Palliative Chemotherapy (2nd line) with Imatinib (GlivecTM) in Patients with Bile Duct Cancer. - GlivecGG

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003166-42-DE

Enrollment

Registered

2005-09-20

Start date

2005-12-27

Completion date

Unknown

Last updated

2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with histologically proven adenocarcinoma of the gallbladder/bile duct (not papillary cancer) in an advanced stage, who have not responded to a first line chemotherapy. MedDRA version: 8.1 Level: LLT Classification code 10004585 Term: Bile duct adenocarcinoma

Interventions

Trade Name: Glivec Product Name: Imatinib mesilate Product Code: STI571 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Imatinib mesylat CAS Number: 220127-57-1 Current Sponsor code: STI5

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: There must be a two-dimensional detectable tumor or metastasis, patient`s age must be between 18 and 75 years, patient`s general condition must be WHO 60 ml/min. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnant and lactating women, fertile men and women without adequate contraception, patients without a primary chemotherapy, tumor extent >50% of the liver or >25% of the lung, abdominal mass >10cm, CNS-metastases, ileus, non-measurable tumor extent, known intolerance to imatinib and its preservatives, second malignancy, second unstable disease, comedication with non-approved drugs, any other anti-cancer treatment, comedication with paracetamol.

Design outcomes

Primary

Measure	Time frame
Main Objective: Response rate. Median duration of objective remission.;Secondary Objective: Time to progression. Median survival. Tumor response after 1 week/3months by 18FDG-PET. Toxicity. Pharmacokinetics.;Primary end point(s): Primary Study Endpoint: Response rate (patients who fulfill inclusion criteria and have chemotherapy for at least 3 months will be analyzed, if there is sufficient documentation of tumor response with at least one follow-up examination). Median duration of objective remission. Secondary Study Endpoints: Time to progression (will be calculated from the first day of treatment to the first day of tumor progression or to the begin of a new treatment) and toxicity (all patients will be analyzed starting from the first administration of the study drug; toxicity will be analyzed according to CTC-NCI criteria).	—

Measure

Time frame

Main Objective: Response rate. Median duration of objective remission.;Secondary Objective: Time to progression. Median survival. Tumor response after 1 week/3months by 18FDG-PET. Toxicity. Pharmacokinetics.;Primary end point(s): Primary Study Endpoint: Response rate (patients who fulfill inclusion criteria and have chemotherapy for at least 3 months will be analyzed, if there is sufficient documentation of tumor response with at least one follow-up examination). Median duration of objective remission. Secondary Study Endpoints: Time to progression (will be calculated from the first day of treatment to the first day of tumor progression or to the begin of a new treatment) and toxicity (all patients will be analyzed starting from the first administration of the study drug; toxicity will be analyzed according to CTC-NCI criteria).

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026