This study will determine the maximum-tolerated dose (MTD) for oral bosutinib when used in combination with pemetrexed. The MTD is the highest dose of bosutinib with pemetrexed that can be given without causing severe side effects. This study will also test the safety of this combination and see what effects (good or bad) it has on participants and their cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
100mg daily for 4 cycles (21 days per cycle)
500 mg/m2 every 21 days for 4 cycles
Augusta University Georgia Cancer Center
Augusta, Georgia, United States
Dose-limiting toxicity of the combination of bosutinib and pemetrexed
CTCAE Grade 3 or 4 non-hematologic toxicities other than alopecia, nausea and vomiting.
Time frame: 21 days
Maximum tolerated dose of the combination of bosutinib and pemetrexed
Time frame: completion of dose escalation
Adverse events of the combination of bosutinib and pemetrexed
Time frame: 16 weeks
Anti-tumor response rate
Time frame: 6 and 12 weeks
Progression-free survival
Time frame: 6 and 12 weeks
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