Cancer Clinical Trial
Official title:
A Phase I/II Study of Ganetespib in Combination With Doxorubicin in Solid Tumors (Phase I) and Refractory Small Cell Lung Cancer (Safety Dose Expansion, Phase II)
This is a Phase I/safety dose expansion study of the combination of the drug ganetespib and doxorubicin in patients with advanced solid tumors. The purpose of the Phase I part of the study is to determine the recommended phase II dose of ganetespib when given in combination with doxorubicin. The recommended Phase II dose determined at the end of the dose escalation phase will be used to conduct a safety dose expansion phase in relapsed/refractory small cell lung cancer to determine if there is a signal of efficacy in this population.
The dose escalation phase of the study will follow a standard 3+ 3 dose escalation scheme
with two dose levels of ganetespib (1-- mg/m2 and 150 mg/m2) administered weekly on Days 1
and 8 of a 21-day cycle, in combination with a fixed dose of doxorubicin at 50 mg/m2
administered on Day 1 alone. After 4-6 cycles of combination therapy, continuation of single
agent ganetespib will be permitted for subjects who are deriving clinical benefit.
Pharmacokinetic samples for plasma drug levels of ganetespib will be collected pre-dose and 4
hours after completion of treatment on Day 1 and Day 8 of cycle 1 only in subjects in the
dose escalation phase.
The recommended Phase II dose determined at the end of the dose escalation phase will be used
to conduct a safety dose expansion phase in relapsed/ refractory small cell lung cancer to
determine if there is a signal of efficacy in this population.
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