TumorsPhase 1NCT02182128
A Dose-escalation Study of BIBF 1120 in Japanese Patients With Advanced Solid Tumours
A Phase 1 study testing BIBF 1120 in people with Tumors, run by Boehringer Ingelheim.
Trial summary
Confirmation of BIBF 1120 administered from 150 mg twice daily (b.i.d.) to 250 mg b.i.d. as safe and tolerable treatment in Japanese patients with advanced solid tumours, overall safety, pharmacokinetic parameters, biomarkers, and efficacy of BIBF 1120. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Tumors
- What is being tested?
- BIBF 1120
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Jun 2009
- 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
- Male or female patients with a confirmed diagnosis of an advanced, non resectable and/or metastatic solid tumour (except for malignant lymphoma)
- Patients who have not responded to conventional treatment, or for whom no therapy of proven efficacy was available, or who were not amenable to established forms of treatment
- Patients recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radio-therapies (except for epilation) at least over the following periods of time:
- four weeks after chemotherapy (at least 2 weeks after receiving antimetabolite or at least 6 weeks after nitrosourea or mitomycin C)
- two weeks after receiving hormone therapy
- four weeks after receiving radiation therapy (2 weeks after radiation for symptom control)
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- two weeks after receiving immunotherapy
- four weeks after surgical procedures
- Age 20 years or older
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2
- Patients retaining a significant physiological compensatory function and without manifest marked disorders of the hematopoietic system, heart, lung, liver, kidneys, etc., i.e., patients with sufficient baseline organ function
- An absolute neutrophil count more than 1500/mm3
- A platelet count more than 100000/mm3
- A haemoglobin count more than 9.0 g/dL
- Serum creatinine less than 1.5-fold the upper limit value of the normal range
- Bilirubin less than 1.5-fold the upper limit value of the normal range
- Activities of aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) less than 1.5-fold the upper limit value of normal range (if related to liver metastases less than 2.5-fold the upper limit value of the normal range)
- Saturation pulse oxygen (SpO2) level not less than 90%
- No participation in other clinical trials within 4 weeks before start of therapy within this trial
- Written informed consent given that is consistent with ICH-GCP guidelines
Who cannot join
- Brain tumour, and/or brain metastases requiring therapy
- History of obvious pulmonary fibrosis or interstitial pneumonitis in chest X-ray including pneumoconiosis or radiation-induced pulmonary fibrosis expanding out of radiation field
- Patients with difficulty in swallowing study medication
- Gastrointestinal disorders that might interfere with the absorption of the study drug (Crohn's disease, ulcerative colitis, broad resection of the stomach)
- Patients with diarrhoea greater than CTCAE grade 2
- Patients within 4 weeks after major surgical procedures or patients with active ulcers or with injuries with incomplete wound healing
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- History of autoimmune disease
- History of serious drug hypersensitivity
- History of cardiac infarction or congested heart failure of New York Heart Association Classification (NYHA) II or greater within previous 6 months
- Serious illness or concomitant non-oncological disease difficult to be controled by medication, such as active infectious disease, hepatic failure, renal failure, pulmonary fibrosis, interstitial pneumonitis, hemorrhagic tendency, heart disease (congested heart failure, angina, arrhythmia, etc.), uncontrolled, severe hypertension, and diabetes
- Pregnancy or breastfeeding
- Women and men who are sexually active and unwilling to use a medically acceptable method of contraception until 4 weeks after the last trial visit
- Patients positive in tests of hepatitis B (HBs) antigen, hepatitis C (HCV)antibody, or HIV antibody
- Alcohol or drug abuse
- Patient not suitable for participation in this clinical trial in the opinion of the investigator
About this study
Official title: A Phase I Open-label Dose-escalation Study of Continuous Twice-daily Oral Treatment With BIBF 1120 in Japanese Patients With Advanced Solid Tumours
Confirmation of BIBF 1120 administered from 150 mg twice daily (b.i.d.) to 250 mg b.i.d. as safe and tolerable treatment in Japanese patients with advanced solid tumours, overall safety, pharmacokinetic parameters, biomarkers, and efficacy of BIBF 1120.
