Chemotherapy-Induced ThrombocytopeniaPhase 1NCT01345214
A Study of the Safety and Efficacy of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia
A Phase 1 study testing ONO-7746 in people with Chemotherapy-Induced Thrombocytopenia, run by Ono Pharma USA Inc at 14 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Thrombocytopenia
- What is being tested?
- ONO-7746
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 14 sitesin 3 countries
- Study dates
- May 2011to Feb 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Russia7 sites
Arkhangelsk Clinical Site 10-01
Arkhangelsk, 163045
Moscow Clinical Site 14-01
Moscow, 129128
St. Petersburg Clinical Site 11-01
Saint Petersburg, 198255
Samara Clinical Site 15-01
Samara, 443031
Tambov Clinical Site 16-01
Tambov, 392000
Tula Clinical Site 12-01
Tula, 300040
Ufa Clinical Site 17-01
Ufa, 450054
South Korea4 sites
Deagu Clinical Site 18-01
Deagu, 700-712
Jeollanam-do Clinical Site 19-01
Jeollanam-do, 519-763
Seoul Clinical Site 20-01
Seoul, 135-720
Seoul Clinical Site 21-01
Seoul, 152-703
United States3 sites
Ames Clinical Site 07-01
Ames, Iowa, 50010
Augusta Clinical Site 01-01
Augusta, Georgia, 30901
Fort Collins Clinical Site 13-01
Fort Collins, Colorado, 80528
About this study
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
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.
- Conditions
- Chemotherapy-Induced Thrombocytopenia
- Being tested
- ONO-7746
- Keywords
- ONO-7746, Chemotherapy Induced Thrombocytopenia, Thrombocytopenia
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-7746Drug
10mg, 20mg, 50mg, 100mg, 200mg and 300mg once-daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| E | Experimental | Not described Receives: Drug: ONO-7746 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ONO-7746 across ascending multiple doses using vital signs, physical examinations, ECGs, ECOG performance status, CT/MRI, laboratory tests
Measured: 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
Measured: up to four 21-day cycles (up to 84 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2014
Why it stopped: The study was terminated due to slow accrual of subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharma USA Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ono Pharma USA, Inc., Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345214
- Sponsor's protocol ID
- ONO-7746POU003
- Status last verified
- Mar 2014
- First submitted
- 21 Apr 2011
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01345214
- Acronym / sponsor ID
- ONO-7746POU003
- Conditions
- Chemotherapy-Induced Thrombocytopenia
- Keywords
- ONO-7746, Chemotherapy Induced Thrombocytopenia, Thrombocytopenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to slow accrual of subjects.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Ono Pharma USA IncIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Feb 2014 (actual)
- First posted
- 29 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E | Experimental | Drug: ONO-7746 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-774610mg, 20mg, 50mg, 100mg, 200mg and 300mg once-daily for 14 days | Drug | E |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
The study was stopped early (reason given: The study was terminated due to slow accrual of subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ono Pharma USA, Inc. study director
Ono Pharmaceutical Co., Ltd.
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONO-7746 in people with Chemotherapy-Induced Thrombocytopenia, run by Ono Pharma USA Inc at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Russia, South Korea, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to slow accrual of subjects.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2014.