The primary objective of this study is to evaluate the safety and tolerability of ONO-7746 across multiple doses in patients with solid tumors and chemotherapy induced thrombocytopenia (CIT) scheduled to receive at least two cycles of myelosuppressive chemotherapy on Day 1 every 21 days at the same dosages and schedule in the study. The secondary objectives are to characterize the PK profiles of ONO-7746 and to explore the pharmacodynamic effect of ONO-7746 on CIT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
10mg, 20mg, 50mg, 100mg, 200mg and 300mg once-daily for 14 days
Fort Collins Clinical Site 13-01
Fort Collins, Colorado, United States
Augusta Clinical Site 01-01
Augusta, Georgia, United States
Ames Clinical Site 07-01
Ames, Iowa, United States
Safety and tolerability of ONO-7746 across ascending multiple doses using vital signs, physical examinations, ECGs, ECOG performance status, CT/MRI, laboratory tests
Time frame: up to four 21-day cycles (up to 84 days)
Characterization of PK profiles on ONO-7746 and exploration of the PD effect of ONO-7746, including changes in platelet counts and any potential effects on ECGs
Time frame: up to four 21-day cycles (up to 84 days)
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Arkhangelsk Clinical Site 10-01
Arkhangelsk, Russia
Moscow Clinical Site 14-01
Moscow, Russia
St. Petersburg Clinical Site 11-01
Saint Petersburg, Russia
Samara Clinical Site 15-01
Samara, Russia
Tambov Clinical Site 16-01
Tambov, Russia
Tula Clinical Site 12-01
Tula, Russia
Ufa Clinical Site 17-01
Ufa, Russia
...and 4 more locations