NCT01345214

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Geographic Reach
3 countries

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Last Updated

April 1, 2014

Status Verified

March 1, 2014

Enrollment Period

2.8 years

First QC Date

April 21, 2011

Last Update Submit

March 31, 2014

Conditions

Chemotherapy-Induced Thrombocytopenia

Keywords

ONO-7746Chemotherapy Induced ThrombocytopeniaThrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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)

Study Arms (1)

E

EXPERIMENTAL
Drug: ONO-7746

Interventions

ONO-7746DRUG

10mg, 20mg, 50mg, 100mg, 200mg and 300mg once-daily for 14 days

E

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Fort Collins Clinical Site 13-01

Fort Collins, Colorado, 80528, United States

Location

Augusta Clinical Site 01-01

Augusta, Georgia, 30901, United States

Location

Ames Clinical Site 07-01

Ames, Iowa, 50010, United States

Location

Arkhangelsk Clinical Site 10-01

Arkhangelsk, 163045, Russia

Location

Moscow Clinical Site 14-01

Moscow, 129128, Russia

Location

St. Petersburg Clinical Site 11-01

Saint Petersburg, 198255, Russia

Location

Samara Clinical Site 15-01

Samara, 443031, Russia

Location

Tambov Clinical Site 16-01

Tambov, 392000, Russia

Location

Tula Clinical Site 12-01

Tula, 300040, Russia

Location

Ufa Clinical Site 17-01

Ufa, 450054, Russia

Location

Deagu Clinical Site 18-01

Deagu, 700-712, South Korea

Location

Jeollanam-do Clinical Site 19-01

Jeollanam-do, 519-763, South Korea

Location

Seoul Clinical Site 20-01

Seoul, 135-720, South Korea

Location

Seoul Clinical Site 21-01

Seoul, 152-703, South Korea

Location

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Study Officials

  • Ono Pharma USA, Inc.

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2011

First Posted

April 29, 2011

Study Start

May 1, 2011

Primary Completion

February 1, 2014

Last Updated

April 1, 2014

Record last verified: 2014-03

Locations

RU(7)KR(4)US(3)