation within the 3 months before enrolment.
(3) A biopsy has been obtained from the colon within the 3 weeks before enrolment.
(4) The subject has been previously included in this study.
(5) Treatment with another IMP within 3 months prior to screening or more than 4 times in the past year.
(6) Loss of blood outside the limits of Sanquin within 3 months prior to screening.
(7) The subject has had any significant change in their regular prescription or non-prescription medication between 14 days and 1 day prior to IMP administration. Occasional use of analgesics, such as ibuprofen and paracetamol, etc., is permitted at the discretion of the investigator. Use of hormonal contraceptives is also permitted.
(8) The subject has a history of alcohol and/or drug abuse within the previous 12 months, based on a review
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-019197-33-NL |
| CCMO | NL32320.058.10 |