Bladder Cancer Clinical Trial
Official title:
Phase Ib Study of Dovitinib in Combination With Gemcitabine Plus Cisplatin or Gemcitabine Plus Carboplatin in Patients With Advanced Solid Tumors
This is a phase Ib dose escalation study of dovitinib given in combination with either gemcitabine plus cisplatin or carboplatin in patients with advanced solid tumors. Patients with advanced solid tumors, for whom treatment with gemcitabine plus cisplatin or carboplatin would otherwise be warranted, will be enrolled. The dose of dovitinib will be escalated in successive cohorts using standard "3+3" dose escalation rules. Patients will continue treatment, in the absence of prohibitive toxicity, until disease progression. The study will define the recommended phase II dose of these combination regimens.
This is a phase Ib study of dovitinib given in combination with gemcitabine plus cisplatin
or carboplatin in patients with advanced solid tumors. This study will utilize standard 3+3
dose escalation rules to define the recommended phase II dose. Dose escalation will proceed
independently in the two cohorts (cisplatin cohort: gemcitabine + cisplatin + dovitinib;
carboplatin cohort: gemcitabine + carboplatin + dovitinib). Patients will receive treatment
for up to 6 cycles, in the absence of toxicity, until disease progression
Primary Objective:
To determine the recommended phase II dose of dovitinib given in combination with
gemcitabine plus cisplatin or carboplatin.
Secondary Objectives:
- To determine the response rate to treatment as per Response Evaluation Criteria in
Solid Tumors (RECIST)
- To determine the toxicity of treatment at per the Common Terminology for Adverse Events
(CTCAE v4)
- To determine the pharmacokinetics of dovitinib in combination with gemcitabine plus
cisplatin or carboplatin.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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