Open-label, Multicentric Phase I-II Trial to Evaluate the Efficacy and Safety of the Combination of Sorafenib (BAY 43-9006), Gemcitabine and Concurrent Radiotherapy, in Locally Advanced Pancreatic Carcinoma
Safety profile and to determine maximum tolerated dose (MTD) / Recommended Dose (DR) of
Sorafenib in combination with Gemcitabine and Radiotherapy
Definition of maximum tolerated dose (MTD):
The MTD is defined as the highest dose level which can be given to 6 patients such that no
more than 1 patient experiences a DLT .
Definition of Recommended Dose (DR):
Is the MTD
Definition of Dose-limiting toxicity (DLT):
DLT will be defined as any of the following occurring during the period of treatment and
regarded as related to the combination regimen.
- Grade 4 thrombocytopenia persisting greater than 4 days, or with bleeding requiring
platelet transfusion
- Grade 4 neutropenia lasting more than 7 days
- Febrile neutropenia (≥ 38.5oC) with an absolute neutrophil count ≤ 1000/mm3
- Any grade 3 or 4 non-hematologic toxicity related to the combination [occurring despite
optimal supportive care, if applicable] except hyperglycemia, hypoglycemia, deep venous
thrombosis, or hyperbilirubinemia secondary to stent malfunction.
- Hypertension that is symptomatic and not managed by maximal use of three different
classes of antihypertensives, or any episode of malignancy hypertension
(Detailed Dose Modifications and G-CSF use in case of febrile neutropenia will be outlined
in the full protocol version)
Phase II
Primary objective:
Activity profile evaluating Progression-free rates (PFR) at 6 months
Secondary objective:
Response rate Overall survival Toxicity profile
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
SAFETY
End of Study
Yes
Spain: Spanish Agency of Medicines
GEMCAD 0701
NCT00789763
December 2007
January 2012
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