NeoplasmsPhase 1NCT02211859
Dose Escalation Study of BI 2536 BS in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
A Phase 1 study testing BI 2536 in people with Neoplasms, run by Boehringer Ingelheim.
Trial summary
Primary: Maximum tolerated dose (MTD) Secondary: Determination of the pharmacokinetic profile of BI 2536. Assessment of safety and efficacy. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Dec 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 have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
- Evaluable tumour deposits
- Age 18 years or older
- Life expectancy of at least six months
- Written informed consent consistent with international conference of harmonization (ICH) - good clinical practice (GCP) and local legislation
- Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
- 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 protocol
- Pregnancy or breastfeeding
- Active infectious disease
- Known brain metastases
- Second malignancy requiring therapy
- Absolute neutrophil count less than 1500/mm3
Show all 12Show fewer
- Platelet count less than 100 000/mm3
- Bilirubin greater than 1.5 mg/dl (> 26 μmol/L)
- 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)
- Women and men who are sexually active and 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)
About this study
Official title: An Open Phase I Repeated Dose Escalation Study of BI 2536 BS Administered Intravenously in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
Primary: Maximum tolerated dose (MTD) Secondary: Determination of the pharmacokinetic profile of BI 2536. Assessment of safety and efficacy.
- Conditions
- Neoplasms
- Being tested
- BI 2536
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 2536Drug
| Study group | Role | What they receive |
|---|---|---|
| BI 2536 | Experimental | single escalating dose, followed by repeated administration in patients with clinical benefit Receives: Drug: BI 2536 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the maximum tolerated dose (MTD) by occurrence of dose limiting toxicities (DLT)
Measured: up to 3 weeks
Secondary outcomes (15)
Number of patients with drug-related adverse events
according to common terminology criteria for adverse events (CTCAE) 3.0
Measured: up to 24 days after last drug administration
Number of patients with abnormal laboratory findings
Measured: up to 24 days after last drug administration
Change in Eastern Cooperative Oncology Group (ECOG) performance score
Measured: baseline, up to 24 days after last drug administration
Number of patients with clinically significant changes in vital signs
Measured: up to 24 days after last drug administration
Number of patients with objective tumor response
Measured: up to 24 days after last drug administration
Cmax (maximum concentration of the analyte in plasma)
Measured: up to 264 hours after drug administration
tmax (time from dosing to maximum concentration)
Measured: up to 264 hours after drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 264 hours after drug administration
%AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation)
Measured: up to 264 hours after drug administration
λz (terminal rate constant in plasma)
Measured: up to 264 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 264 hours after drug administration
MRT (mean residence time of the analyte in the body after intravenous administration)
Measured: up to 264 hours after drug administration
CL (total clearance of the analyte in the plasma after intravascular administration)
Measured: up to 264 hours after drug administration
Vz (apparent volume of distribution during the terminal phase λz following an intravascular dose)
Measured: up to 264 hours after drug administration
Vss (apparent volume of distribution at steady state following intravascular administration)
Measured: up to 264 hours after drug 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 completionDec 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 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
- NCT02211859
- Sponsor's protocol ID
- 1216.2
- Status last verified
- Dec 2024
- First submitted
- 7 Aug 2014
- Last updated
- 20 Dec 2024
- Results posted
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Phase I Repeated 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
- NCT02211859
- Acronym / sponsor ID
- 1216.2
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Dec 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.
Primary: Maximum tolerated dose (MTD) Secondary: Determination of the pharmacokinetic profile of BI 2536. Assessment of safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI 2536 | Experimental | Drug: BI 2536single escalating dose, followed by repeated administration in patients with clinical benefit |
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 have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
- Evaluable tumour deposits
- Age 18 years or older
- Life expectancy of at least six months
- Written informed consent consistent with international conference of harmonization (ICH) - good clinical practice (GCP) and local legislation
Key exclusion criteria (12 listed)
- Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the 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 | Drug | BI 2536 |
Primary outcome
Determination of the maximum tolerated dose (MTD) by occurrence of dose limiting toxicities (DLT)
Time frame: up to 3 weeks
15 secondary outcomes
Number of patients with drug-related adverse events
Time frame: up to 24 days after last drug administration
Number of patients with abnormal laboratory findings
Time frame: up to 24 days after last drug administration
Change in Eastern Cooperative Oncology Group (ECOG) performance score
Time frame: baseline, up to 24 days after last drug administration
Number of patients with clinically significant changes in vital signs
Time frame: up to 24 days after last drug administration
Number of patients with objective tumor response
Time frame: up to 24 days after last drug administration
Cmax (maximum concentration of the analyte in plasma)
Time frame: up to 264 hours after drug administration
tmax (time from dosing to maximum concentration)
Time frame: up to 264 hours after drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 264 hours after drug administration
%AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time frame: up to 264 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 264 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 264 hours after drug administration
MRT (mean residence time of the analyte in the body after intravenous administration)
Time frame: up to 264 hours after drug administration
CL (total clearance of the analyte in the plasma after intravascular administration)
Time frame: up to 264 hours after drug administration
Vz (apparent volume of distribution during the terminal phase λz following an intravascular dose)
Time frame: up to 264 hours after drug administration
Vss (apparent volume of distribution at steady state following intravascular administration)
Time frame: up to 264 hours after drug 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 20 Dec 2024.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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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 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 12 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 20 Dec 2024. 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?
Determination of the maximum tolerated dose (MTD) by occurrence of dose limiting toxicities (DLT) (time frame: up to 3 weeks). 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 20 Dec 2024.