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The study was terminated due to slow accrual of subjects.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-7746 | Drug | 10mg, 20mg, 50mg, 100mg, 200mg and 300mg once-daily for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of ONO-7746 across ascending multiple doses using vital signs, physical examinations, ECGs, ECOG performance status, CT/MRI, laboratory tests | up to four 21-day cycles (up to 84 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to four 21-day cycles (up to 84 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ono Pharma USA, Inc. | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fort Collins Clinical Site 13-01 | Fort Collins | Colorado | 80528 | United States | ||
| Augusta Clinical Site 01-01 |
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| Augusta |
| Georgia |
| 30901 |
| United States |
| Ames Clinical Site 07-01 | Ames | Iowa | 50010 | United States |
| Arkhangelsk Clinical Site 10-01 | Arkhangelsk | 163045 | Russia |
| Moscow Clinical Site 14-01 | Moscow | 129128 | Russia |
| St. Petersburg Clinical Site 11-01 | Saint Petersburg | 198255 | Russia |
| Samara Clinical Site 15-01 | Samara | 443031 | Russia |
| Tambov Clinical Site 16-01 | Tambov | 392000 | Russia |
| Tula Clinical Site 12-01 | Tula | 300040 | Russia |
| Ufa Clinical Site 17-01 | Ufa | 450054 | Russia |
| Deagu Clinical Site 18-01 | Deagu | 700-712 | South Korea |
| Jeollanam-do Clinical Site 19-01 | Jeollanam-do | 519-763 | South Korea |
| Seoul Clinical Site 20-01 | Seoul | 135-720 | South Korea |
| Seoul Clinical Site 21-01 | Seoul | 152-703 | South Korea |
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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