NeoplasmsPhase 1NCT01297530
Clinical Study to Evaluate the Maximum Tolerated Dose of BAY87-2243 in Patients With Advanced Malignancies
A Phase 1 study testing BAY87-2243 in people with Neoplasms, run by Bayer at 3 sites in 3 countries.
Trial summary
This is the first study of this drug in human beings. Every patient will receive the drug, there is no placebo group. Patients with advanced tumors will be treated. Different groups of patients will receive different dosages to determine the safety and maximum tolerated dose (MTD) of BAY87-2243. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- BAY87-2243
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2011to Jul 2012
- 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
- 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 judgement of the investigator, experimental treatment is clinically and ethically acceptable
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Life expectancy of at least 3 month
- Adequate bone marrow, liver, and renal functions
Who cannot join
- History of cardiac disease including congestive heart failure > NYHA (New York Heart Association) II, unstable angina (anginal symptoms at rest), or new-onset angina (within the past 3 months) or myocardial infarction within the past 6 months and cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin
- History of ischemic cardiovascular disease
- Family history of long QT syndrome
- Persistent hypokalemia < 3.5 mmol/L
- History of cerebral ischemia including transient ischemic attack (TIA), prolonged reversible ischemic neurologic deficit (PRIND), and ischemic stroke within the past 6 months
- Known alcohol abuse
Show all 16Show fewer
- Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C
- Diabetes mellitus treated with oral antidiabetics or insulin
- History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
- Active clinically serious infections of CTCAE > Grade 2 (Common Terminology Criteria for Adverse Events v4.02)
- Symptomatic metastatic brain or meningeal tumors unless the subject is > 6 months from definitive therapy, has no evidence of tumor growth on an imaging study within 4 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry.
- Unresolved specific chronic toxicity CTCAE > Grade 2
- Subjects may not receive potent inducers of CYP3A4, such as phenytoin, carbamazepine, and rifampicin, as the oral clearance of ondansetron may increase and ondansetron plasma concentrations may decrease due to antiemetic regimen
- Concomitant medication with metformin
- Concomitant medication with drugs known to prolong the QT interval
- Relevant pathological changes in the ECG such as a second or third-degree AV block, prolongation of the QRS complex over 120 ms or of the QT / QTc-interval over 450 ms in men and women
Trial locations and contacts
3 sites in 3 countries.
3 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 BAY87-2243 Given Once Daily in Subjects With Advanced Malignancies
This is the first study of this drug in human beings. Every patient will receive the drug, there is no placebo group. Patients with advanced tumors will be treated. Different groups of patients will receive different dosages to determine the safety and maximum tolerated dose (MTD) of BAY87-2243. The study will also assess how the drug is metabolized by the body, its biologic effects in the body, and changes in tumor size.
BAY87-2243 will be given as a tablet which dissolves in the gut. Based on findings from this study it may be later given as a tablet which dissolves in the stomach.
Read more
BAY87-2243 will be given per mouth, once a day, every day. Treatment will stop if the tumor continues to grow, if side effects occur which the patient can not tolerate or if the patients decides to exit treatment.
The study will be conducted in 3 - 4 centers in 3 countries (Norway, United Kingdom and Germany). The study will have a part where doses are escalated in different groups of patients. Each dose level will be evaluated in a new group of 3 - 6 subjects. This will be followed by an extension part where patients are treated at the highest tolerable dose in groups of up to 25 patients. The extension part will be described in an amendment to the study protocol later. The number of subjects estimated for this study will depend on the number of groups enrolled. The starting dose will be 5 mg given orally as a tablet formulation.
- Conditions
- Neoplasms
- Being tested
- BAY87-2243
- Keywords
- Phase I, Dose Escalation, Hypoxia inducible factor 1 alpha, Neoplasms
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY87-2243Drug
Oral administration once daily in a continuous schedule. Starting dose will be 5 mg and dose will be escalated dependent on any dose limiting toxicities.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: BAY87-2243 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events
Measured: Up to 3 years or longer if indicated
Maximum tolerated dose, measured by adverse event profile
Measured: Up to 3 years or longer if indicated
Secondary outcomes (3)
Plasma concentrations of BAY87-2243, measured by Cmax, tmax, AUC(0-tn), AUC and half-life
Measured: Up to 3 years or longer if indicated
Biomarkers evaluation (analysis of carbonic anhydrase 9 and VEGF in plasma)
Measured: Up to 3 years or longer if indicated
Tumor response evaluation based on RECIST 1.1 every 2 cycles
Measured: Up to 3 years or longer if indicated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2012
- Study completionJul 2012
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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297530
- Sponsor's protocol ID
- 15044
- Other IDs
- 2010-023403-10
- Status last verified
- Jul 2013
- First submitted
- 15 Feb 2011
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. 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 BAY87-2243 Given Once Daily in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT01297530
- Acronym / sponsor ID
- 15044
- Conditions
- Neoplasms
- Keywords
- Phase I, Dose Escalation, Hypoxia inducible factor 1 alpha, Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 Feb 2011 (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 of this drug in human beings. Every patient will receive the drug, there is no placebo group. Patients with advanced tumors will be treated. Different groups of patients will receive different dosages to determine the safety and maximum tolerated dose (MTD) of BAY87-2243. The study will also assess how the drug is metabolized by the body, its biologic effects in the body, and changes in tumor size.
BAY87-2243 will be given as a tablet which dissolves in the gut. Based on findings from this study it may be later given as a tablet which dissolves in the stomach.
BAY87-2243 will be given per mouth, once a day, every day. Treatment will stop if the tumor continues to grow, if side effects occur which the patient can not tolerate or if the patients decides to exit treatment.
The study will be conducted in 3 - 4 centers in 3 countries (Norway, United Kingdom and Germany). The study will have a part where doses are escalated in different groups of patients. Each dose level will be evaluated in a new group of 3 - 6 subjects. This will be followed by an extension part where patients are treated at the highest tolerable dose in groups of up to 25 patients. The extension part will be described in an amendment to the study protocol later. The number of subjects estimated for this study will depend on the number of groups enrolled. The starting dose will be 5 mg given orally as a tablet formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BAY87-2243 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects aged >/= 18 years
- 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 judgement of the investigator, experimental treatment is clinically and ethically acceptable
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Life expectancy of at least 3 month
- Adequate bone marrow, liver, and renal functions
Key exclusion criteria (16 listed)
- History of cardiac disease including congestive heart failure > NYHA (New York Heart Association) II, unstable angina (anginal symptoms at rest), or new-onset angina (within the past 3 months) or myocardial infarction within the past 6 months and cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin
- History of ischemic cardiovascular disease
- Family history of long QT syndrome
- Persistent hypokalemia < 3.5 mmol/L
- History of cerebral ischemia including transient ischemic attack (TIA), prolonged reversible ischemic neurologic deficit (PRIND), and ischemic stroke within the past 6 months
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 |
|---|---|---|
| BAY87-2243Oral administration once daily in a continuous schedule. Starting dose will be 5 mg and dose will be escalated dependent on any dose limiting toxicities. | Drug | Arm 1 |
Primary outcome
Frequency of adverse events
Time frame: Up to 3 years or longer if indicated
Maximum tolerated dose, measured by adverse event profile
Time frame: Up to 3 years or longer if indicated
3 secondary outcomes
Plasma concentrations of BAY87-2243, measured by Cmax, tmax, AUC(0-tn), AUC and half-life
Time frame: Up to 3 years or longer if indicated
Biomarkers evaluation (analysis of carbonic anhydrase 9 and VEGF in plasma)
Time frame: Up to 3 years or longer if indicated
Tumor response evaluation based on RECIST 1.1 every 2 cycles
Time frame: Up to 3 years or longer if indicated
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 30 Jul 2013.
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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
3 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 BAY87-2243 in people with Neoplasms, run by Bayer at 3 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 5 inclusion and 16 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 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Norway, 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 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?
Frequency of adverse events (time frame: Up to 3 years or longer if indicated). The study lists 2 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 Jul 2013.