A Study of the Safety and Efficacy of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 17
- 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
- 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)
St. Petersburg Clinical Site 11-01
🇷🇺St. Petersburg, Russian Federation
Deagu Clinical Site 18-01
🇰🇷Deagu, Korea, Republic of
Tambov Clinical Site 16-01
🇷🇺Tambov, Russian Federation
Tula Clinical Site 12-01
🇷🇺Tula, Russian Federation
Arkhangelsk Clinical Site 10-01
🇷🇺Arkhangelsk, Russian Federation
Samara Clinical Site 15-01
🇷🇺Samara, Russian Federation
Seoul Clinical Site 21-01
🇰🇷Seoul, Korea, Republic of
Ufa Clinical Site 17-01
🇷🇺Ufa, Russian Federation
Seoul Clinical Site 20-01
🇰🇷Seoul, Korea, Republic of
Jeollanam-do Clinical Site 19-01
🇰🇷Jeollanam-do, Korea, Republic of
Moscow Clinical Site 14-01
🇷🇺Moscow, Russian Federation
Augusta Clinical Site 01-01
🇺🇸Augusta, Georgia, United States
Ames Clinical Site 07-01
🇺🇸Ames, Iowa, United States
Fort Collins Clinical Site 13-01
🇺🇸Fort Collins, Colorado, United States