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 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
To determine the recommended phase II dose of dovitinib given in combination with
gemcitabine plus cisplatin or carboplatin.
- 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
- 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
Recommended phase II dose of combination regimen
The primary objectives of this study are to determine the recommended phase II dose of dovitinib given in combination with gemcitabine plus carboplatin or cisplatin.
Within the first 21 days of treatment
Matthew D. Galsky, M.D.
Mount Sinai School of Medicine
United States: Food and Drug Administration
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