Advanced Solid TumorsPhase 1NCT02261298
ONO-4538 Phase I Study in Patients With Solid Tumor
A Phase 1 study testing ONO-4538 in people with Advanced Solid Tumors and Recurrent Solid Tumors, run by Ono Pharmaceutical Co., Ltd. at 5 sites in South Korea.
Trial summary
The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Solid Tumors, Recurrent Solid Tumors
- What is being tested?
- ONO-4538
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Oct 2014to Apr 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The treatment phase has been completed in the ONO-4538-13 study
Who cannot join
- The development of PD is identified by the principal or sub investigator according to the RECIST guideline (version 1.1) only in case in which the unplanned tumor assessment with diagnostic image is performed in the treatment phase of ONO-4538-13 study.
- It is determined that continuing the treatment is not appropriate because the worsening of clinical symptoms attributed to disease progression occurs.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Seongnam-si Clinical Site 105
Seongnam-si, Gyeonggi-do
Seoul Clinical Site 101
Seoul
Seoul Clinical Site 102
Seoul
Seoul Clinical Site 103
Seoul
Seoul Clinical Site 104
Seoul
About this study
Official title: ONO-4538 Multicenter, Open-label, Uncontrolled, Phase I Multiple Dose Study in Solid Tumor
The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.
- Conditions
- Advanced Solid Tumors, Recurrent Solid Tumors
- Being tested
- ONO-4538
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4538Drug
| Study group | Role | What they receive |
|---|---|---|
| ONO-4538 1mg/kg | Experimental | ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, 3 times once every 2 weeks in each 6-week cycle Receives: Drug: ONO-4538 |
| ONO-4538 3mg/kg | Experimental | ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, 3 times once every 2 weeks in each 6-week cycle Receives: Drug: ONO-4538 |
| ONO-4538 10mg/kg | Experimental | ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, 3 times once every 2 weeks in each 6-week cycle Receives: Drug: ONO-4538 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcome: The number of subjects with overall adverse events
Measured: Approximately 6 months
Safety outcome: The number of deaths
Measured: Approximately 6 months
PK outcome: Cmax of ONO-4538
Measured: Approximately 10 months
Efficacy outcome: Response rate
Measured: Approximately 6 months
Efficacy outcome: Progression free survival
Measured: Approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2015
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitsunobu Tanimoto, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261298
- Sponsor's protocol ID
- ONO-4538-14
- Status last verified
- May 2024
- First submitted
- 30 Sep 2014
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lee KW, Lee DH, Kang JH, Park JO, Kim SH, Hong YS, Kim ST, Oh DY, Bang YJ. Phase I Pharmacokinetic Study of Nivolumab in Korean Patients with Advanced Solid Tumors. Oncologist. 2018 Feb;23(2):155-e17. doi: 10.1634/theoncologist.2017-0528. Epub 2017 Nov 20.
PubMed 29158363
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONO-4538 Multicenter, Open-label, Uncontrolled, Phase I Multiple Dose Study in Solid Tumor
- ClinicalTrials.gov ID
- NCT02261298
- Acronym / sponsor ID
- ONO-4538-14
- Conditions
- Advanced Solid Tumors, Recurrent Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 10 Oct 2014 (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 objective of this study is to investigate the safety, pharmacokinetics, pharmacology and efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ONO-4538 1mg/kg | Experimental | Drug: ONO-4538ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, 3 times once every 2 weeks in each 6-week cycle |
| ONO-4538 3mg/kg | Experimental | Drug: ONO-4538ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, 3 times once every 2 weeks in each 6-week cycle |
| ONO-4538 10mg/kg | Experimental | Drug: ONO-4538ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, 3 times once every 2 weeks in each 6-week cycle |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The treatment phase has been completed in the ONO-4538-13 study
Key exclusion criteria (2 listed)
- The development of PD is identified by the principal or sub investigator according to the RECIST guideline (version 1.1) only in case in which the unplanned tumor assessment with diagnostic image is performed in the treatment phase of ONO-4538-13 study.
- It is determined that continuing the treatment is not appropriate because the worsening of clinical symptoms attributed to disease progression occurs.
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-4538 | Drug | ONO-4538 10mg/kg, ONO-4538 1mg/kg, ONO-4538 3mg/kg |
Primary outcome
Safety outcome: The number of subjects with overall adverse events
Time frame: Approximately 6 months
Safety outcome: The number of deaths
Time frame: Approximately 6 months
PK outcome: Cmax of ONO-4538
Time frame: Approximately 10 months
Efficacy outcome: Response rate
Time frame: Approximately 6 months
Efficacy outcome: Progression free survival
Time frame: Approximately 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 29158363Lee KW, Lee DH, Kang JH, Park JO, Kim SH, Hong YS, Kim ST, Oh DY, Bang YJ. Phase I Pharmacokinetic Study of Nivolumab in Korean Patients with Advanced Solid Tumors. Oncologist. 2018 Feb;23(2):155-e17. doi: 10.1634/theoncologist.2017-0528. Epub 2017 Nov 20.
- Individual participant dataSharing planned: No
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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.
Mitsunobu Tanimoto study director
Ono Pharmaceutical Co., Ltd.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONO-4538 in people with Advanced Solid Tumors and Recurrent Solid Tumors, run by Ono Pharmaceutical Co., Ltd. at 5 sites in South Korea.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 outcome: The number of subjects with overall adverse events (time frame: Approximately 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02261298, which also lists 1 linked publication.
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 3 May 2024.