Chemotherapy-Induced Thrombocytopenia
Conditions
Keywords
ONO-7746, Chemotherapy Induced Thrombocytopenia, Thrombocytopenia
Brief summary
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.
Interventions
DRUGONO-7746
10mg, 20mg, 50mg, 100mg, 200mg and 300mg once-daily for 14 days
Sponsors
Ono Pharma USA Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed written informed consent * Age ≥ 18 years * Patients with confirmed solid tumor and scheduled to receive at least two cycles of myelosuppressive chemotherapy on Day 1 every 21 days at the same dosage and schedule in the study. * Experienced thrombocytopenia as evidenced by a platelet count \< 100 Gi/L in the preceding cycle immediately before study enrollment. * ECOG performance status ≤ 2 * For females, surgically sterilized, postmenopausal or agree to use an acceptable form of birth control * Patients treated with novel anticancer agents (e.g. bevacizumab, erlotinib, trastuzumab, cetuximab) may be allowed if it is considered the standard treatment by the investigator and after consultation and approval from the Sponsor * PT/INR and aPTT are within 80% to 120% of the normal range
Exclusion criteria
* Experienced thrombocytopenia as evidenced by a platelet count \< 25 Gi/L at any time in the preceding cycle immediately before enrollment into the study * History or presence of clinically significant disease * Received any TRAs, or rHuIL-11 within the last 4 weeks prior to screening * Had received a bone marrow or peripheral blood stem cell infusion (within 1 year of screening). * Pregnant, wanting to become pregnant or lactating
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | 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) |
Countries
Russia, South Korea, United States
Outcome results
None listed