Trial record 1 of 1 for:    ONO-7746POU003
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A Study of the Safety and Efficacy of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia

This study has been terminated.
(The study was terminated due to slow accrual of subjects.)
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier:
NCT01345214
First received: April 21, 2011
Last updated: March 31, 2014
Last verified: March 2014

April 21, 2011
March 31, 2014
May 2011
February 2014   (final data collection date for primary outcome measure)
Safety and tolerability of ONO-7746 across ascending multiple doses using vital signs, physical examinations, ECGs, ECOG performance status, CT/MRI, laboratory tests [ Time Frame: up to four 21-day cycles (up to 84 days) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01345214 on ClinicalTrials.gov Archive Site
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 [ Time Frame: up to four 21-day cycles (up to 84 days) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study of the Safety and Efficacy of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia
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

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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chemotherapy-Induced Thrombocytopenia
Drug: ONO-7746
10mg, 20mg, 50mg, 100mg, 200mg and 300mg once-daily for 14 days
Experimental: E
Intervention: Drug: ONO-7746
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
Not Provided
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Russian Federation,   Korea, Republic of
 
NCT01345214
ONO-7746POU003
No
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
Ono Pharma USA Inc
Not Provided
Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP