Medical OncologyPhase 1NCT02366949
Phase I Study of Oral BAY 1217389 in Combination With Intravenous Paclitaxel
A Phase 1 study testing BAY1217389 and Paclitaxel in people with Medical Oncology, run by Bayer at 7 sites in 2 countries.
Trial summary
Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral BAY1217389 given in combination with intravenous (IV) paclitaxel using an intermittent dosing schedule (2 days on / 5 days off) in subjects with advanced malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Oncology
- What is being tested?
- BAY1217389 and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 27 Feb 2015to 18 Apr 2019
- 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
- Male or female subjects aged >/= 18 years.
- Study population:
- For the dose-escalation cohorts: Subjects with histologically or cytologically confirmed advanced malignancies (solid tumors), refractory to any standard therapy, have no standard therapy available
- For the expansion cohort: Subjects with advanced, histologically or cytologically confirmed triple-negative breast cancer (TNBC), refractory to any standard therapy, have no standard therapy available, or subjects actively refused any standard treatment and / or if, in the judgment of the investigator, experimental treatment is clinically acceptable.
- Subjects must have evaluable or measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Life expectancy of at least 12 weeks.
- Adequate bone marrow, liver, and renal functions.
Who cannot join
- Known hypersensitivity to the study drugs or excipients of the preparations or any agent given in association with this study.
- Evidence of peripheral neuropathy of Grade >2.
- 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 before study entry), myocardial infarction within the past 3 months before study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers, calcium channel blockers, and digoxin are permitted).
- Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg, despite optimal medical management.
- Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C.
- History of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Study site
Denver, Colorado, 80262
Study site
Hackensack, New Jersey, 07601-1991
Study site
Houston, Texas, 77030
Study site
New Haven, Connecticut, 06520
Study site
San Antonio, Texas, 78229-3307
Study site
Santa Monica, California, 90403
About this study
Official title: An Open-label Randomized Two-arm Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of Oral BAY 1217389 in Combination With Weekly Intravenous Paclitaxel Given in an Intermittent Dosing Schedule in Subjects With Advanced Malignancies
Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral BAY1217389 given in combination with intravenous (IV) paclitaxel using an intermittent dosing schedule (2 days on / 5 days off) in subjects with advanced malignancies.
Read the detailed description
BAY1217389 is a potent and highly selective inhibitor of monopolar spindle 1 (MPS1) kinase activity. Human MPS1 is a serine threonine kinase, which functions as a core component of the spindle-assembly checkpoint (SAC), a key surveillance mechanism that monitors the attachment of spindle microtubules to the kinetochores of the chromosomes during pro-metaphase and halts the transitions to anaphase until all chromosomes are bi-oriented, fully attached, and correctly tensed at the metaphase plate. MPS1 is expressed in the mitosis phase of the cell cycle in proliferating cells. Overexpression of MPS1 has been observed in several cancer cell lines and tumor types, including lung and breast cancers.
Established anti-mitotic drugs such as vinca alkaloids, taxanes, or epothilones activate the SAC either by destabilizing or stabilizing spindle microtubules resulting in mitotic arrest. Prolonged arrest in mitosis forces a cell either into a mitotic exit without cytokinesis or into a mitotic catastrophe leading to cell death. In contrast, MPS1 inhibitors inactivate the SAC and accelerate progression of cells through mitosis eventually resulting in severe chromosomal missegregation, mitotic catastrophe, and cell death. Consequently, MPS1 inhibition leads to failure of cells to arrest in mitosis in response to anti-mitotic drugs. Thus, the combination of microtubule-interfering agents and MPS1 inhibition strongly increases chromosomal segregation errors and cell death and therefore, constitutes an efficient strategy for selectively eliminating tumor cells.
MPS1 inhibition in combination with microtubule-interfering agents is expected to improve therapeutic efficacy of anti-mitotic drugs and to overcome paclitaxel resistance.
The primary objectives of this study are to:
- Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral BAY1217389 given in combination with intravenous (IV) paclitaxel using an intermittent dosing schedule (2 days on / 5 days off) in subjects with advanced malignancies.
- Characterize the pharmacokinetics (PK) of oral BAY1217389 and IV paclitaxel.
The exploratory objectives of this study are to:
- Determine any preliminary clinical efficacy of oral BAY1217389 given in combination with IV paclitaxel compared to paclitaxel given alone.
- Determine pharmacodynamic (PD) target modulation effects (decrease in phosphorylated kinetochore-associated protein pKNL1 and potentially other biomarkers like activation of the p53 system) of oral BAY1217389 in mandatory paired fresh tumor biopsies (or in mandatory paired fresh skin punch biopsies depending on the status of the subject and the accessibility of the tumor) taken on Day 2 of Cycle 1 (C1D2) and on C1D3.
- Evaluate the effect of oral BAY1217389 on the activation of p53 in blood samples as PD biomarker (blood samples will be taken as a mandatory procedure to monitor PD effects on C1D 4, C1D 3, and C1D 2).
- Evaluate the effect of BAY1217389 on levels of tumor-derived free circulating deoxyribonucleic acid (DNA) in blood samples taken before the first dose of study treatment and on C1D3, C1D8, and C1D15
- Conditions
- Medical Oncology
- Being tested
- BAY1217389, Paclitaxel
- Keywords
- Phase 1, Solid tumors, Breast cancer, Paclitaxel, MPS-1 inhibitor, Oncology
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1217389Drug
BAY1217389 will be given orally, with a starting dose of 0.25 mg twice daily, on D1, D2, D8, D9, D15 and D16 of a 28 day cycle. BAY1217389 will be dosed in combination with paclitaxel in Arm 1 (Experimental Treatment) and from Cycle 2 onwards in Arm 2 (Standard Treatment).
After Maximum tolerated dose (MTD) has been defined, expansion cohorts will be conducted at the MTD dose of BAY1217389 and paclitaxel following an intermittent dosing schedule as defined in the dose escalation phase. Up to 12 to 15 breast cancer (triple negative) subjects are planned to be enrolled in the expansion cohort.
In a higher dose level Cohort 4 > (or equal to) a relative bioavailability assessment of BAY1217389 liquid capsule formulation compared to BAY1217389 oral solution will be performed.
PaclitaxelDrug
Paclitaxel will be given once per week IV at 90 mg/m^2 on D1, D8, and D15 of a 28 day cycle. Paclitaxel will be dosed as a single-agent in Cycle 1 of Arm 2 (Standard Treatment Arm), and in combination with BAY1217389 in Arm 1 (Experimental Treatment Arm) and from Cycle 2 onwards in Arm 2 (Standard Treatment Arm). After Maximum tolerated dose (MTD) has been defined, expansion cohorts will be conducted at the MTD dose of BAY1217389 and paclitaxel following an intermittent dosing schedule as defined in the dose escalation phase. Up to 12 to 15 breast cancer (triple negative) subjects are planned to be enrolled in the expansion cohort.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Experimental Treatment (combination of BAY1217389 with paclitaxel in an intermittent dosing schedule) Expansion Cohort - Maximum tolerated dose of BAY1217389 and Paclitaxel Receives: Drug: BAY1217389; Drug: Paclitaxel |
| Arm 2 | Placebo comparator | Standard Treatment (Single-agent Paclitaxel ) Receives: Drug: BAY1217389; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
The MTD is defined as the highest dose that can be given such that the dose-limiting toxicity (DLT) rate of the combination treatment is not more than 10% higher than the cumulative DLT rate of the standard single-agent treatment across all previous and the current cohort.
Measured: Up to 28 days (Cycle 1)
Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability.
Measured: After the first study drug administration and up to 30 days after the end of treatment with study drug before primary completion analysis of the study, up to 3 years
Maximum observed drug concentration (Cmax) of BAY1217389 in plasma
Measured: From pre-dose up to 96 hours post-dose on C1D-8 and C1D-4; from pre-dose up to 12 hours post-dose on C1D8 and C1D9
Area under the concentration versus time curve from zero to 12 hours (AUC [0-12]) of BAY1217389 in plasma
Measured: From pre-dose up to 12 hours post-dose on C1D-4, C1D8 and C1D9
Area under the concentration versus time curve from zero to 96 hours (AUC [0-96]) of BAY1217389 in plasma
Measured: From pre-dose up to 96 hours post-dose on C1D-4
Maximum observed drug concentration (Cmax) of paclitaxel in plasma
Measured: From pre-dose up to 24 hours post-dose on C1D1 and C1D8
Area under the concentration versus time curve from zero to infinity (AUC) of paclitaxel in plasma
Measured: From pre-dose up to 24 hours post-dose on C1D1 and C1D8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study start27 Feb 2015
- Primary completion30 Mar 2018
- Study completion18 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical OncologyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 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
- NCT02366949
- Sponsor's protocol ID
- 17350
- Other IDs
- 2014-004821-41, 2014
- Status last verified
- Apr 2020
- First submitted
- 12 Feb 2015
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Randomized Two-arm Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of Oral BAY 1217389 in Combination With Weekly Intravenous Paclitaxel Given in an Intermittent Dosing Schedule in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT02366949
- Acronym / sponsor ID
- 17350
- Conditions
- Medical Oncology
- Keywords
- Phase 1, Solid tumors, Breast cancer, Paclitaxel, MPS-1 inhibitor, Oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2015 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 18 Apr 2019 (actual)
- First posted
- 19 Feb 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.
Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral BAY1217389 given in combination with intravenous (IV) paclitaxel using an intermittent dosing schedule (2 days on / 5 days off) in subjects with advanced malignancies.
Detailed description
BAY1217389 is a potent and highly selective inhibitor of monopolar spindle 1 (MPS1) kinase activity. Human MPS1 is a serine threonine kinase, which functions as a core component of the spindle-assembly checkpoint (SAC), a key surveillance mechanism that monitors the attachment of spindle microtubules to the kinetochores of the chromosomes during pro-metaphase and halts the transitions to anaphase until all chromosomes are bi-oriented, fully attached, and correctly tensed at the metaphase plate. MPS1 is expressed in the mitosis phase of the cell cycle in proliferating cells. Overexpression of MPS1 has been observed in several cancer cell lines and tumor types, including lung and breast cancers.
Established anti-mitotic drugs such as vinca alkaloids, taxanes, or epothilones activate the SAC either by destabilizing or stabilizing spindle microtubules resulting in mitotic arrest. Prolonged arrest in mitosis forces a cell either into a mitotic exit without cytokinesis or into a mitotic catastrophe leading to cell death. In contrast, MPS1 inhibitors inactivate the SAC and accelerate progression of cells through mitosis eventually resulting in severe chromosomal missegregation, mitotic catastrophe, and cell death. Consequently, MPS1 inhibition leads to failure of cells to arrest in mitosis in response to anti-mitotic drugs. Thus, the combination of microtubule-interfering agents and MPS1 inhibition strongly increases chromosomal segregation errors and cell death and therefore, constitutes an efficient strategy for selectively eliminating tumor cells.
MPS1 inhibition in combination with microtubule-interfering agents is expected to improve therapeutic efficacy of anti-mitotic drugs and to overcome paclitaxel resistance.
The primary objectives of this study are to:
- Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral BAY1217389 given in combination with intravenous (IV) paclitaxel using an intermittent dosing schedule (2 days on / 5 days off) in subjects with advanced malignancies.
- Characterize the pharmacokinetics (PK) of oral BAY1217389 and IV paclitaxel.
The exploratory objectives of this study are to:
- Determine any preliminary clinical efficacy of oral BAY1217389 given in combination with IV paclitaxel compared to paclitaxel given alone.
- Determine pharmacodynamic (PD) target modulation effects (decrease in phosphorylated kinetochore-associated protein pKNL1 and potentially other biomarkers like activation of the p53 system) of oral BAY1217389 in mandatory paired fresh tumor biopsies (or in mandatory paired fresh skin punch biopsies depending on the status of the subject and the accessibility of the tumor) taken on Day 2 of Cycle 1 (C1D2) and on C1D3.
- Evaluate the effect of oral BAY1217389 on the activation of p53 in blood samples as PD biomarker (blood samples will be taken as a mandatory procedure to monitor PD effects on C1D 4, C1D 3, and C1D 2).
