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

Chemotherapy-Induced Thrombocytopenia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01345214
• Other study ID #: ONO-7746POU003
• Status: Terminated
• Phase: Phase 1
• First received: April 21, 2011
• Last updated: March 31, 2014
• Start date: May 2011

Study information

• Verified date: March 2014
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRussia: Ministry of Health of the Russian FederationSouth Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy-Induced Thrombocytopenia
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• ONO-7746
10mg, 20mg, 50mg, 100mg, 200mg and 300mg once-daily for 14 days

Locations

Country	Name	City	State
Korea, Republic of	Deagu Clinical Site 18-01	Deagu
Korea, Republic of	Jeollanam-do Clinical Site 19-01	Jeollanam-do
Korea, Republic of	Seoul Clinical Site 20-01	Seoul
Korea, Republic of	Seoul Clinical Site 21-01	Seoul
Russian Federation	Arkhangelsk Clinical Site 10-01	Arkhangelsk
Russian Federation	Moscow Clinical Site 14-01	Moscow
Russian Federation	Samara Clinical Site 15-01	Samara
Russian Federation	St. Petersburg Clinical Site 11-01	St. Petersburg
Russian Federation	Tambov Clinical Site 16-01	Tambov
Russian Federation	Tula Clinical Site 12-01	Tula
Russian Federation	Ufa Clinical Site 17-01	Ufa
United States	Ames Clinical Site 07-01	Ames	Iowa
United States	Augusta Clinical Site 01-01	Augusta	Georgia
United States	Fort Collins Clinical Site 13-01	Fort Collins	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharma USA Inc

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes