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TumorsPhase 1NCT02182206

An Dose Escalation Study of Treatment With BIBF 1120 in Patients With Advanced Solid Tumours

A Phase 1 study testing BIBF 1120 in people with Tumors, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Maximum Tolerated Dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120, pharmacodynamic parameters (Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)) Read more about this study

Who is it for?
Ages 18 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
50 participants
Where
No sites listed yet
Study dates
Jun 2003to Jun 2005
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

  • Male or female 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 were not amenable to established forms of treatment
  • Measurable tumour deposits by one or more techniques (X-ray), Computed Tomography (CT), Magnetic Resonance Imaging (MRI))
  • At least one tumour lesion considered suitable for DCE-MRI as determined by discussion with centre radiologist. This lesion must not have been previously irradiated
  • Age 18 years or older
  • Life expectancy of at least three months
  • Written informed consent given consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines
  • Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
  • Patients completely recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies

Who cannot join

  • Surgical procedures within four weeks of initiating treatment with the study drug, active ulcers, or injuries with incomplete wound healing
  • Active infectious disease
  • Uncontrolled, severe hypertension (diastolic BP (Blood Pressure) >100 mmHg, Systolic BP>180 mmHg)
  • Gastrointestinal disorders that might have interfered with the resorption of the study drug
  • Serious illness or concomitant non-oncological disease considered by the investigator to have been incompatible with the protocol
  • Brain metastases requiring therapy
Show all 19Show fewer
  • Absolute neutrophil count less than 1500/mm3
  • Platelet count less than 100 000/mm3
  • Bilirubin greater than 1.5 mg/dl (>26 μmol/L, System International (SI) unit equivalent)
  • Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three 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 (>132μmol/L, SI unit equivalent)
  • Women and men who were sexually active and unwilling to use a medically acceptable method of contraception
  • Pregnancy or breastfeeding
  • Treatment with other investigational drugs; chemotherapy or hormone therapy (excluding Lutenizing Hormone Releasing Hormone (LHRH) agonists or bisphosphonates provided the lesion for MR (magnetic resonance) imaging did not arise from bone) or participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
  • Patients unable to comply with the protocol
  • Active alcohol or drug abuse
  • History of autoimmune disease
  • History of allergy to gadolinium or other intravenous (IV) contrast agent, indwelling medical devices or any other condition that would preclude MR scanning
  • Patients requiring the ongoing use of dexamethasone, anti-histamines, anti-hypertensives or medications for the control of cardiac failure such as diuretics, where there was likely to be a need for alteration of dose during the study period. Dose adjustment of such medications may have independently altered vascular permeability or blood flow

About this study

Official title: A Phase I Open Label Dose Escalation Study of Continuous Once-daily or Twice Daily Oral Treatment With BIBF 1120 in Patients With Advanced Solid Tumours

Maximum Tolerated Dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120, pharmacodynamic parameters (Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI))

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 groups in NCT02182206
Study groupRoleWhat they receive
BIBF 1120ExperimentalNot described
Receives: Drug: BIBF 1120

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD) of BIBF 1120

    Measured: Up to 7 months

  2. Incidence and intensity of Adverse Events according to common toxicity criteria (CTC) associated with increasing doses of BIBF 1120

    Measured: Up to 7 months

Secondary outcomes (35)

  1. Transfer constant (Ktrans)

    Measured: Screening, day 2, 28 and 56

  2. Extravascular-extracellular leakage volume (ve)

    Measured: Screening, day 2, 28 and 56

  3. Area under the gadolinium concentration time curve [0-60 seconds] (AUC[Gd])

    Measured: Screening, day 2, 28 and 56

  4. Relative blood volume (rBV)

    Measured: Screening, day 2, 28 and 56

  5. Mean transit time (MTT)

    Measured: Screening, day 2, 28 and 56

  6. Relative blood flow (rBF)

    Measured: Screening, day 2, 28 and 56

  7. Volume of tumour showing contrast uptake

    Measured: Screening, day 2, 28 and 56

  8. Volume of tumour showing no contrast uptake

    Measured: Screening, day 2, 28 and 56

  9. Restricted diffusion

    Measured: Screening, day 2, 28 and 56

  10. Vessel size index

    Measured: Screening, day 2, 28 and 56

  11. Change in Eastern Cooperative Oncology Group (ECOG) performance score

    Measured: Baseline, up to 7 months

  12. Objective tumour responses according to the response evaluation criteria in solid tumour (RECIST)

    Measured: Baseline, up to 7 months

  13. Area under the plasma concentration-time curve following the first dose of uniform intervals τ over the time interval from zero to 24 hours (AUCτ,1)

    Measured: up to 24 hours after the first dose on day 1

  14. Area under the plasma concentration-time curve over the time interval from zero to the time of the last quantifiable drug concentration (AUC0-tz)

    Measured: up to 24 hours after the first dose on day 1

  15. Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC0-∞)

    Measured: up to 24 hours after the first dose on day 1

  16. Maximum measured plasma concentration following the first dose of uniform intervals τ (Cmax,1)

    Measured: up to 24 hours after the first dose on day 1

  17. Time from dosing to the maximum plasma concentration following the first dose of uniform intervals τ (tmax,1)

    Measured: up to 24 hours after the first dose on day 1

  18. Terminal half-life (t1/2)

    Measured: up to 24 hours after the first dose on day 1

  19. Mean residence time (MRTpo)

    Measured: up to 24 hours after the first dose on day 1

  20. Apparent clearance (CL/F)

    Measured: up to 24 hours after the first dose on day 1

  21. Apparent volume of distribution during the terminal phase (Vz/F)

    Measured: up to 24 hours after the first dose on day 1

  22. Area under the plasma concentration-time curve over the dosing interval τ (24 h) at steady state (AUCτ,ss)

    Measured: up to 24 hours after drug administration on day 27

  23. Predose plasma concentration at steady state immediately before dosing (Cpre,ss)

    Measured: up to 24 hours after drug administration on day 27

  24. Maximum plasma concentration at steady state over the dosing interval τ (Cmax,ss)

    Measured: up to 24 hours after drug administration on day 27

  25. Time from dosing to the maximum plasma concentration at steady state over the dosing interval τ (tmax,ss)

    Measured: up to 24 hours after drug administration on day 27

  26. Terminal half-life at steady state (t1/2,ss)

    Measured: up to 24 hours after drug administration on day 27

  27. Apparent clearance at steady state (CL/F,ss)

    Measured: up to 24 hours after drug administration on day 27

  28. Mean residence time at steady state (MRTpo,ss),

    Measured: up to 24 hours after drug administration on day 27

  29. Apparent volume of distribution during the terminal phase at steady state (Vz/F,ss)

    Measured: up to 24 hours after drug administration on day 27

  30. Accumulation ratio (RA)

    Measured: up to 24 hours after drug administration on day 27

  31. Minimum measured plasma concentration following the first dose of uniform intervals τ (Cmin,1)

    Measured: up to 24 hours after the first dose on day 1

  32. Time from first dosing to the minimum plasma concentration over the dosing interval τ (tmin,1)

    Measured: up to 24 hours after the first dose on day 1

  33. Minimum measured plasma concentration at steady state over the dosing interval τ (Cmin,ss)

    Measured: up to 24 hours after drug administration on day 27

  34. Time from last dosing to the minimum plasma concentration at steady state over the dosing interval τ (tmin,ss)

    Measured: up to 24 hours after drug administration on day 27

  35. Predose concentration of the 15th dose over the dosing interval τ (Cpre,15)

    Measured: pre-dose on day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2014 (estimated)
  2. Study startJun 2003
  3. Primary completionJun 2005

Resources

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02182206
Sponsor's protocol ID
1199.3
Status last verified
Jul 2014
First submitted
2 Jul 2014
Last updated
18 Jul 2014
Results posted
No

Publications

  • Lee CP, Taylor NJ, Attard G, Pacey S, Nathan PD, de Bono JS, Temple G, Bell S, Stefanic M, Stopfer P, Tang A, Koh DM, Collins DJ, d'Arcy J, Padhani AR, Leach MO, Judson IR, Rustin GJ. Phase I study of nintedanib incorporating dynamic contrast-enhanced magnetic resonance imaging in patients with advanced solid tumors. Oncologist. 2015 Apr;20(4):368-9. doi: 10.1634/theoncologist.2014-0250. Epub 2015 Mar 20.

    PubMed 25795637

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 8 inclusion and 19 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?

Maximum Tolerated Dose (MTD) of BIBF 1120 (time frame: Up to 7 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?

On the ClinicalTrials.gov record for NCT02182206, 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 18 Jul 2014.

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