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

Stopped early · Phase 1

Conditions studied: Chemotherapy-Induced Thrombocytopenia

In brief

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.

Key facts

Study ID

NCT01345214

Run by

Ono Pharma USA Inc

People needed

17

Starts

2011-05-01

Last updated by the study team

2014-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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
• Deagu Clinical Site 18-01 — Deagu, South Korea
• Jeollanam-do Clinical Site 19-01 — Jeollanam-do, South Korea
• Seoul Clinical Site 20-01 — Seoul, South Korea
• Seoul Clinical Site 21-01 — Seoul, South Korea

Full record on ClinicalTrials.gov

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