NeoplasmsPhase 1NCT02211872
BI 2536 BS in Patients With Advanced Solid Tumours and Repeated Administration in Patients With Clinical Benefit
A Phase 1 study testing BI 2536 BS, intravenous in people with Neoplasms, run by Boehringer Ingelheim.
Trial summary
The primary objective of this study was to determine the maximum tolerated dose (MTD) of BI 2536 BS in patients with advanced solid tumours. Secondary objectives were the evaluation of safety, efficacy, and pharmacokinetics of BI 2536 BS 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 2536 BS, intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Mar 2007
- 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 had failed conventional treatment, or for whom no therapy of proven efficacy exists, or who were not amenable to established forms of treatment
- Evaluable tumour deposits
- Age of 18 years or older
- Life expectancy of at least 6 months
- Written informed consent consistent with international conference of harmonization (ICH) - good clinical practice (GCP) and local legislation
- Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score ≤ 2
- And full recovery from all therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies
Who cannot join
- Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the trial protocol
- Pregnancy or breastfeeding
- Active infectious disease
- Known brain metastases
- Second malignancy requiring therapy
- Absolute neutrophil count less than 1500/mm3
Show all 15Show fewer
- Platelet count less than 100 000/mm3
- Bilirubin greater than 1.5 mg/dL (> 26 μmol/L, international system of units (SI) 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 μmol/L, SI unit equivalent)
- Sexually active women and men who are unwilling to use a medically acceptable method of contraception
- Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
- Chemo-, radio or immunotherapy within the past four weeks before start of therapy or concomitantly with this trial
- Patients unable to comply with the trial protocol
- Or active alcohol or drug abuse
About this study
Official title: An Open Phase I Single Dose Escalation Study of BI 2536 BS Administered Intravenously in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
The primary objective of this study was to determine the maximum tolerated dose (MTD) of BI 2536 BS in patients with advanced solid tumours. Secondary objectives were the evaluation of safety, efficacy, and pharmacokinetics of BI 2536 BS
- Conditions
- Neoplasms
- Being tested
- BI 2536 BS, intravenous
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 2536 BS, intravenousDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | BI 2536 BS single rising dose Receives: Drug: BI 2536 BS, intravenous |
| Treatment B | Experimental | BI 2536 BS multiple rising doses on three consecutive days (d1-3 schedule) Receives: Drug: BI 2536 BS, intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) for a single dose of BI 2536 BS
Measured: Up to 16 weeks
MTD for single doses of BI 2536 BS on 3 consecutive days
Measured: Up to 16 weeks
Secondary outcomes (15)
Assessment of objective treatment response by tumour measurements
Evaluated according to the response evaluation criteria in solid tumors (RECIST)
Measured: Up to 1 year
Number of patients with adverse events
Measured: Up to 1 year
Maximum concentration of BI 2536 BS analyte in plasma (Cmax)
Measured: Pre-dose, up to 216 hours after drug administration
Time from dosing to maximum concentration of BI 2536 BS in plasma (tmax)
Measured: Pre-dose, up to 216 hours after drug administration
Area under the concentration-time curve of BI 2536 BS in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: Pre-dose, up to 216 hours after drug administration
Percentage of the AUC0-∞ that is obtained by extrapolation (%AUC0-tz)
Measured: Pre-dose, up to 216 hours after drug administration
Terminal rate constant in plasma (λz)
Measured: Pre-dose, up to 216 hours after drug administration
Terminal half-life of BI 2536 BS in plasma (t1/2)
Measured: Pre-dose, up to 216 hours after drug administration
Mean residence time of BI 2536 BS in the body after intravenous administration (MRT)
Measured: Pre-dose, up to 216 hours after drug administration
Total clearance of BI 2536 BS in the plasma after intravascular administration (CL)
Measured: Pre-dose, up to 216 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an intravascular dose (Vz)
Measured: Pre-dose, up to 216 hours after drug administration
Apparent volume of distribution at steady state following intravascular administration (Vss)
Measured: Pre-dose, up to 216 hours after drug administration
Amount of BI 2536 BS that is eliminated in urine from the time point 0 to time point 24/48 (Ae0-24/48)
Measured: Pre-dose, up to 48 hours after drug administration
Fraction of analyte eliminated in urine from time point 0 to time point 24/48 (fe0-24/48)
