NeoplasmsPhase 1NCT02390154
Roniciclib Mass Balance Study
A Phase 1 study testing roniciclib (BAY 1000394) in people with Neoplasms, run by Bayer at 1 site in Hungary.
Trial summary
The purpose of this trial is to investigate the fate of the roniciclib (study drug) in the body in a so called mass-balance study. This means to investigate how the study drug is absorbed, distributed, broken down (metabolized) and removed (excreted or eliminated) from the body. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Neoplasms
- What is being tested?
- roniciclib (BAY 1000394)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteHungary
- Study dates
- Apr 2015to Jun 2016
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Male or female subjects aged ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Subjects with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable
- Adequate bone marrow, liver, and renal functions as assessed by laboratory requirements to be conducted within 14 days prior to the first dose of study drug:
Who cannot join
- Previous deep vein thrombosis (within the last 6 months), arterial thrombotic events (including strokes), or pulmonary embolism
- History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class III or IV, angina (within past 6 months prior to study entry), myocardial infarction, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- Anticancer chemotherapy or immunotherapy within 4 weeks of study entry. Mitomycin C or nitrosoureas should not be given within 6 weeks of study entry. Accepted exemptions are bisphosphonates, luteinising hormone releasing hormone (LHRH) agonists for prostate cancer, and mitotane for adrenal carcinoma.
- Radiotherapy within 3 weeks prior to the first dose of study drug. Palliative radiotherapy will be allowed
- Intake of strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil (withdrawn in the US), nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin and voriconazole) and strong CYP3A4 inducers (e.g., carbamazepine, phenytoin , rifampin and St. John's Wort)
Trial locations and contacts
1 site in 1 country.
Hungary1 site
PRA Magyarorszag Kft. Fazis I-es Klin.Farmakol. Vizsgalohely
Budapest, 1077
About this study
Official title: A Phase I, Single Center, Open-label, Non-randomized, Non-placebo-controlled Study to Investigate the Metabolism, Excretion Pattern, Mass Balance, Safety, Tolerability and Pharmacokinetics of Orally Administered [14C]-Roniciclib (BAY 1000394) in Patients With Solid Tumors
The purpose of this trial is to investigate the fate of the roniciclib (study drug) in the body in a so called mass-balance study. This means to investigate how the study drug is absorbed, distributed, broken down (metabolized) and removed (excreted or eliminated) from the body.
- Conditions
- Neoplasms
- Being tested
- roniciclib (BAY 1000394)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
roniciclib (BAY 1000394)Drug
Single dose , 2.5 mg roniciclib spiked with 5.0 MBq of [14C] roniciclib solution
roniciclib (BAY 1000394)Drug
5 mg roniciclib tablet , Multiple dose, twice a day (bid), on a 3-days on/4-days off regimen in cycles of 21 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Open label non-randomized non-controlled mass balance study in Cycle 1 Receives: Drug: roniciclib (BAY 1000394) |
| Arm 2 | Experimental | Open label non-randomized non controlled multiple dose study in Cycle 2 and subsequent cycles Receives: Drug: roniciclib (BAY 1000394) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Roniciclib in urine as percentage of the dose of total radioactivity.
Measured: Up to 336 hours
Amount of Roniciclib in feces as percentage of the dose of total radioactivity.
Measured: Up to 336 hours
Amount of Roniciclib in vomit as percentage of the dose of total radioactivity
Measured: Up to 336 hours
Cmaxof roniciclib in plasma
Measured: up to 336 hours
AUC(0-tlast) of roniciclib in plasma
Measured: up to 336 hours
AUC of roniciclib in plasma
Measured: up to 336 hours
Cmax of total radioactivity in whole blood and plasma
Measured: up to 336 hours
AUC(0-tlast) of total radioactivity in whole blood and plasma
Measured: Up to 336 hours
AUC of total radioactivity in whole blood and plasma
Measured: up to 336 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390154
- Sponsor's protocol ID
- 15022
- Other IDs
- 2014-002797-37, 2014
- Status last verified
- Jul 2016
- First submitted
- 11 Mar 2015
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Center, Open-label, Non-randomized, Non-placebo-controlled Study to Investigate the Metabolism, Excretion Pattern, Mass Balance, Safety, Tolerability and Pharmacokinetics of Orally Administered [14C]-Roniciclib (BAY 1000394) in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT02390154
- Acronym / sponsor ID
- 15022
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Mar 2015 (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 purpose of this trial is to investigate the fate of the roniciclib (study drug) in the body in a so called mass-balance study. This means to investigate how the study drug is absorbed, distributed, broken down (metabolized) and removed (excreted or eliminated) from the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: roniciclib (BAY 1000394)Open label non-randomized non-controlled mass balance study in Cycle 1 |
| Arm 2 | Experimental | Drug: roniciclib (BAY 1000394)Open label non-randomized non controlled multiple dose study in Cycle 2 and subsequent cycles |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - Male or female subjects aged ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Subjects with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable
- Adequate bone marrow, liver, and renal functions as assessed by laboratory requirements to be conducted within 14 days prior to the first dose of study drug:
Key exclusion criteria (5 listed)
- Previous deep vein thrombosis (within the last 6 months), arterial thrombotic events (including strokes), or pulmonary embolism
- History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class III or IV, angina (within past 6 months prior to study entry), myocardial infarction, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- Anticancer chemotherapy or immunotherapy within 4 weeks of study entry. Mitomycin C or nitrosoureas should not be given within 6 weeks of study entry. Accepted exemptions are bisphosphonates, luteinising hormone releasing hormone (LHRH) agonists for prostate cancer, and mitotane for adrenal carcinoma.
- Radiotherapy within 3 weeks prior to the first dose of study drug. Palliative radiotherapy will be allowed
- Intake of strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil (withdrawn in the US), nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin and voriconazole) and strong CYP3A4 inducers (e.g., carbamazepine, phenytoin , rifampin and St. John's Wort)
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 |
|---|---|---|
| roniciclib (BAY 1000394)Single dose , 2.5 mg roniciclib spiked with 5.0 MBq of [14C] roniciclib solution | Drug | Arm 1 |
| roniciclib (BAY 1000394)5 mg roniciclib tablet , Multiple dose, twice a day (bid), on a 3-days on/4-days off regimen in cycles of 21 days | Drug | Arm 2 |
Primary outcome
Amount of Roniciclib in urine as percentage of the dose of total radioactivity.
Time frame: Up to 336 hours
Amount of Roniciclib in feces as percentage of the dose of total radioactivity.
Time frame: Up to 336 hours
Amount of Roniciclib in vomit as percentage of the dose of total radioactivity
Time frame: Up to 336 hours
Cmaxof roniciclib in plasma
Time frame: up to 336 hours
AUC(0-tlast) of roniciclib in plasma
Time frame: up to 336 hours
AUC of roniciclib in plasma
Time frame: up to 336 hours
Cmax of total radioactivity in whole blood and plasma
Time frame: up to 336 hours
AUC(0-tlast) of total radioactivity in whole blood and plasma
Time frame: Up to 336 hours
AUC of total radioactivity in whole blood and plasma
Time frame: up to 336 hours
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 15 Jul 2016.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing roniciclib (BAY 1000394) in people with Neoplasms, run by Bayer at 1 site in Hungary.
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 4 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: finished, as of the sponsor's last update on 15 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. 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?
Amount of Roniciclib in urine as percentage of the dose of total radioactivity. (time frame: Up to 336 hours). The study lists 9 primary outcomes in all. 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 15 Jul 2016.