Condition category
Cancer
Date applied
02/02/2006
Date assigned
27/02/2006
Last edited
01/09/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes