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.

Study Overview

• Status: Terminated
• Conditions: Chemotherapy-Induced Thrombocytopenia
• Intervention / Treatment: Drug: ONO-7746

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Deagu, Korea, Republic of, 700-712
    • Deagu Clinical Site 18-01
  • Jeollanam-do, Korea, Republic of, 519-763
    • Jeollanam-do Clinical Site 19-01
  • Seoul, Korea, Republic of, 135-720
    • Seoul Clinical Site 20-01
  • Seoul, Korea, Republic of, 152-703
    • Seoul Clinical Site 21-01
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Arkhangelsk Clinical Site 10-01
  • Moscow, Russian Federation, 129128
    • Moscow Clinical Site 14-01
  • Samara, Russian Federation, 443031
    • Samara Clinical Site 15-01
  • St. Petersburg, Russian Federation, 198255
    • St. Petersburg Clinical Site 11-01
  • Tambov, Russian Federation, 392000
    • Tambov Clinical Site 16-01
  • Tula, Russian Federation, 300040
    • Tula Clinical Site 12-01
  • Ufa, Russian Federation, 450054
    • Ufa Clinical Site 17-01
• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • Fort Collins Clinical Site 13-01
  • Georgia
    • Augusta, Georgia, United States, 30901
      • Augusta Clinical Site 01-01
  • Iowa
    • Ames, Iowa, United States, 50010
      • Ames Clinical Site 07-01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E	Drug: ONO-7746; 10mg, 20mg, 50mg, 100mg, 200mg and 300mg once-daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Ono Pharma USA Inc

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: April 21, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (Estimate): April 29, 2011

Study Record Updates

• Last Update Posted (Estimate): April 1, 2014
• Last Update Submitted That Met QC Criteria: March 31, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: ONO-7746; Thrombocytopenia; Chemotherapy Induced Thrombocytopenia
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: ONO-7746POU003