Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors
Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
Participant gender:
Summary
This is an open-label, two-arm, multicenter feasibility study to evaluate the safety and
tolerability of pazopanib in combination with carboplatin and paclitaxel in female subjects
with newly diagnosed advanced gynaecological tumors. Subjects will have received no prior
therapy for their disease. A minimum of 12 and a maximum of 46 subjects will be enrolled.
Dose schemas for each study arm are described in the protocol. For each arm, six subjects
will be evaluated in treatment cohorts, which will be expanded to 20 subjects if initial
toxicity is acceptable. Overall safety and tolerability of the regimen will be based on dose
limiting toxicities, adverse events, and percentage of subjects that complete 6 courses of
study treatment. Antitumor activity will be assessed using RECIST criteria and cancer antigen
125 (CA-125) responses.