A Study of the Safety and Efficacy of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia
This study is currently recruiting participants.
Verified March 2013 by Ono Pharmaceutical Co. Ltd
Sponsor:
Ono Pharma USA Inc
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier:
NCT01345214
First received: April 21, 2011
Last updated: March 1, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chemotherapy-Induced Thrombocytopenia |
Drug: ONO-7746 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Ono Pharmaceutical Co. Ltd:
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 [ Time Frame: up to four 21-day cycles (up to 84 days) ] [ Designated as safety issue: Yes ]
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 [ Time Frame: up to four 21-day cycles (up to 84 days) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 56 |
| Study Start Date: | May 2011 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: E |
Drug: ONO-7746
10mg, 20mg, 50mg, 100mg, 200mg and 300mg once-daily for 14 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345214
Contacts
| Contact: Brenda Souza | (609) 512-4129 |
Locations
| United States, Colorado | |
| Fort Collins Clinical Site 13-01 | Recruiting |
| Fort Collins, Colorado, United States, 80528 | |
| United States, Georgia | |
| Augusta Clinical Site 01-01 | Recruiting |
| Augusta, Georgia, United States, 30901 | |
| United States, Iowa | |
| Ames Clinical Site 07-01 | Recruiting |
| Ames, Iowa, United States, 50010 | |
| United States, New York | |
| Bronx Clinical Site 02-01 | Recruiting |
| Bronx, New York, United States, 10461 | |
| Korea, Republic of | |
| Deagu Clinical Site 18-01 | Recruiting |
| Deagu, Korea, Republic of, 700-712 | |
| Jeollanam-do Clinical Site 19-01 | Recruiting |
| Jeollanam-do, Korea, Republic of, 519-763 | |
| Seoul Clinical Site 20-01 | Recruiting |
| Seoul, Korea, Republic of, 135-720 | |
| Seoul Clinical Site 21-01 | Recruiting |
| Seoul, Korea, Republic of, 152-703 | |
| Russian Federation | |
| Arkhangelsk Clinical Site 10-01 | Recruiting |
| Arkhangelsk, Russian Federation, 163045 | |
| Moscow Clinical Site 14-01 | Recruiting |
| Moscow, Russian Federation, 129128 | |
| Samara Clinical Site 15-01 | Recruiting |
| Samara, Russian Federation, 443031 | |
| St. Petersburg Clinical Site 11-01 | Recruiting |
| St. Petersburg, Russian Federation, 198255 | |
| Tambov Clinical Site 16-01 | Recruiting |
| Tambov, Russian Federation, 392000 | |
| Tula Clinical Site 12-01 | Recruiting |
| Tula, Russian Federation, 300040 | |
| Ufa Clinical Site 17-01 | Recruiting |
| Ufa, Russian Federation, 450054 | |
Sponsors and Collaborators
Ono Pharma USA Inc
Investigators
| Study Director: | Ono Pharma USA, Inc. | Ono Pharmaceutical Co. Ltd |
More Information
No publications provided
| Responsible Party: | Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ) |
| ClinicalTrials.gov Identifier: | NCT01345214 History of Changes |
| Other Study ID Numbers: | ONO-7746POU003 |
| Study First Received: | April 21, 2011 |
| Last Updated: | March 1, 2013 |
| Health Authority: | United States: Food and Drug Administration Russia: Ministry of Health of the Russian Federation South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Ono Pharmaceutical Co. Ltd:
|
ONO-7746 Chemotherapy Induced Thrombocytopenia Thrombocytopenia |
Additional relevant MeSH terms:
|
Thrombocytopenia Blood Platelet Disorders Hematologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013