NeoplasmsPhase 1NCT00701324
BI 811283 in Various Solid Tumours
A Phase 1 study testing BI 811283 in people with Neoplasms, run by Boehringer Ingelheim at 2 sites in Germany.
Trial summary
The main objective of this trial is to provide safety data in terms of drug-related adverse events (AE) for the recommendation of the dose for further trials in the development of BI 811283. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- BI 811283
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesGermany
- Study dates
- Jun 2007to May 2011
- 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 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 Evaluable tumour deposits Recovery from reversible toxicities of prior anti-cancer therapies Age >= 18 years Life expectancy >= 6 months Written informed consent in accordance with International Conference on Harmonisation (ICH) guideline for Good Clinical Practice (GCP) 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 Known brain metastases Second malignancy requiring therapy Left ventricular ejection fraction (LVEF) < 50% in echocardiography or clinical congestive heart failure New York Heart Association grade III - IV Myocardial infarction within the last 6 months prior to inclusion or symptomatic coronary artery disease Absolute neutrophil count less than 1500 / mm3 Platelet count less than 100 000 / mm3 Bilirubin greater than 1.5 mg / dl (> 26 mcmol / 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 mcmol / 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
2 sites in 1 country.
Germany2 sites
1247.1.49002 Boehringer Ingelheim Investigational Site
Essen
1247.1.49001 Boehringer Ingelheim Investigational Site
Freiburg/Breisgau
About this study
Official title: An Open Phase I Single Dose Escalation Study of Two Dosing Schedules of BI 811283 Administered Intravenously Over 24 h Continuous Infusion in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
The main objective of this trial is to provide safety data in terms of drug-related adverse events (AE) for the recommendation of the dose for further trials in the development of BI 811283.
Secondary objectives are the collection of antitumour efficacy data and the determination of the pharmacokinetic profile of BI 811283.
- Conditions
- Neoplasms
- Being tested
- BI 811283
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 811283Drug
dose escalation BI 811283, Arm B (3 weeks)
BI 811283Drug
dose escalation BI 811283, Arm A (day 1)
BI 811283Drug
dose escalation BI 811283, Arm A (day 15)
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | BI 811283, 24h infusion d1 and d15 every 4 weeks Receives: Drug: BI 811283 |
| Arm B | Experimental | BI 811283, 24h infusion d1 every 3 weeks Receives: Drug: BI 811283 |
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 (2)
Safety profile: incidence and intensity of AEs graded according to the common terminology criteria for AEs, incidence of DLT
Measured: throughout the study period
Progression free survival (PFS), Objective response, Response duration, Pharmacodynamic analysis, Basic pharmacokinetics
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 posted19 Jun 2008 (estimated)
- Study startJun 2007
- Primary completionMay 2011
- Study completionMay 2011
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
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701324
- Sponsor's protocol ID
- 1247.1
- Other IDs
- 2007-000191-17
- Status last verified
- Jul 2014
- First submitted
- 18 Jun 2008
- Last updated
- 22 Jul 2014
- Results posted
- No
Publications
Mross K, Richly H, Frost A, Scharr D, Nokay B, Graeser R, Lee C, Hilbert J, Goeldner RG, Fietz O, Scheulen ME. A phase I study of BI 811283, an Aurora B kinase inhibitor, in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2016 Aug;78(2):405-17. doi: 10.1007/s00280-016-3095-6. Epub 2016 Jun 27.
PubMed 27349901
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Phase I Single Dose Escalation Study of Two Dosing Schedules of BI 811283 Administered Intravenously Over 24 h Continuous Infusion in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
- ClinicalTrials.gov ID
- NCT00701324
- Acronym / sponsor ID
- 1247.1
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 19 Jun 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 (AE) for the recommendation of the dose for further trials in the development of BI 811283.
Secondary objectives are the collection of antitumour efficacy data and the determination of the pharmacokinetic profile of BI 811283.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: BI 811283BI 811283, 24h infusion d1 and d15 every 4 weeks |
| Arm B | Experimental | Drug: BI 811283BI 811283, 24h infusion d1 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 (1 listed)
- Patients with confirmed diagnosis of advanced, non-resectable and/or metastatic solid 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 Evaluable tumour deposits Recovery from reversible toxicities of prior anti-cancer therapies Age >= 18 years Life expectancy >= 6 months Written informed consent in accordance with International Conference on Harmonisation (ICH) guideline for Good Clinical Practice (GCP) and local legislation Eastern Cooperative Oncology Group performance score <= 2
Key exclusion criteria (1 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 Known brain metastases Second malignancy requiring therapy Left ventricular ejection fraction (LVEF) < 50% in echocardiography or clinical congestive heart failure New York Heart Association grade III - IV Myocardial infarction within the last 6 months prior to inclusion or symptomatic coronary artery disease Absolute neutrophil count less than 1500 / mm3 Platelet count less than 100 000 / mm3 Bilirubin greater than 1.5 mg / dl (> 26 mcmol / 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 mcmol / 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
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 |
|---|---|---|
| BI 811283dose escalation BI 811283, Arm B (3 weeks) | Drug | Arm B |
| BI 811283dose escalation BI 811283, Arm A (day 1) | Drug | Arm A |
| BI 811283dose escalation BI 811283, Arm A (day 15) | Drug | Arm A |
Primary outcome
Maximum tolerated dose
Time frame: 3-4 weeks
2 secondary outcomes
Safety profile: incidence and intensity of AEs graded according to the common terminology criteria for AEs, incidence of DLT
Time frame: throughout the study period
Progression free survival (PFS), Objective response, Response duration, Pharmacodynamic analysis, Basic pharmacokinetics
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 22 Jul 2014.
- Derived from this study: PubMed 27349901Mross K, Richly H, Frost A, Scharr D, Nokay B, Graeser R, Lee C, Hilbert J, Goeldner RG, Fietz O, Scheulen ME. A phase I study of BI 811283, an Aurora B kinase inhibitor, in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2016 Aug;78(2):405-17. doi: 10.1007/s00280-016-3095-6. Epub 2016 Jun 27.
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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
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 BI 811283 in people with Neoplasms, run by Boehringer Ingelheim at 2 sites in Germany.
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 1 inclusion and 1 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 22 Jul 2014. 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 Germany. 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 NCT00701324, 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 22 Jul 2014.