A Study of the Safety and Efficacy of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label, Multiple-Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia

Conditions
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Chemotherapy-Induced Thrombocytopenia

Intervention / Treatment
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* Drug: ONO-7746


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E<br> | Drug: ONO-7746<br>* 10mg, 20mg, 50mg, 100mg, 200mg and 300mg once-daily for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ONO-7746, Chemotherapy Induced Thrombocytopenia, Thrombocytopenia