NeoplasmsPhase 1NCT01028755
To Determine Maximum Tolerated Dose of BAY79-4620 in Patients With Advanced Solid Tumors
A Phase 1 study testing BAY79-4620 in people with Neoplasms, run by Bayer at 2 sites in United States.
Trial summary
This is the first time this drug will be tested in humans in order to determine the safety of the drug, the ability to tolerate the drug, to measure how the drug is used in the body and as a result of these tests to determine a maximum dose to be given. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- BAY79-4620
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2009to Apr 2013
- 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
- Age greater than/equal to 18 years old.
- ECOG Performance Status of 0 - 2
- Life expectancy of at least 12 weeks
- Patients with advanced, histologically or cytological confirmed solid tumors, refractory to any standard therapy or have no standard therapy available
- Radiographically or clinically evaluable tumor
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 14 days prior to start of first dose:
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- Hemoglobin > 10.0 g/dL
- Absolute neutrophil count (ANC) > or = 1500/mm3
- Platelet count > or = 100,000 /mm3
- Total bilirubin < or = 1.5 times the upper limit of normal
- ALT and AST < or = 2.5 x upper limit of normal (< or = 5 x upper limit of normal for patients with liver involvement)
- INR less than or = 1.5 and a PTT within normal limits (patients who do not undergo an anticoagulative treatment, but have an abnormal high PTT while INR is normal, indicating towards an artificial PTT elevation caused by heparinized, are eligible.
- Serum creatinine < 1.5 times the upper limit of normal
Who cannot join
- History of impaired cardiac function or clinically significant cardiac disease (i.e. congestive heart failure (CHF) NYHA Class III or IV); myocardial infarction, unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy < 6 months prior to study entry (beta blockers or digoxin are permitted) and LVEF <40% (as measured at screening by MUGA or echocardiogram).
- Patients with amylase or lipase greater than upper limit of normal range per local laboratory
- History of pancreatitis
- Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management
- Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has no evidence of tumor growth on an imaging study within 2 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry.
- Patients with severe renal impairment or on dialysis
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- Known human immunodeficiency virus (HIV) infection or patients with an active hepatitis B or C infection necessitating treatment. Patients with chronic hepatitis B or C are eligible
- Active clinically serious infections > CTCAE Grade 2
- Serious, non-healing wound, ulcer, or bone fracture
- Known or suspected allergy or intolerance to any agent given in the course of this trial
- Previous cancer that is distinct in primary site or histology from actual disease EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors [Ta and Tis] or any cancer curatively treated > 3 years prior to study entry
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Nashville, Tennessee, 37203
Study site
San Antonio, Texas, 78229-3307
About this study
Official title: An Open Label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY79-4620 in Patients With Advanced Solid Tumors
This is the first time this drug will be tested in humans in order to determine the safety of the drug, the ability to tolerate the drug, to measure how the drug is used in the body and as a result of these tests to determine a maximum dose to be given. Specifically, the following aspects will be investigated:
- side effects of BAY79-4620 given as infusion every three weeks
- evaluation of highest and safest dose of BAY79-4620
- distribution and concentration of BAY79-4620 in the blood at specific times after administration
- effect of BAY79-4620 on tumor growth
- assessment of "biomarkers" (eg, analysis of specific proteins in blood samples, or analysis of tumor tissue sampled at the time of cancer diagnosis) for changes during the treatment or prediction of safety or benefits of the treatment with BAY79-4620.
- Conditions
- Neoplasms
- Being tested
- BAY79-4620
- Keywords
- Maximum Tolerated Dose
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY79-4620Drug
BAY79-4620 will be administered as 1 hour IV infusion. Dose escalation will be dependent on any dose limiting toxicities
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: BAY79-4620 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, tolerability, maximum tolerated dose
Measured: 2 years
Pharmacokinetics profile of BAY79-4620 and its key metabolites
Measured: 2 years
Secondary outcomes (3)
Biomarker evaluation
Measured: 2 years
Tumor response
Measured: 2 years
Immunogenicity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2013
- Study completionApr 2013
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
- 12 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
- NCT01028755
- Sponsor's protocol ID
- 12671
- Status last verified
- Jan 2015
- First submitted
- 4 Nov 2009
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY79-4620 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01028755
- Acronym / sponsor ID
- 12671
- Conditions
- Neoplasms
- Keywords
- Maximum Tolerated Dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Dec 2009 (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 time this drug will be tested in humans in order to determine the safety of the drug, the ability to tolerate the drug, to measure how the drug is used in the body and as a result of these tests to determine a maximum dose to be given. Specifically, the following aspects will be investigated:
- side effects of BAY79-4620 given as infusion every three weeks
- evaluation of highest and safest dose of BAY79-4620
- distribution and concentration of BAY79-4620 in the blood at specific times after administration
- effect of BAY79-4620 on tumor growth
- assessment of "biomarkers" (eg, analysis of specific proteins in blood samples, or analysis of tumor tissue sampled at the time of cancer diagnosis) for changes during the treatment or prediction of safety or benefits of the treatment with BAY79-4620.
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: BAY79-4620 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age greater than/equal to 18 years old.
- ECOG Performance Status of 0 - 2
- Life expectancy of at least 12 weeks
- Patients with advanced, histologically or cytological confirmed solid tumors, refractory to any standard therapy or have no standard therapy available
- Radiographically or clinically evaluable tumor
Key exclusion criteria (11 listed)
- History of impaired cardiac function or clinically significant cardiac disease (i.e. congestive heart failure (CHF) NYHA Class III or IV); myocardial infarction, unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy < 6 months prior to study entry (beta blockers or digoxin are permitted) and LVEF <40% (as measured at screening by MUGA or echocardiogram).
- Patients with amylase or lipase greater than upper limit of normal range per local laboratory
- History of pancreatitis
- Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management
- Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has no evidence of tumor growth on an imaging study within 2 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry.
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 |
|---|---|---|
| BAY79-4620BAY79-4620 will be administered as 1 hour IV infusion. Dose escalation will be dependent on any dose limiting toxicities | Drug | Arm 1 |
Primary outcome
Safety, tolerability, maximum tolerated dose
Time frame: 2 years
Pharmacokinetics profile of BAY79-4620 and its key metabolites
Time frame: 2 years
3 secondary outcomes
Biomarker evaluation
Time frame: 2 years
Tumor response
Time frame: 2 years
Immunogenicity
Time frame: 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 21 Jan 2015.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY79-4620 in people with Neoplasms, run by Bayer at 2 sites in United States.
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 13 inclusion and 11 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 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Safety, tolerability, maximum tolerated dose (time frame: 2 years). 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 21 Jan 2015.