NeoplasmsPhase 1NCT02369029
BAY1238097, First in Man
A Phase 1 study testing BAY 1238097 in people with Neoplasms, run by Bayer at 6 sites in 6 countries.
Trial summary
This is the first study where BAY1238097 is given to humans. Impact of the study is to evaluate if patients with advanced cancer show clinical benefit under the treatment with BET(Bromodomain and extraterminal domain family ) inhibitor.Patients with solid tumors (all comers) and lymphoma will receive the study drug… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- BAY 1238097
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Mar 2015to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with advanced, histologically or cytologically confirmed tumor, refractory to any standard treatment, with no standard therapy available, in whom standard therapy is not a therapeutic option or the subject actively refuses use of chemotherapy which would be regarded standard and/or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy of at least 12 weeks
- Adequate liver and renal functions as assessed by the following laboratory requirements to be conducted within 7 days prior to starting study treatment:
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with hepatic involvement with tumor)
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- Amylase and lipase ≤ 2.5 x ULN (≤ 5 x ULN for subjects with pancreas involvement with tumor)
- Prothrombin time (PT-INR)/ partial thromboplastin time (PTT) ≤ 1.5 x ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement that is pre dose as defined by the local standard of care
- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min per 1.73 m2 according to the Modification of Diet in Renal Disease Study Group (MDRD) formula (see Section 14.6)
- Adequate cardiac function (left ventricular ejection fraction [LVEF] ≥50% measured by echocardiography or multi-gated acquisition [MUGA] scan)
Who cannot join
- History of cardiac disease including congestive heart failure New York Heart Association (NYHA) Class >II (Section 14.7), unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months) or myocardial infarction within the past 6 months and cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin; evidence for uncontrolled coronary artery disease (eg angina pectoris, myocardial infarction within 6 months prior to study entry, major regional wall motion abnormalities upon baseline echocardiography)
- Moderate and severe hepatic impairment, ie Child-Pugh B or C
- Restrictive lung diseases due to parenchymal damage (eg idiopathic lung fibrosis) or pleural adhesions. Patients with lung resection, scoliosis or thorax malformations can be included provided adequate spirometry testing during screening (eg FEV-Forced expiratory volume 1 ≥ 70%; age, sex and height adapted vital capacity)
- Evidence or history of bleeding diathesis. Any hemorrhage/bleeding event ≥ CTCAE (Common terminology criteria for adverse events) Grade 3 within 4 weeks of first dose of study drug
- Human immunodeficiency virus (HIV) infection
- Chronic or active hepatitis B or C (patients positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; patients positive for HCVAb will be eligible if negative for HCV-RNA)
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- History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with a history of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix or breast are allowed. Patients with a malignancy that has been treated with curative intent will also be allowed if the malignancy has been in complete remission without treatment for at least 1 year prior to Cycle 1 Day 1 of study treatment. A recent history of myelodysplastic syndrome in patients with secondary leukemia is allowed
- Autologous bone marrow transplant or stem cell rescue within 4 months of study entry
- Any condition that is unstable or could jeopardize the safety of the patient and his/her compliance in the study
- Anticancer chemotherapy or immunotherapy during the study or within less than 3 half-lives for anticancer chemotherapy or 6 weeks for antibody therapies (2 weeks for leukemia patients) prior to start of study drug.
- Use of any strong CYP3A4 inhibitor such as ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir, or saquinavir (see Table 6 6) 14 days before the first dose of study drug or during the study
- Use of any strong CYP3A4 inducer such as rifampin, St John's Wort, or other herbal preparations that contain any strong CYP3A4 inducer (see Table 6 6) 14 days before the first dose of study drug or during the study
- Clinically relevant findings in the ECG such as a second-degree or third-degree atrioventricular (AV) block (subjects with AV block and pacemaker in place for >1 year and checked by a cardiologist within ≤6 months before the first dose of study drug will not be excluded), prolongation of the QRS complex over 120 msec or of the QTc interval (Fridericia, QTcF) over 470 msec (subjects with a pacemaker and QRS interval over 120 msec or QTc inverval over 470 msec may be enrolled on a case-by-case basis, following a discussion between the investigator and the sponsor).
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: An Open-label, Non-randomized, Multicenter Phase I Dose Escalation Study to Characterize Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY 1238097 in Subjects With Advanced Malignancies
This is the first study where BAY1238097 is given to humans. Impact of the study is to evaluate if patients with advanced cancer show clinical benefit under the treatment with BET(Bromodomain and extraterminal domain family ) inhibitor.Patients with solid tumors (all comers) and lymphoma will receive the study drug treatment in an escalation scheme (no placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY1238097. the relative bioavailability of Liquid Service Formulation and tablets will be determined
After MTD is defined, patients with solid tumors (all comer, hepato cellular carcinoma, lung cancer, NUT(nuclear protein in testis)-midline carcinoma), melanoma and lymphoma will be enrolled A separate escalation scheme will be applied to patients with leucemias, and at the maximal tolerated dose, patients with AML amd multiple myeloma will be enrolled.
Read more
the study will also assess the pharmacokinetics, biomarker status, pharmacodynamic parameters of BAY1238097 and tumor response to the treatment.
BAY1238097 will be given twice weekly as oral application. Treatment will be stopped if the tumor continues to grow, if side effects occur, wich the patient cannot tolerate or if the patient decides to withdraw from the treatment.
