The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918 will be administered twice daily. Then maximum tolerated doses in combination with either gemcitabine or pemetrexed will also be investigated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
liquid suspension, daily, oral dose
intravenous, doses are on an intermittent schedule
intravenous, dose administered every 21-days
Research Site
Aurora, Colorado, United States
Research Site
Nashville, Tennessee, United States
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, Karnofsky performance status
Time frame: Weekly for first two treatment cycles, then every 2-4 weeks
Pharmacokinetic effect of AZD6918 when administered alone and in combination with chemotherapy
Time frame: According to protocol specified schedule, the number of PK samples collected during Cycle 1 (up to 28 days) based on treatment with AZD6918 alone or in combination with chemotherapy
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