- Conditions
- Tumors
- Being tested
- BIBF 1120
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBF 1120Drug
| Study group | Role | What they receive |
|---|---|---|
| BIBF 1120 | Experimental | Not described Receives: Drug: BIBF 1120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLT) associated with increasing doses of BIBF 1120
Measured: Up to 36 months
Incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTCAE Version 3.0) associated with increasing doses of BIBF 1120
Measured: up to 36 months
Secondary outcomes (28)
maximum tolerated dose (MTD) of BIBF 1120
Measured: Up to 36 months
Objective tumour response according to the response evaluation criteria in solid tumours (RECIST)
Measured: Up to 36 months
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 hours after single dose administration (AUC0-12)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the first drug administration
Change from baseline in peripheral blood biomarkers
Measured: Baseline, day 2, day 8, day 30
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24hours after single dose administration (AUC0-24)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable analyte plasma concentration after single dose administration (AUC0-tz)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration (AUC0-∞)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
The percentage of the AUCtz-∞ that is obtained by extrapolation (%AUCtz-∞)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Maximum measured concentration of the analyte in plasma following a single dose (Cmax)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Time from dosing to the maximum concentration of the analyte in plasma following a single dose (tmax)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Terminal half-life of the analyte in plasma after single dose administration (t1/2)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Terminal rate constant in plasma after single dose administration (λz)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Mean residence time of the analyte in the body after single dose oral administration (MRTpo)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Apparent clearance of the analyte in plasma after single dose extravascular administration (CL/F)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Area under the concentration-time curve of the analyte in plasma at steady state over the time interval from 0 to 24hours (AUC0-24,ss)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Τime from last dosing to the maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (tmax,ss)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Terminal rate constant in plasma at steady state (λz,ss)
Measured: Up to 36 month
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Average concentration of the analyte in plasma at steady state (Cavg)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss)
Measured: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Accumulation ratio (RA)
Measured: Up to 36 month
Predose concentration of the analyte in plasma immediately before administration of the n-th dose (Cpre,n)
Measured: Day 8, 15 and day 22 after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJun 2006
- Primary completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies 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
- 24 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
- NCT02182128
- Sponsor's protocol ID
- 1199.19
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label Dose-escalation Study of Continuous Twice-daily Oral Treatment With BIBF 1120 in Japanese Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT02182128
- Acronym / sponsor ID
- 1199.19
- Conditions
- Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jun 2009 (actual)
- First posted
- 8 Jul 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.
Confirmation of BIBF 1120 administered from 150 mg twice daily (b.i.d.) to 250 mg b.i.d. as safe and tolerable treatment in Japanese patients with advanced solid tumours, overall safety, pharmacokinetic parameters, biomarkers, and efficacy of BIBF 1120.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIBF 1120 | Experimental | Drug: BIBF 1120 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male or female patients with a confirmed diagnosis of an advanced, non resectable and/or metastatic solid tumour (except for malignant lymphoma)
- Patients who have not responded to conventional treatment, or for whom no therapy of proven efficacy was available, or who were not amenable to established forms of treatment
- Patients recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radio-therapies (except for epilation) at least over the following periods of time:
- Age 20 years or older
- Life expectancy of at least 3 months
Key exclusion criteria (15 listed)
- Brain tumour, and/or brain metastases requiring therapy
- History of obvious pulmonary fibrosis or interstitial pneumonitis in chest X-ray including pneumoconiosis or radiation-induced pulmonary fibrosis expanding out of radiation field
- Patients with difficulty in swallowing study medication
- Gastrointestinal disorders that might interfere with the absorption of the study drug (Crohn's disease, ulcerative colitis, broad resection of the stomach)
- Patients with diarrhoea greater than CTCAE grade 2
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 |
|---|---|---|
| BIBF 1120 | Drug | BIBF 1120 |
Primary outcome
Incidence of Dose Limiting Toxicities (DLT) associated with increasing doses of BIBF 1120
Time frame: Up to 36 months
Incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTCAE Version 3.0) associated with increasing doses of BIBF 1120
Time frame: up to 36 months
28 secondary outcomes
maximum tolerated dose (MTD) of BIBF 1120
Time frame: Up to 36 months
Objective tumour response according to the response evaluation criteria in solid tumours (RECIST)
Time frame: Up to 36 months
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 hours after single dose administration (AUC0-12)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the first drug administration
Change from baseline in peripheral blood biomarkers
Time frame: Baseline, day 2, day 8, day 30
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24hours after single dose administration (AUC0-24)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable analyte plasma concentration after single dose administration (AUC0-tz)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration (AUC0-∞)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
The percentage of the AUCtz-∞ that is obtained by extrapolation (%AUCtz-∞)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Maximum measured concentration of the analyte in plasma following a single dose (Cmax)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Time from dosing to the maximum concentration of the analyte in plasma following a single dose (tmax)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Terminal half-life of the analyte in plasma after single dose administration (t1/2)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Terminal rate constant in plasma after single dose administration (λz)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Mean residence time of the analyte in the body after single dose oral administration (MRTpo)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Apparent clearance of the analyte in plasma after single dose extravascular administration (CL/F)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Area under the concentration-time curve of the analyte in plasma at steady state over the time interval from 0 to 24hours (AUC0-24,ss)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Τime from last dosing to the maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (tmax,ss)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Terminal rate constant in plasma at steady state (λz,ss)
Time frame: Up to 36 month
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Average concentration of the analyte in plasma at steady state (Cavg)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss)
Time frame: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Accumulation ratio (RA)
Time frame: Up to 36 month
Predose concentration of the analyte in plasma immediately before administration of the n-th dose (Cpre,n)
Time frame: Day 8, 15 and day 22 after start of treatment
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 18 Jul 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 BIBF 1120 in people with Tumors, 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 21 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 18 Jul 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?
Incidence of Dose Limiting Toxicities (DLT) associated with increasing doses of BIBF 1120 (time frame: Up to 36 months). 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 18 Jul 2014.