Clinical trial NCT01345214: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chemotherapy-Induced Thrombocytopenia
Keywords: ONO-7746
Chemotherapy Induced Thrombocytopenia
Thrombocytopenia
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2011-04-29
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety and tolerability of ONO-7746 across ascending multiple doses using vital signs, physical examinations, ECGs, ECOG performance status, CT/MRI, laboratory tests
timeFrame: up to four 21-day cycles (up to 84 days)
Secondary outcomes:
measure: 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
timeFrame: up to four 21-day cycles (up to 84 days)
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Fort Collins Clinical Site 13-01
state: Colorado
city: Augusta
country: United States
facility: Augusta Clinical Site 01-01
state: Georgia
city: Ames
country: United States
facility: Ames Clinical Site 07-01
state: Iowa
city: Deagu
country: Korea, Republic of
facility: Deagu Clinical Site 18-01
city: Jeollanam-do
country: Korea, Republic of
facility: Jeollanam-do Clinical Site 19-01
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 20-01
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 21-01
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Clinical Site 10-01
city: Moscow
country: Russian Federation
facility: Moscow Clinical Site 14-01
city: Samara
country: Russian Federation
facility: Samara Clinical Site 15-01
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Clinical Site 11-01
city: Tambov
country: Russian Federation
facility: Tambov Clinical Site 16-01
city: Tula
country: Russian Federation
facility: Tula Clinical Site 12-01
city: Ufa
country: Russian Federation
facility: Ufa Clinical Site 17-01
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharma USA, Inc.
role: STUDY_DIRECTOR
References: