Hematologic NeoplasmsPhase 1NCT02745743
Phase I Trial of BAY1251152 for Advanced Blood Cancers
A Phase 1 study testing BAY1251152 in people with Hematologic Neoplasms, run by Bayer at 6 sites in 4 countries.
Trial summary
The purpose of this study is to identify the most appropriate dose that can be safely administered and that can have an effect on blood cancer cells. Once that safe dose is identified, additional patients will be asked to join the study to further evaluate the safety and effectiveness of the study drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Neoplasms
- What is being tested?
- BAY1251152
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 17 Jun 2016to 3 Aug 2018
- 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 patients aged ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and Life expectancy of at least 12 weeks
- Patients are able and willing to provide bone marrow biopsies/aspirates as requested by the protocol
- Patients with confirmed advanced hematological malignancies
- Negative serum pregnancy test
- Women and men of reproductive potential must agree to use highly effective contraception when sexually active.
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- Ability to understand and the willingness to sign a written informed consent.
- Patients must have adequate coagulation (international normalized ratio (INR) or prothrombin time (PT), partial thromboplastin time (PTT) ≤1.5 times ULN)
- Adequate liver function (total bilirubin ≤ 1.5 times the ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN
Who cannot join
- Presence of active/uncontrolled central nervous system involvement
- History of clinically significant cardiac disease; uncontrolled hypertension
- Left ventricular ejection fraction (LVEF) < 45%
- Allogeneic stem cell transplant within 100 days before first dose of study drug
- Known history of human immunodeficiency virus (HIV) infection
- Chronic or active hepatitis B or C, requiring antiviral therapy
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- Evidence of history of bleeding disorder, dialysis, or coexisting cancer that is distinct in primary site or histology from the cancer evaluated in this study
- Serious, uncontrolled infection
- Unresolved chronic toxicity > grade 1 from prior therapy
- Use of strong CYP3A4 inhibitors or strong inducers within 7 days prior to the start of study treatment and for the duration of the study
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United States3 sites
Study site
Nashville, Tennessee, 37232
Study site
New York, New York, 10032
Study site
The Bronx, New York, 10461
About this study
Official title: An Open-label, Multicenter Phase I Study to Characterize the Safety, Tolerability, Preliminary Anti-tumor Activity, Pharmacokinetics and Maximum Tolerated Dose of BAY1251152 in Patients With Advanced Hematological Malignancies
The purpose of this study is to identify the most appropriate dose that can be safely administered and that can have an effect on blood cancer cells. Once that safe dose is identified, additional patients will be asked to join the study to further evaluate the safety and effectiveness of the study drug. The study will also investigate the pharmacokinetics (study of what the body does to the drug), as well as pharmacodynamics (study of what the drug does to the body), which may provide information about the effects of BAY 1251152. The study will also measure some biological markers (markers of biological activity in your body) that can be used to predict the response and safety of the proposed treatment.
- Conditions
- Hematologic Neoplasms
- Being tested
- BAY1251152
- Keywords
- Phase 1, Dose escalation, Dose expansion, Positive transcription elongation factor b inhibitor, Cyclin-dependent kinase 9 inhibitor
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1251152Drug
Weekly infusion of BAY1251152 in 21-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Biomarker-enriched advanced hematological neoplasms Receives: Drug: BAY1251152 |
| Arm 2 | Experimental | Other selected advanced hematological neoplasms Receives: Drug: BAY1251152 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose(MTD)
To determine the MTD of BAY1251152 in subjects with advanced hematological neoplasms
Measured: 21 days
Recommended Phase 2 dose (RP2D)
To determine the RP2D of BAY1251152 based on safety, tolerability, pharmacokinetic, and pharmacodynamic data in subjects with advanced hematological neoplasms
Measured: Up to 30 months
Number of adverse events (AE)
For assessment of the safety (ECG, vital signs, clinical significant abnormal laboratory results… etc.)and tolerability of BAY 1251152 in subjects with advanced hematological neoplasms
Measured: Up to 30 months
Pharmacokinetics (PK) is determined by maximum concentration (Cmax)
Measured: 21 days
Pharmacokinetics (PK) is determined by Area Under concentration versus time Curve (AUC)
Measured: 21 days
Secondary outcomes (1)
Response assessment of BAY 1251152 in hematological malignancies based on the internationally accepted criteria for the specific hematological malignancy which patient is suffering from
To assess the clinical efficacy of BAY 1251152 in subjects with advanced hematological neoplasms
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study start17 Jun 2016
- Primary completion3 Aug 2018
- Study completion3 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic 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
- 21 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
- NCT02745743
- Sponsor's protocol ID
- 18117
- Other IDs
- 2015-005122-18, 2015
- Status last verified
- Sep 2019
- First submitted
- 18 Apr 2016
- Last updated
- 19 Sep 2019
- 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 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase I Study to Characterize the Safety, Tolerability, Preliminary Anti-tumor Activity, Pharmacokinetics and Maximum Tolerated Dose of BAY1251152 in Patients With Advanced Hematological Malignancies
- ClinicalTrials.gov ID
- NCT02745743
- Acronym / sponsor ID
- 18117
- Conditions
- Hematologic Neoplasms
- Keywords
- Phase 1, Dose escalation, Dose expansion, Positive transcription elongation factor b inhibitor, Cyclin-dependent kinase 9 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2016 (actual)
- Primary completion
- 3 Aug 2018 (actual)
- Study completion
- 3 Aug 2018 (actual)
- First posted
- 20 Apr 2016 (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 identify the most appropriate dose that can be safely administered and that can have an effect on blood cancer cells. Once that safe dose is identified, additional patients will be asked to join the study to further evaluate the safety and effectiveness of the study drug. The study will also investigate the pharmacokinetics (study of what the body does to the drug), as well as pharmacodynamics (study of what the drug does to the body), which may provide information about the effects of BAY 1251152. The study will also measure some biological markers (markers of biological activity in your body) that can be used to predict the response and safety of the proposed treatment.
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: BAY1251152Biomarker-enriched advanced hematological neoplasms |
| Arm 2 | Experimental | Drug: BAY1251152Other selected advanced hematological neoplasms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female patients aged ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and Life expectancy of at least 12 weeks
- Patients are able and willing to provide bone marrow biopsies/aspirates as requested by the protocol
- Patients with confirmed advanced hematological malignancies
- Negative serum pregnancy test
Key exclusion criteria (10 listed)
- Presence of active/uncontrolled central nervous system involvement
- History of clinically significant cardiac disease; uncontrolled hypertension
- Left ventricular ejection fraction (LVEF) < 45%
- Allogeneic stem cell transplant within 100 days before first dose of study drug
- Known history of human immunodeficiency virus (HIV) infection
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 |
|---|---|---|
| BAY1251152Weekly infusion of BAY1251152 in 21-day cycles. | Drug | Arm 1, Arm 2 |
Primary outcome
Maximum tolerated dose(MTD)
Time frame: 21 days
To determine the MTD of BAY1251152 in subjects with advanced hematological neoplasms
Recommended Phase 2 dose (RP2D)
Time frame: Up to 30 months
To determine the RP2D of BAY1251152 based on safety, tolerability, pharmacokinetic, and pharmacodynamic data in subjects with advanced hematological neoplasms
Number of adverse events (AE)
Time frame: Up to 30 months
For assessment of the safety (ECG, vital signs, clinical significant abnormal laboratory results… etc.)and tolerability of BAY 1251152 in subjects with advanced hematological neoplasms
Pharmacokinetics (PK) is determined by maximum concentration (Cmax)
Time frame: 21 days
Pharmacokinetics (PK) is determined by Area Under concentration versus time Curve (AUC)
Time frame: 21 days
1 secondary outcome
Response assessment of BAY 1251152 in hematological malignancies based on the internationally accepted criteria for the specific hematological malignancy which patient is suffering from
Time frame: Up to 30 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 19 Sep 2019.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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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
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY1251152 in people with Hematologic Neoplasms, run by Bayer at 6 sites in 4 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 9 inclusion and 10 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 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Germany, Spain, United Kingdom. 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?
Maximum tolerated dose(MTD) (time frame: 21 days). 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 19 Sep 2019.