Measured: Pre-dose, up to 48 hours after drug administration
Renal clearance of BI 2536 BS from the time point 0 to time point 24/48 (CLR,0-24/48)
Measured: Pre-dose, up to 48 hours afterdrug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startAug 2004
- Primary completionMar 2007
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211872
- Sponsor's protocol ID
- 1216.1
- Status last verified
- Aug 2014
- First submitted
- 7 Aug 2014
- Last updated
- 8 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 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 BI 2536 BS Administered Intravenously in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
- ClinicalTrials.gov ID
- NCT02211872
- Acronym / sponsor ID
- 1216.1
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Mar 2007 (actual)
- First posted
- 8 Aug 2014 (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 primary objective of this study was to determine the maximum tolerated dose (MTD) of BI 2536 BS in patients with advanced solid tumours. Secondary objectives were the evaluation of safety, efficacy, and pharmacokinetics of BI 2536 BS
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: BI 2536 BS, intravenousBI 2536 BS single rising dose |
| Treatment B | Experimental | Drug: BI 2536 BS, intravenousBI 2536 BS multiple rising doses on three consecutive days (d1-3 schedule) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who had failed conventional treatment, or for whom no therapy of proven efficacy exists, or who were not amenable to established forms of treatment
- Evaluable tumour deposits
- Age of 18 years or older
- Life expectancy of at least 6 months
- Written informed consent consistent with international conference of harmonization (ICH) - good clinical practice (GCP) and local legislation
Key exclusion criteria (15 listed)
- Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the trial protocol
- Pregnancy or breastfeeding
- Active infectious disease
- Known brain metastases
- Second malignancy requiring therapy
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 2536 BS, intravenous | Drug | Treatment A, Treatment B |
Primary outcome
Maximum tolerated dose (MTD) for a single dose of BI 2536 BS
Time frame: Up to 16 weeks
MTD for single doses of BI 2536 BS on 3 consecutive days
Time frame: Up to 16 weeks
15 secondary outcomes
Assessment of objective treatment response by tumour measurements
Time frame: Up to 1 year
Number of patients with adverse events
Time frame: Up to 1 year
Maximum concentration of BI 2536 BS analyte in plasma (Cmax)
Time frame: Pre-dose, up to 216 hours after drug administration
Time from dosing to maximum concentration of BI 2536 BS in plasma (tmax)
Time frame: Pre-dose, up to 216 hours after drug administration
Area under the concentration-time curve of BI 2536 BS in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Pre-dose, up to 216 hours after drug administration
Percentage of the AUC0-∞ that is obtained by extrapolation (%AUC0-tz)
Time frame: Pre-dose, up to 216 hours after drug administration
Terminal rate constant in plasma (λz)
Time frame: Pre-dose, up to 216 hours after drug administration
Terminal half-life of BI 2536 BS in plasma (t1/2)
Time frame: Pre-dose, up to 216 hours after drug administration
Mean residence time of BI 2536 BS in the body after intravenous administration (MRT)
Time frame: Pre-dose, up to 216 hours after drug administration
Total clearance of BI 2536 BS in the plasma after intravascular administration (CL)
Time frame: Pre-dose, up to 216 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an intravascular dose (Vz)
Time frame: Pre-dose, up to 216 hours after drug administration
Apparent volume of distribution at steady state following intravascular administration (Vss)
Time frame: Pre-dose, up to 216 hours after drug administration
Amount of BI 2536 BS that is eliminated in urine from the time point 0 to time point 24/48 (Ae0-24/48)
Time frame: Pre-dose, up to 48 hours after drug administration
Fraction of analyte eliminated in urine from time point 0 to time point 24/48 (fe0-24/48)
Time frame: Pre-dose, up to 48 hours after drug administration
Renal clearance of BI 2536 BS from the time point 0 to time point 24/48 (CLR,0-24/48)
Time frame: Pre-dose, up to 48 hours afterdrug administration
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 8 Aug 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 2536 BS, intravenous in people with Neoplasms, run by Boehringer Ingelheim.
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 7 inclusion and 15 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 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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 (MTD) for a single dose of BI 2536 BS (time frame: Up to 16 weeks). 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 8 Aug 2014.