Clinical trialPhase 1Completed
Phase I-II to Evaluate Efficacy/Safety of Sorafenib+Gemcitabine+Radiotherapy in Locally Advanced Pancreatic Carcinoma
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
- Outcome
- Finished, no results posted
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- December 2007
- Expected end
- January 2012
- Enrollment
- 12 participants
- Sites
- 4
- Primary outcomes
- SAFETY; EFFICACY; TO DETERMINE MTD
- Sponsor
- Other
- Results posted
- No
- Last update
- 29 November 2012
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Brief summary public domain (ClinicalTrials.gov)
Phase I: Safety profile and to determine maximum tolerated dose (MTD) / Recommended Dose (DR) of Sorafenib in combination with Gemcitabine and Radiotherapy Phase II: Activity profile evaluating Progression-free rates (PFR) at 6 months, Response rate, Overall survival, Toxicity profile
Detailed description public domain (ClinicalTrials.gov)
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