Contact information
Type
Scientific
Primary contact
Dr Marcus Wiedmann
ORCID ID
Contact details
Philipp-Rosenthalstr. 27
Leipzig
04103
Germany
+49 (0)34 1971 2230
wiedm@medizin.uni-leipzig.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CSTI571BDE55
Study information
Scientific title
Acronym
GlivecGG
Study hypothesis
The aim is to assess the pharmacokinetics and efficacy of imatinib in patients with bile duct cancer and to test Positron Emission Tomography (PET) as a diagnostic tool.
Ethics approval
Approved by the Local Ethics Committee of Leipzig University on 28 November 2005.
Study design
Non-randomised open label multicentre study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Non-resectable bile duct cancer
Intervention
1. Continuous second line chemotherapy with imatinib - assessment of response by tumor marker and imaging during follow-up
2. Generation of pharmacokinetic data during the first two days of drug administration and during the following weeks
3. Assessment of the efficacy of PET for evaluation of early treatment response
Added 01/09/09: trial was stopped prematurely due to a lack of a sufficient number of patients (9 in three and a half years).
Intervention type
Drug
Phase
Not Specified
Drug names
Imitanib (Glivec)
Primary outcome measures
1. Response rate
2. Median duration of objective remission
Secondary outcome measures
1. Time to progression
2. Median survival
3. Tumor response after one week or three months by 18-fluorodeoxyglucose-Positron Emission Tomography (18 FDG-PET)
4. Toxicity
5. Pharmacokinetics
Overall trial start date
01/03/2006
Overall trial end date
28/02/2010
Reason abandoned
Participant recruitment issue
Eligibility
Participant inclusion criteria
1. Two-dimensional detectable tumors or metastasis
2. Aged between 18 and 75 years
3. General condition - World Health Organisation (WHO) <2
4. Live expectancy of at least three months
5. Informed consent
6. Bilirubin not to be elevated more than upper normal value (1.5 times in the presence of liver metastasis) and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 1.5 times (2.5 times in the presence of liver metastasis) of the upper normal value
7. Creatinine <133 µmol/l (<1.5 mg/l), creatinine clearance >60 ml/min
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 - recruitment closed on 31/08/09 (9 recruited).
Participant exclusion criteria
1. Pregnant and lactating women, fertile men and women without adequate contraception
2. Patients that have not received primary chemotherapy
3. Pre-operated tumor recurrence
4. Tumor extent >50% of the liver or >25% of the lung, abdominal mass >10 cm, Central Nervous System (CNS) metastasis
5. Ileus
6. Non-measurable tumor
7. Known intolerance to imatinib and its preservatives
8. Second malignancy
9. Second unstable disease
10. Co-medication with non-approved drugs
11. Any other anti-cancer treatment
12. Co-medication with paracetamol
Recruitment start date
01/03/2006
Recruitment end date
28/02/2010
Locations
Countries of recruitment
Germany
Trial participating centre
Philipp-Rosenthalstr. 27
Leipzig
04103
Germany
Sponsor information
Organisation
University of Leipzig (Germany)
Sponsor details
Ritterstr. 26
Leipzig
04109
Germany
wiedm@medizin.uni-leipzig.de
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Novartis Pharma GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Business Unit Oncology (Geschäftseinheit Onkologie) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary