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CompletedNCT02182128Updated Jul 18, 2014

A Dose-escalation Study of BIBF 1120 in Japanese Patients With Advanced Solid Tumours

A Phase 1 interventional study of BIBF 1120 in Tumors, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-07-18.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Tumors

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03

In context

Neoplasms

9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 24 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.

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Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.

Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female patients with a confirmed diagnosis of an advanced, non resectable and/or metastatic solid tumour (except for malignant lymphoma)
  2. 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

  3. 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)
    • two weeks after receiving immunotherapy
    • four weeks after surgical procedures
  4. Age 20 years or older
  5. Life expectancy of at least 3 months
  6. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2

  7. 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%
  8. No participation in other clinical trials within 4 weeks before start of therapy within this trial
  9. Written informed consent given that is consistent with ICH-GCP guidelines

Exclusion criteria

Exclusion criteria

  1. Brain tumour, and/or brain metastases requiring therapy
  2. History of obvious pulmonary fibrosis or interstitial pneumonitis in chest X-ray including pneumoconiosis or radiation-induced pulmonary fibrosis expanding out of radiation field
  3. Patients with difficulty in swallowing study medication
  4. Gastrointestinal disorders that might interfere with the absorption of the study drug (Crohn's disease, ulcerative colitis, broad resection of the stomach)
  5. Patients with diarrhoea greater than CTCAE grade 2
  6. Patients within 4 weeks after major surgical procedures or patients with active ulcers or with injuries with incomplete wound healing
  7. History of autoimmune disease
  8. History of serious drug hypersensitivity
  9. History of cardiac infarction or congested heart failure of New York Heart Association Classification (NYHA) II or greater within previous 6 months
  10. 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
  11. Pregnancy or breastfeeding
  12. 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
  13. Patients positive in tests of hepatitis B (HBs) antigen, hepatitis C (HCV)antibody, or HIV antibody
  14. Alcohol or drug abuse
  15. Patient not suitable for participation in this clinical trial in the opinion of the investigator
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    BIBF 1120

    Drug: BIBF 1120

Interventions

06

What researchers measure

Primary outcomes

  1. Incidence of Dose Limiting Toxicities (DLT) associated with increasing doses of BIBF 1120

    Time frame: Up to 36 months

  2. 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

Secondary outcomes

  1. maximum tolerated dose (MTD) of BIBF 1120

    Time frame: Up to 36 months

  2. Objective tumour response according to the response evaluation criteria in solid tumours (RECIST)

    Time frame: Up to 36 months

  3. 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

  4. Change from baseline in peripheral blood biomarkers

    Time frame: Baseline, day 2, day 8, day 30

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. Terminal rate constant in plasma at steady state (λz,ss)

    Time frame: Up to 36 month

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. Accumulation ratio (RA)

    Time frame: Up to 36 month

  28. 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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2006 and a primary completion of Jun 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 2, 2014
First posted
Jul 8, 2014
Start
Jun 2006
Primary completionActual
Jun 2009
Last update
Jul 18, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02182128
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jul 8, 2014
Start date
Jun 2006
Primary completion
Jun 2009
Last update
Jul 18, 2014
View the source record on ClinicalTrials.gov ↗

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