NeoplasmsPhase 1NCT00756223
Phase I Study of BI 831266 in Patients With Advanced Solid Tumours
A Phase 1 study testing Arm A and Arm B in people with Neoplasms, run by Boehringer Ingelheim at 3 sites in Austria.
Trial summary
The main objective of this trial is to provide safety data in terms of drug-related adverse events for the recommendation of the dose for further trials in the development of BI 831266. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Arm A and Arm B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesAustria
- Study dates
- Nov 2008to Oct 2010
- 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
- Patients with confirmed diagnosis of advanced, non-resectable and/or metastatic solid malignant tumours, who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options
- Secure central venous access
- Measurable and/or non-measurable tumour deposits
- Recovery from toxicities of prior anti-cancer therapies at least to CTCAE grade 1
- Age >= 18 years
- Life expectancy >= 3 months
- Written informed consent in accordance with International Conference on Harmonisation guideline for Good Clinical Practice and local legislation
- Eastern Cooperative Oncology Group performance score <= 2
Who cannot join
- Serious illness, concomitant non-oncological disease (e.g. active infectious disease), or ongoing toxicity of prior therapies considered by the investigator to potentially compromise patients' safety in this trial
- Pregnancy or breastfeeding
- Symptomatic brain metastases and/or leptomeningeal disease requiring therapy
- Second malignancy requiring therapy
- Left ventricular ejection fraction (LVEF) < 50% in echocardiography
- Clinically significant (i.e. active) cardiovascular disease: CVA/stroke (<= 6 months prior to randomisation), myocardial infarction (<= 6 months prior to randomisation), unstable angina, New York Heart Association Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
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- Absolute neutrophil count less than 1500 / mm3
- Platelet count less than 100 000 / mm3
- Bilirubin greater than 1.5 mg / dl (> 26 micromol / L, SI unit equivalent)
- Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
- Serum creatinine greater than 1.5 mg / dl (> 132 micromol / L, SI unit equivalent)
- Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
- Treatment with other investigational drugs or in another clinical trial within the past two weeks before start of therapy or concomitantly with this trial
- Chemo-, hormone, radio- or immunotherapy within the past two weeks before start of therapy or concomitantly with this trial
- Patients unable to comply with the protocol
- Active alcohol or drug abuse
Trial locations and contacts
3 sites in 1 country.
Austria3 sites
1257.1.4303 Boehringer Ingelheim Investigational Site
Linz
1257.1.4302 Boehringer Ingelheim Investigational Site
Salzburg
1257.1.4301 Boehringer Ingelheim Investigational Site
Vienna
About this study
Official title: An Open-label Phase I Single Dose Escalation Trial of Two Dosing Schedules of BI 831266 Administered Intravenously Over 24 h Continuously in Patients With Advanced Solid Tumours
The main objective of this trial is to provide safety data in terms of drug-related adverse events for the recommendation of the dose for further trials in the development of BI 831266.
Secondary objectives are the collection of antitumour efficacy data and the determination of the pharmacokinetic and pharmacodynamic profile of BI 831266.
- Conditions
- Neoplasms
- Being tested
- Arm A, Arm B
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm ADrug
Dose escalation Arm A (4 weeks)
Arm BDrug
Dose escalation Arm B (3 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | BI 831266 24h infusion on day 1 and day 15 every 4 weeks Receives: Drug: Arm A |
| Arm B | Experimental | BI 831266 24h infusion on day 1 every 3 weeks Receives: Drug: Arm B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: 3-4 weeks
Secondary outcomes (4)
Safety parameters (incidence and intensity of AEs graded according to the common terminology criteria for AEs and incidence of DLT)
Measured: throughout the study period
Pharmacokinetic parameters
Measured: throughout the study period
Pharmacodynamic analysis
Measured: 3-4 weeks
Efficacy data (progression free survival, objective response rate, response duration)
Measured: throughout the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2010
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 Boehringer IngelheimThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756223
- Sponsor's protocol ID
- 1257.1
- Other IDs
- 2008-001631-36, 2008
- Status last verified
- Nov 2013
- First submitted
- 19 Sep 2008
- Last updated
- 21 Nov 2013
- Results posted
- No
Publications
Dittrich C, Fridrik MA, Koenigsberg R, Lee C, Goeldner RG, Hilbert J, Greil R. A phase 1 dose escalation study of BI 831266, an inhibitor of Aurora kinase B, in patients with advanced solid tumors. Invest New Drugs. 2015 Apr;33(2):409-22. doi: 10.1007/s10637-014-0201-7. Epub 2014 Dec 23.
PubMed 25529193
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase I Single Dose Escalation Trial of Two Dosing Schedules of BI 831266 Administered Intravenously Over 24 h Continuously in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT00756223
- Acronym / sponsor ID
- 1257.1
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Oct 2010 (actual)
- First posted
- 22 Sep 2008 (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.
The main objective of this trial is to provide safety data in terms of drug-related adverse events for the recommendation of the dose for further trials in the development of BI 831266.
Secondary objectives are the collection of antitumour efficacy data and the determination of the pharmacokinetic and pharmacodynamic profile of BI 831266.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Arm ABI 831266 24h infusion on day 1 and day 15 every 4 weeks |
| Arm B | Experimental | Drug: Arm BBI 831266 24h infusion on day 1 every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with confirmed diagnosis of advanced, non-resectable and/or metastatic solid malignant tumours, who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options
- Secure central venous access
- Measurable and/or non-measurable tumour deposits
- Recovery from toxicities of prior anti-cancer therapies at least to CTCAE grade 1
- Age >= 18 years
Key exclusion criteria (16 listed)
- Serious illness, concomitant non-oncological disease (e.g. active infectious disease), or ongoing toxicity of prior therapies considered by the investigator to potentially compromise patients' safety in this trial
- Pregnancy or breastfeeding
- Symptomatic brain metastases and/or leptomeningeal disease requiring therapy
- Second malignancy requiring therapy
- Left ventricular ejection fraction (LVEF) < 50% in echocardiography
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 |
|---|---|---|
| Arm ADose escalation Arm A (4 weeks) | Drug | Arm A |
| Arm BDose escalation Arm B (3 weeks) | Drug | Arm B |
Primary outcome
Maximum tolerated dose
Time frame: 3-4 weeks
4 secondary outcomes
Safety parameters (incidence and intensity of AEs graded according to the common terminology criteria for AEs and incidence of DLT)
Time frame: throughout the study period
Pharmacokinetic parameters
Time frame: throughout the study period
Pharmacodynamic analysis
Time frame: 3-4 weeks
Efficacy data (progression free survival, objective response rate, response duration)
Time frame: throughout the study period
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 Nov 2013.
- Derived from this study: PubMed 25529193Dittrich C, Fridrik MA, Koenigsberg R, Lee C, Goeldner RG, Hilbert J, Greil R. A phase 1 dose escalation study of BI 831266, an inhibitor of Aurora kinase B, in patients with advanced solid tumors. Invest New Drugs. 2015 Apr;33(2):409-22. doi: 10.1007/s10637-014-0201-7. Epub 2014 Dec 23.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
3 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 Arm A and Arm B in people with Neoplasms, run by Boehringer Ingelheim at 3 sites in Austria.
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 8 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: finished, as of the sponsor's last update on 21 Nov 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 Austria. 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?
Maximum tolerated dose (time frame: 3-4 weeks). 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 NCT00756223, 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 21 Nov 2013.