- Conditions
- Neoplasms
- Being tested
- BAY 1238097
- Keywords
- Phase I, Dose escalation, NUT-midline carcinoma, Acute Leucemia, Lymphoma, Melanoma, Myeloma, HCC, NSCLC
- Medical subject headings
- Neoplasms, Lymphoma, Melanoma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY 1238097Drug
Oral administration twice weekly. Starting dose will be 10 mg per week and dose will be escalated dependent on any dose limiting toxicities.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | To determine maximum tolerated dose (MTD) of BAY 1238097 Receives: Drug: BAY 1238097 |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of DLT(dose-limiting toxicities)
Measured: Cycle 1(the first 21 days )
Secondary outcomes (1)
Tumor response evaluation based on the response criteria as applicable
Measured: up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionJan 2016
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 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
- 8 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
- NCT02369029
- Sponsor's protocol ID
- 17437
- Other IDs
- 2014-003131-19, 2014
- Status last verified
- Mar 2016
- First submitted
- 17 Feb 2015
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Postel-Vinay S, Herbschleb K, Massard C, Woodcock V, Soria JC, Walter AO, Ewerton F, Poelman M, Benson N, Ocker M, Wilkinson G, Middleton M. First-in-human phase I study of the bromodomain and extraterminal motif inhibitor BAY 1238097: emerging pharmacokinetic/pharmacodynamic relationship and early termination due to unexpected toxicity. Eur J Cancer. 2019 Mar;109:103-110. doi: 10.1016/j.ejca.2018.12.020. Epub 2019 Jan 31.
PubMed 30711772
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-randomized, Multicenter Phase I Dose Escalation Study to Characterize Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY 1238097 in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT02369029
- Acronym / sponsor ID
- 17437
- Conditions
- Neoplasms
- Keywords
- Phase I, Dose escalation, NUT-midline carcinoma, Acute Leucemia, Lymphoma, Melanoma, Myeloma, HCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 23 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.
This is the first study where BAY1238097 is given to humans. Impact of the study is to evaluate if patients with advanced cancer show clinical benefit under the treatment with BET(Bromodomain and extraterminal domain family ) inhibitor.Patients with solid tumors (all comers) and lymphoma will receive the study drug treatment in an escalation scheme (no placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY1238097. the relative bioavailability of Liquid Service Formulation and tablets will be determined
After MTD is defined, patients with solid tumors (all comer, hepato cellular carcinoma, lung cancer, NUT(nuclear protein in testis)-midline carcinoma), melanoma and lymphoma will be enrolled A separate escalation scheme will be applied to patients with leucemias, and at the maximal tolerated dose, patients with AML amd multiple myeloma will be enrolled.
the study will also assess the pharmacokinetics, biomarker status, pharmacodynamic parameters of BAY1238097 and tumor response to the treatment.
BAY1238097 will be given twice weekly as oral application. Treatment will be stopped if the tumor continues to grow, if side effects occur, wich the patient cannot tolerate or if the patient decides to withdraw from the treatment.
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: BAY 1238097To determine maximum tolerated dose (MTD) of BAY 1238097 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects with advanced, histologically or cytologically confirmed tumor, refractory to any standard treatment, with no standard therapy available, in whom standard therapy is not a therapeutic option or the subject actively refuses use of chemotherapy which would be regarded standard and/or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy of at least 12 weeks
- Adequate liver and renal functions as assessed by the following laboratory requirements to be conducted within 7 days prior to starting study treatment:
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
Key exclusion criteria (13 listed)
- History of cardiac disease including congestive heart failure New York Heart Association (NYHA) Class >II (Section 14.7), unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months) or myocardial infarction within the past 6 months and cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin; evidence for uncontrolled coronary artery disease (eg angina pectoris, myocardial infarction within 6 months prior to study entry, major regional wall motion abnormalities upon baseline echocardiography)
- Moderate and severe hepatic impairment, ie Child-Pugh B or C
- Restrictive lung diseases due to parenchymal damage (eg idiopathic lung fibrosis) or pleural adhesions. Patients with lung resection, scoliosis or thorax malformations can be included provided adequate spirometry testing during screening (eg FEV-Forced expiratory volume 1 ≥ 70%; age, sex and height adapted vital capacity)
- Evidence or history of bleeding diathesis. Any hemorrhage/bleeding event ≥ CTCAE (Common terminology criteria for adverse events) Grade 3 within 4 weeks of first dose of study drug
- 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 |
|---|---|---|
| BAY 1238097Oral administration twice weekly. Starting dose will be 10 mg per week and dose will be escalated dependent on any dose limiting toxicities. | Drug | Arm 1 |
Primary outcome
incidence of DLT(dose-limiting toxicities)
Time frame: Cycle 1(the first 21 days )
1 secondary outcome
Tumor response evaluation based on the response criteria as applicable
Time frame: up to 6 months.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
- Derived from this study: PubMed 30711772Postel-Vinay S, Herbschleb K, Massard C, Woodcock V, Soria JC, Walter AO, Ewerton F, Poelman M, Benson N, Ocker M, Wilkinson G, Middleton M. First-in-human phase I study of the bromodomain and extraterminal motif inhibitor BAY 1238097: emerging pharmacokinetic/pharmacodynamic relationship and early termination due to unexpected toxicity. Eur J Cancer. 2019 Mar;109:103-110. doi: 10.1016/j.ejca.2018.12.020. Epub 2019 Jan 31.
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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 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY 1238097 in people with Neoplasms, run by Bayer at 6 sites in 6 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 10 inclusion and 13 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: stopped early, as of the sponsor's last update on 9 Mar 2016. 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, Finland, France, Germany, Switzerland and 1 more country. 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 was stopped early. Results are not available in the source record.
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?
incidence of DLT(dose-limiting toxicities) (time frame: Cycle 1(the first 21 days )). 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 NCT02369029, 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 9 Mar 2016.