NeoplasmsPhase 1NCT01728311
Open Label Study of BAY1082439 in Patients With Advanced Cancer
A Phase 1 study testing BAY1082439 in people with Neoplasms, run by Bayer at 5 sites in 3 countries.
Trial summary
The purpose of this study is to determine the safety, tolerability and the pharmacokinetics of BAY1082439 Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- BAY1082439
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 21 Nov 2012to 6 Feb 2017
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Expansion phase only: Subjects with histologically or cytologically confirmed, locally advanced or metastatic endometrial cancer or breast cancer or iNHL, who are refractory to or have exhausted all available therapies
- International normalized ratio (INR) and partial thromboplastin time (PTT) <1.5 x ULN [Subjects on anticoagulation with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] For subjects on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre-dose, as defined by the local standard of care
- Measurable or evaluable disease
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate bone marrow, liver and renal function
Who cannot join
- History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) Class II, unstable angina (anginal symptoms at rest), new-onset angina (within the past 3 months prior to the first dose of study drug), myocardial infarction within the past 6 months prior to the first dose of study drug, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
- History of diabetes mellitus or gestational diabetes mellitus
- Fasting blood glucose level >125 mg/dL or HbA1c 7% at screening
- Active clinically serious infections > Grade 2
- History of organ allograft
- Seizure disorder requiring therapy (such as steroids or anti-epileptics)
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
About this study
Official title: An Open-label Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY 1082439 Given Once Daily Continuously or in an Intermittent Dosing Schedule in Subjects With Advanced Malignancies
The purpose of this study is to determine the safety, tolerability and the pharmacokinetics of BAY1082439
- Conditions
- Neoplasms
- Being tested
- BAY1082439
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1082439Drug
BAY1082439 will be given orally once daily with a 21 days cycle. Dose will be started from 15mg.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: BAY1082439 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability
Measured: Up to 2 years
Maximum tolerated dose of BAY1082439
Measured: Up to 1 year
Maximum observed plasma concentration (Cmax) of BAY1082439 after a single dose
Measured: Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2
Time to Cmax (tmax) of BAY1082439 after a single dose
Measured: Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2
Area under the plasma concentration-time curve (AUC[0-t]) of BAY1082439 after a single dose
Measured: Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2
Secondary outcomes (5)
Area under the concentration-time curve over the dosing interval (AUC[0-tau])
Measured: PK parameters following single and repeat-dose administration in cycle 1
Maximum observed concentration (Cmax)
Measured: PK parameters following single and repeat-dose administration in cycle 1
Time of occurrence of Cmax (tmax)
Measured: PK parameters following single and repeat-dose administration in cycle 1
Terminal phase half-life (t1/2)
Measured: PK parameters following single and repeat-dose administration in cycle 1
Tumor response based on Response Evaluation Criteria in Solid Tumors, Version 1.1
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2012 (estimated)
- Study start21 Nov 2012
- Primary completion3 Jun 2016
- Study completion6 Feb 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT01728311
- Sponsor's protocol ID
- 15734
- Status last verified
- Jan 2018
- First submitted
- 7 Nov 2012
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY 1082439 Given Once Daily Continuously or in an Intermittent Dosing Schedule in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT01728311
- Acronym / sponsor ID
- 15734
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2012 (actual)
- Primary completion
- 3 Jun 2016 (actual)
- Study completion
- 6 Feb 2017 (actual)
- First posted
- 19 Nov 2012 (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 study is to determine the safety, tolerability and the pharmacokinetics of BAY1082439
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BAY1082439 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- International normalized ratio (INR) and partial thromboplastin time (PTT) <1.5 x ULN [Subjects on anticoagulation with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] For subjects on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre-dose, as defined by the local standard of care
- Measurable or evaluable disease
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Key exclusion criteria (7 listed)
- History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) Class II, unstable angina (anginal symptoms at rest), new-onset angina (within the past 3 months prior to the first dose of study drug), myocardial infarction within the past 6 months prior to the first dose of study drug, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
- History of diabetes mellitus or gestational diabetes mellitus
- Fasting blood glucose level >125 mg/dL or HbA1c 7% at screening
- Active clinically serious infections > Grade 2
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 |
|---|---|---|
| BAY1082439BAY1082439 will be given orally once daily with a 21 days cycle. Dose will be started from 15mg. | Drug | Arm 1 |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 2 years
Maximum tolerated dose of BAY1082439
Time frame: Up to 1 year
Maximum observed plasma concentration (Cmax) of BAY1082439 after a single dose
Time frame: Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2
Time to Cmax (tmax) of BAY1082439 after a single dose
Time frame: Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2
Area under the plasma concentration-time curve (AUC[0-t]) of BAY1082439 after a single dose
Time frame: Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2
5 secondary outcomes
Area under the concentration-time curve over the dosing interval (AUC[0-tau])
Time frame: PK parameters following single and repeat-dose administration in cycle 1
Maximum observed concentration (Cmax)
Time frame: PK parameters following single and repeat-dose administration in cycle 1
Time of occurrence of Cmax (tmax)
Time frame: PK parameters following single and repeat-dose administration in cycle 1
Terminal phase half-life (t1/2)
Time frame: PK parameters following single and repeat-dose administration in cycle 1
Tumor response based on Response Evaluation Criteria in Solid Tumors, Version 1.1
Time frame: Up to 2 years
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 30 Jan 2018.
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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
5 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 BAY1082439 in people with Neoplasms, run by Bayer at 5 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 7 inclusion and 7 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 30 Jan 2018. 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 Singapore, South Korea, Taiwan. 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?
Number of participants with adverse events as a measure of safety and tolerability (time frame: Up to 2 years). 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?
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 30 Jan 2018.