Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Chemotherapy-Induced Thrombocytopenia
Drug: ONO-7746
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 17
Study Start Date: May 2011
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E Drug: ONO-7746
10mg, 20mg, 50mg, 100mg, 200mg and 300mg once-daily for 14 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345214

Locations
United States, Colorado
Fort Collins Clinical Site 13-01
Fort Collins, Colorado, United States, 80528
United States, Georgia
Augusta Clinical Site 01-01
Augusta, Georgia, United States, 30901
United States, Iowa
Ames Clinical Site 07-01
Ames, Iowa, United States, 50010
Korea, Republic of
Deagu Clinical Site 18-01
Deagu, Korea, Republic of, 700-712
Jeollanam-do Clinical Site 19-01
Jeollanam-do, Korea, Republic of, 519-763
Seoul Clinical Site 20-01
Seoul, Korea, Republic of, 135-720
Seoul Clinical Site 21-01
Seoul, Korea, Republic of, 152-703
Russian Federation
Arkhangelsk Clinical Site 10-01
Arkhangelsk, Russian Federation, 163045
Moscow Clinical Site 14-01
Moscow, Russian Federation, 129128
Samara Clinical Site 15-01
Samara, Russian Federation, 443031
St. Petersburg Clinical Site 11-01
St. Petersburg, Russian Federation, 198255
Tambov Clinical Site 16-01
Tambov, Russian Federation, 392000
Tula Clinical Site 12-01
Tula, Russian Federation, 300040
Ufa Clinical Site 17-01
Ufa, Russian Federation, 450054
Sponsors and Collaborators
Ono Pharma USA Inc
Investigators
Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier: NCT01345214     History of Changes
Other Study ID Numbers: ONO-7746POU003
Study First Received: April 21, 2011
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-7746
Chemotherapy Induced Thrombocytopenia
Thrombocytopenia

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014