search
Back to results

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

Primary Purpose

Chemotherapy-Induced Thrombocytopenia

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ONO-7746
Sponsored by
Ono Pharma USA Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-Induced Thrombocytopenia focused on measuring ONO-7746, Chemotherapy Induced Thrombocytopenia, Thrombocytopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fort Collins Clinical Site 13-01
  • Augusta Clinical Site 01-01
  • Ames Clinical Site 07-01
  • Deagu Clinical Site 18-01
  • Jeollanam-do Clinical Site 19-01
  • Seoul Clinical Site 20-01
  • Seoul Clinical Site 21-01
  • Arkhangelsk Clinical Site 10-01
  • Moscow Clinical Site 14-01
  • Samara Clinical Site 15-01
  • St. Petersburg Clinical Site 11-01
  • Tambov Clinical Site 16-01
  • Tula Clinical Site 12-01
  • Ufa Clinical Site 17-01

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

E

Arm Description

Outcomes

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

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

Full Information

First Posted
April 21, 2011
Last Updated
March 31, 2014
Sponsor
Ono Pharma USA Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT01345214
Brief Title
A Study of the Safety and Efficacy of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to slow accrual of subjects.
Study Start Date
May 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharma USA Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-Induced Thrombocytopenia
Keywords
ONO-7746, Chemotherapy Induced Thrombocytopenia, Thrombocytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ONO-7746
Intervention Description
10mg, 20mg, 50mg, 100mg, 200mg and 300mg once-daily for 14 days
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ono Pharma USA, Inc.
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Fort Collins Clinical Site 13-01
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Augusta Clinical Site 01-01
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Ames Clinical Site 07-01
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Deagu Clinical Site 18-01
City
Deagu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Jeollanam-do Clinical Site 19-01
City
Jeollanam-do
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
Seoul Clinical Site 20-01
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Seoul Clinical Site 21-01
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Arkhangelsk Clinical Site 10-01
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Moscow Clinical Site 14-01
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Samara Clinical Site 15-01
City
Samara
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
St. Petersburg Clinical Site 11-01
City
St. Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Tambov Clinical Site 16-01
City
Tambov
ZIP/Postal Code
392000
Country
Russian Federation
Facility Name
Tula Clinical Site 12-01
City
Tula
ZIP/Postal Code
300040
Country
Russian Federation
Facility Name
Ufa Clinical Site 17-01
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs