NeoplasmsPhase 1NCT01881217
First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors
A Phase 1 study testing BAY1179470 in people with Neoplasms, run by Bayer at 8 sites in 3 countries.
Trial summary
An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjects with advanced, refractory solid tumors Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- BAY1179470
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 28 Jun 2013to 16 Aug 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with advanced, histologically or cytologically confirmed solid tumors refractory to any standard therapy or have no standard therapy available or subjects actively refuse any treatment which would be regarded standard
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 and a life expectancy of at least 3 months
- Adequate bone marrow, liver, and renal function.
- For subjects in the additional cohort:
- Subjects with advanced, histologically or cytologically confirmed gastric cancer.
- At least moderate FGFR2 expression in the tumor tissue from archival samples is confirmed
Who cannot join
- History of severe allergic reactions to monoclonal antibody therapy
- Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management
- Any condition that is unstable or could jeopardize the safety of the subject and his / her compliance in the study
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Japan5 sites
Study site
Chuo-ku, Tokyo, 104-0045
Study site
Fukuoka, 811-1395
Study site
Kashiwa, Chiba, 277-8577
Study site
Kita-Adachigun, Saitama, 362-0806
Study site
Koto-ku, Tokyo, 135-8550
About this study
Official title: An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous BAY 1179470 in Subjects With Advanced, Refractory Solid Tumors.
An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjects with advanced, refractory solid tumors
- Conditions
- Neoplasms
- Being tested
- BAY1179470
- Keywords
- Phase I, Dose escalation, Advanced, refractory solid tumors, FGFR2
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1179470Drug
BAY1179470 will be administered as a 1-hour intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| BAY1179470 (Dose escalation) | Experimental | BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days. Receives: Drug: BAY1179470 |
| BAY1179470 (additional) | Experimental | Additional cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days. Receives: Drug: BAY1179470 |
| BAY1179470 (expansion) | Experimental | Expansion cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days. Receives: Drug: BAY1179470 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Up to 2 years
Maximum drug concentration versus time curve (AUC) from zero to infinity after single (first) and multiple doses of BAY1179470
Measured: Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days
Maximum drug concentration (Cmax) and minimal drug concentration (Cmin) of BAY1179470 in plasma after single and multiple dose administration
Measured: Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days
Secondary outcomes (4)
Tumor response
Tumor response will be evaluated based on the RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria.
Measured: Every 42 days
Biomarker (plasma)
Measured: Cycle 1: pre-dose, 24 hours after start of the infusion and Day 15, Cycle 2, 3 and 4: pre-dose; each cycle is 21 days
Biomarker (biopsy)
Additional cohort only
Measured: Cycle 1: pre-dose and Day 8; cycle 1 is 21 days
Immunogenicity
Analyzed for anti-BAY 1179470 antibodies
Measured: Cycle 1 and Cycle 2 pre-dose and every second cycle thereafter pre-dose. End of treatment visit and follow-up visit up to 2 years; each cycle is 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study start28 Jun 2013
- Primary completion18 Mar 2016
- Study completion16 Aug 2016
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT01881217
- Sponsor's protocol ID
- 16182
- Status last verified
- Sep 2017
- First submitted
- 17 Jun 2013
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. 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 Pharmacodynamics of Intravenous BAY 1179470 in Subjects With Advanced, Refractory Solid Tumors.
- ClinicalTrials.gov ID
- NCT01881217
- Acronym / sponsor ID
- 16182
- Conditions
- Neoplasms
- Keywords
- Phase I, Dose escalation, Advanced, refractory solid tumors, FGFR2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2013 (actual)
- Primary completion
- 18 Mar 2016 (actual)
- Study completion
- 16 Aug 2016 (actual)
- First posted
- 19 Jun 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.
An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjects with advanced, refractory solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BAY1179470 (Dose escalation) | Experimental | Drug: BAY1179470BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days. |
| BAY1179470 (additional) | Experimental | Drug: BAY1179470Additional cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days. |
| BAY1179470 (expansion) | Experimental | Drug: BAY1179470Expansion cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with advanced, histologically or cytologically confirmed solid tumors refractory to any standard therapy or have no standard therapy available or subjects actively refuse any treatment which would be regarded standard
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 and a life expectancy of at least 3 months
- Adequate bone marrow, liver, and renal function.
- Subjects with advanced, histologically or cytologically confirmed gastric cancer.
- At least moderate FGFR2 expression in the tumor tissue from archival samples is confirmed
Key exclusion criteria (3 listed)
- History of severe allergic reactions to monoclonal antibody therapy
- Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management
- Any condition that is unstable or could jeopardize the safety of the subject and his / her compliance in the study
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 |
|---|---|---|
| BAY1179470BAY1179470 will be administered as a 1-hour intravenous infusion. | Drug | BAY1179470 (Dose escalation), BAY1179470 (additional), BAY1179470 (expansion) |
Primary outcome
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 2 years
Maximum drug concentration versus time curve (AUC) from zero to infinity after single (first) and multiple doses of BAY1179470
Time frame: Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days
Maximum drug concentration (Cmax) and minimal drug concentration (Cmin) of BAY1179470 in plasma after single and multiple dose administration
Time frame: Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days
4 secondary outcomes
Tumor response
Time frame: Every 42 days
Biomarker (plasma)
Time frame: Cycle 1: pre-dose, 24 hours after start of the infusion and Day 15, Cycle 2, 3 and 4: pre-dose; each cycle is 21 days
Biomarker (biopsy)
Time frame: Cycle 1: pre-dose and Day 8; cycle 1 is 21 days
Immunogenicity
Time frame: Cycle 1 and Cycle 2 pre-dose and every second cycle thereafter pre-dose. End of treatment visit and follow-up visit up to 2 years; each cycle is 21 days
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 14 Sep 2017.
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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
8 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 BAY1179470 in people with Neoplasms, run by Bayer at 8 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 6 inclusion and 3 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 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan, Singapore, 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?
Number of participants with Adverse Events as a Measure of Safety and Tolerability (time frame: Up to 2 years). The study lists 3 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 14 Sep 2017.