- Evaluate the effect of BAY1217389 on levels of tumor-derived free circulating deoxyribonucleic acid (DNA) in blood samples taken before the first dose of study treatment and on C1D3, C1D8, and C1D15
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BAY1217389, Drug: PaclitaxelExperimental Treatment (combination of BAY1217389 with paclitaxel in an intermittent dosing schedule) Expansion Cohort - Maximum tolerated dose of BAY1217389 and Paclitaxel |
| Arm 2 | Placebo comparator | Drug: BAY1217389, Drug: PaclitaxelStandard Treatment (Single-agent Paclitaxel ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects aged >/= 18 years.
- Study population:
- Subjects must have evaluable or measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Life expectancy of at least 12 weeks.
Key exclusion criteria (6 listed)
- Known hypersensitivity to the study drugs or excipients of the preparations or any agent given in association with this study.
- Evidence of peripheral neuropathy of Grade >2.
- 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 before study entry), myocardial infarction within the past 3 months before study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers, calcium channel blockers, and digoxin are permitted).
- Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg, despite optimal medical management.
- Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C.
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 |
|---|---|---|
| BAY1217389BAY1217389 will be given orally, with a starting dose of 0.25 mg twice daily, on D1, D2, D8, D9, D15 and D16 of a 28 day cycle. BAY1217389 will be dosed in combination with paclitaxel in Arm 1 (Experimental Treatment) and from Cycle 2 onwards in Arm 2 (Standard Treatment). After Maximum tolerated dose (MTD) has been defined, expansion cohorts will be conducted at the MTD dose of BAY1217389 and paclitaxel following an intermittent dosing schedule as defined in the dose escalation phase. Up to 12 to 15 breast cancer (triple negative) subjects are planned to be enrolled in the expansion cohort. In a higher dose level Cohort 4 > (or equal to) a relative bioavailability assessment of BAY1217389 liquid capsule formulation compared to BAY1217389 oral solution will be performed. | Drug | Arm 1, Arm 2 |
| PaclitaxelPaclitaxel will be given once per week IV at 90 mg/m^2 on D1, D8, and D15 of a 28 day cycle. Paclitaxel will be dosed as a single-agent in Cycle 1 of Arm 2 (Standard Treatment Arm), and in combination with BAY1217389 in Arm 1 (Experimental Treatment Arm) and from Cycle 2 onwards in Arm 2 (Standard Treatment Arm). After Maximum tolerated dose (MTD) has been defined, expansion cohorts will be conducted at the MTD dose of BAY1217389 and paclitaxel following an intermittent dosing schedule as defined in the dose escalation phase. Up to 12 to 15 breast cancer (triple negative) subjects are planned to be enrolled in the expansion cohort. | Drug | Arm 1, Arm 2 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Up to 28 days (Cycle 1)
The MTD is defined as the highest dose that can be given such that the dose-limiting toxicity (DLT) rate of the combination treatment is not more than 10% higher than the cumulative DLT rate of the standard single-agent treatment across all previous and the current cohort.
Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability.
Time frame: After the first study drug administration and up to 30 days after the end of treatment with study drug before primary completion analysis of the study, up to 3 years
Maximum observed drug concentration (Cmax) of BAY1217389 in plasma
Time frame: From pre-dose up to 96 hours post-dose on C1D-8 and C1D-4; from pre-dose up to 12 hours post-dose on C1D8 and C1D9
Area under the concentration versus time curve from zero to 12 hours (AUC [0-12]) of BAY1217389 in plasma
Time frame: From pre-dose up to 12 hours post-dose on C1D-4, C1D8 and C1D9
Area under the concentration versus time curve from zero to 96 hours (AUC [0-96]) of BAY1217389 in plasma
Time frame: From pre-dose up to 96 hours post-dose on C1D-4
Maximum observed drug concentration (Cmax) of paclitaxel in plasma
Time frame: From pre-dose up to 24 hours post-dose on C1D1 and C1D8
Area under the concentration versus time curve from zero to infinity (AUC) of paclitaxel in plasma
Time frame: From pre-dose up to 24 hours post-dose on C1D1 and C1D8
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 7 Apr 2020.
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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
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY1217389 and Paclitaxel in people with Medical Oncology, run by Bayer at 7 sites in 2 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 6 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 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Netherlands. 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. Some participants in this study may receive a placebo. 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?
Maximum tolerated dose (MTD) (time frame: Up to 28 days (Cycle 1)). The study lists 7 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 7 Apr 2020.