A Phase I, Open-label, Study of Pazopanib in Combination With Epirubicin or Doxorubicin for Advanced Solid Tumors
Status:
Completed
Trial end date:
2014-02-25
Target enrollment:
Participant gender:
Summary
This is an open-label, four-arm, Phase I, dose escalation study to evaluate the safety and
tolerability and to determine the optimal tolerated regimen (OTR) of pazopanib in combination
with epirubicin or doxorubicin in patients with advanced solid tumors. Patients will be
enrolled in cohorts of 3 to receive escalating doses of pazopanib and epirubicin or
doxorubicin. Dose escalation schemas for each study arm are described in the protocol. For
each arm, the OTR will be defined as the highest dose combination of the agents where no more
than one out of six patients experiences a dose-limiting toxicity. Twelve additional patients
in each arm will be studied with the OTR to evaluate toxicity and pharmacokinetics. This will
allow an assessment of potential drug-drug interactions. Antitumor activity will be assessed
using RECIST criteria.