NeoplasmsPhase 1NCT01764828
BAY86-9766 Plus Gemcitabine Phase I Study in Asian
A Phase 1 study testing Refametinib (BAY86-9766) and Gemcitabine in people with Neoplasms, run by Bayer at 3 sites in 3 countries.
Trial summary
This is an open-label, uncontrolled, Phase Ib study designed to evaluate the safety, tolerability, and pharmacokinetics of BAY86-9766 when given as a single agent and in combination with gemcitabine in Asian patients with advanced or refractory solid tumors.Blood samples for PK (pharmacokinetics) analyses will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Refametinib (BAY86-9766) and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 5 Feb 2013to 10 Feb 2015
- 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 >/= 18 years of age, with histologically or cytologically documented advanced or refractory solid tumors not amenable to standard therapy
- Patients must have at least one measurable or evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Patients must have a life expectancy of at least 12 weeks, and an Eastern Cooperative Oncology Group Performance Status (ECOG PS) </=1.
Who cannot join
- History of cardiac disease
- Active clinically serious infections > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
- Known human immunodeficiency virus (HIV) infection
- Uncontrolled seizure disorder
- Undergoing renal dialysis
- Known bleeding diathesis
- History of organ allograft
- Pregnant or breast feeding women
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Multi-center, Phase Ib Study of MEK (Mitogen Activated Protein Kinase/ERK Kinase) Inhibitor BAY86-9766 Plus Gemcitabine in Asian Patients With Advanced or Refractory Solid Tumors
This is an open-label, uncontrolled, Phase Ib study designed to evaluate the safety, tolerability, and pharmacokinetics of BAY86-9766 when given as a single agent and in combination with gemcitabine in Asian patients with advanced or refractory solid tumors.Blood samples for PK (pharmacokinetics) analyses will be collected after a single dose of BAY86-9766, multiple doses of BAY86-9766, and combination treatment of gemcitabine and BAY86-9766.
Safety evaluation will include adverse events assessment, vital signs, laboratory tests, 12-lead ECG ECG (electrocardiography), cardiac function test, and ophthalmologic examination at various time points during the study.
- Conditions
- Neoplasms
- Being tested
- Refametinib (BAY86-9766), Gemcitabine
- Keywords
- Phase I, Pharmacokinetics, Safety measurements
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refametinib (BAY86-9766)Drug
GemcitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Refametinib (BAY86-9766)+ Gemcitabine | Experimental | Single dose of BAY86-9766 on Cycle 1 Day -17; twice daily dosing every day starting on day -14, start dose 50mg bid ( 30mg or 20mg are possible based on adverse events need) in addition with Gemcitabine intravenous on day 1,8 and 15 1000mg/m2 Receives: Drug: Refametinib (BAY86-9766); Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of BAY86-9766
Measured: Multiple time points up to 6 day
Plasma concentration of M17 and M11
Measured: Multiple time points up to 6 day
Plasma concentration of Gemcitabine
Measured: Multiple time points up to 6 day
Plasma concentration of dFdU
Measured: Multiple time points up to 6 day
Number of adverse events, or abnormal parameters as a measure of safety and tolerability
Parameters are laboratory parameters, vital signs, ECG parameters, cardiac function, and parameters of ophthalmologic examinations
Measured: Up to 1 year
Secondary outcomes (1)
Efficacy of BAY86-9766 shown by a discrete scale
Elements of the scale are :Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study start5 Feb 2013
- Primary completion18 Dec 2014
- Study completion10 Feb 2015
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT01764828
- Sponsor's protocol ID
- 14747
- Status last verified
- Oct 2018
- First submitted
- 8 Jan 2013
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Phase Ib Study of MEK (Mitogen Activated Protein Kinase/ERK Kinase) Inhibitor BAY86-9766 Plus Gemcitabine in Asian Patients With Advanced or Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT01764828
- Acronym / sponsor ID
- 14747
- Conditions
- Neoplasms
- Keywords
- Phase I, Pharmacokinetics, Safety measurements
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2013 (actual)
- Primary completion
- 18 Dec 2014 (actual)
- Study completion
- 10 Feb 2015 (actual)
- First posted
- 10 Jan 2013 (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 an open-label, uncontrolled, Phase Ib study designed to evaluate the safety, tolerability, and pharmacokinetics of BAY86-9766 when given as a single agent and in combination with gemcitabine in Asian patients with advanced or refractory solid tumors.Blood samples for PK (pharmacokinetics) analyses will be collected after a single dose of BAY86-9766, multiple doses of BAY86-9766, and combination treatment of gemcitabine and BAY86-9766.
Safety evaluation will include adverse events assessment, vital signs, laboratory tests, 12-lead ECG ECG (electrocardiography), cardiac function test, and ophthalmologic examination at various time points during the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Refametinib (BAY86-9766)+ Gemcitabine | Experimental | Drug: Refametinib (BAY86-9766), Drug: GemcitabineSingle dose of BAY86-9766 on Cycle 1 Day -17; twice daily dosing every day starting on day -14, start dose 50mg bid ( 30mg or 20mg are possible based on adverse events need) in addition with Gemcitabine intravenous on day 1,8 and 15 1000mg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients >/= 18 years of age, with histologically or cytologically documented advanced or refractory solid tumors not amenable to standard therapy
- Patients must have at least one measurable or evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Patients must have a life expectancy of at least 12 weeks, and an Eastern Cooperative Oncology Group Performance Status (ECOG PS) </=1.
Key exclusion criteria (8 listed)
- History of cardiac disease
- Active clinically serious infections > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
- Known human immunodeficiency virus (HIV) infection
- Uncontrolled seizure disorder
- Undergoing renal dialysis
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 |
|---|---|---|
| Refametinib (BAY86-9766) | Drug | Refametinib (BAY86-9766)+ Gemcitabine |
| Gemcitabine | Drug | Refametinib (BAY86-9766)+ Gemcitabine |
Primary outcome
Plasma concentration of BAY86-9766
Time frame: Multiple time points up to 6 day
Plasma concentration of M17 and M11
Time frame: Multiple time points up to 6 day
Plasma concentration of Gemcitabine
Time frame: Multiple time points up to 6 day
Plasma concentration of dFdU
Time frame: Multiple time points up to 6 day
Number of adverse events, or abnormal parameters as a measure of safety and tolerability
Time frame: Up to 1 year
Parameters are laboratory parameters, vital signs, ECG parameters, cardiac function, and parameters of ophthalmologic examinations
1 secondary outcome
Efficacy of BAY86-9766 shown by a discrete scale
Time frame: Up to 1 year
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 1 Nov 2018.
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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 Refametinib (BAY86-9766) and Gemcitabine 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 3 inclusion and 8 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 1 Nov 2018. 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 China, Japan, South Korea. 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?
Plasma concentration of BAY86-9766 (time frame: Multiple time points up to 6 day). 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 1 Nov 2018.