C25
Conditions
Interventions
Group 1: TKI258 (Tablets, oral), Dose 200 - 500mg, daily (5 days on, 2 days off)
Capecitabine (Tablets, oral), Dose 1000mg/m², daily (14 days, 7 days pause)
Sponsors
Ruprecht-Karls Universität Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Male or female patients age 18-90, with histologically proven chemo-refractory pancreatic cancer patients must have recovered from side effects of previous chemotherapy. Life expectancy must be more than 12 weeks, organ functions must be adequate.
Exclusion criteria
Exclusion criteria: The patients must not suffer from any other severe chronic or acute medical or psychiatric disorder. They must be at least 2 weeks from last chemotherapy and must not receive any other conventional medicinal anti-cancer therapy during the treatment phase.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the maximum tolerable dose (MTD) and assess the safety and tolerability of TKI258 in combination with capecitabine (after each cycle). | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the preliminary antitumor activity of TKI258 in combination with capecitabine. To assess the response with regard to the expression and/or mutation of the tyrosine kinase receptors. Progression-free survival and overall survival. Overall tumor response. All assessments will be done after each cycle. | — |
Countries
Germany
Contacts
Public ContactRalf Jesenofsky
Universitätsmedizin Mannheim Medizinische Fakultät Mannheim der Universität Heidelberg II. Medizinische Klinik
Outcome results
None listed