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

Phase 1

Terminated

• Conditions: Chemotherapy-Induced Thrombocytopenia
• Interventions: Drug: ONO-7746

• Registration Number: NCT01345214
• Lead Sponsor: Ono Pharma USA Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Study Start: 2011-05
• Primary Completion: 2014-02
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-31
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E	ONO-7746	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (14)

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

Deagu Clinical Site 18-01; 🇰🇷 Deagu, Korea, Republic of

Jeollanam-do Clinical Site 19-01; 🇰🇷 Jeollanam-do, Korea, Republic of

Seoul Clinical Site 20-01; 🇰🇷 Seoul, Korea, Republic of

Seoul Clinical Site 21-01; 🇰🇷 Seoul, Korea, Republic of

Arkhangelsk Clinical Site 10-01; 🇷🇺 Arkhangelsk, Russian Federation

Moscow Clinical Site 14-01; 🇷🇺 Moscow, Russian Federation

Samara Clinical Site 15-01; 🇷🇺 Samara, Russian Federation

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