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Prostatic NeoplasmsPhase 1NCT02182219

Oral Treatment With BIBF 1120 Together With Docetaxel and Prednisone in Patients With Hormone Refractory Prostate Cancer

A Phase 1 study testing BIBF 1120 in people with Prostatic Neoplasms, 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

The primary objective of this study was to determine the safety and Maximum tolerated dose (MTD) of BIBF 1120 combination therapy with docetaxel and prednisone in patients with hormone refractory prostate cancer. Read more about this study

Who is it for?
Any age, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
BIBF 1120
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
No sites listed yet
Study dates
1 Nov 2005to 1 Apr 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 Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with histologically-proven metastatic prostate adenocarcinoma
  • Progression after hormonal therapy
  • Progressive disease as follows:
  • Increase of PSA > 5 ng/ml on two occasions despite castrate levels of testosterone before screening
  • AND/OR Progressive measurable disease (RECIST criteria)
  • AND/OR Progressive bone metastases (presence of new lesion(s) on a bone scan)
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  • Life expectancy of at least three months
  • ECOG performance status ≤ 2
  • Patient written informed consent obtained prior to any trial procedures and that is consistent with ICH-GCP (International Conference on Harmonization - Good Clinical Practice) guidelines.

Who cannot join

  • Prior treatment for hormone refractory prostate cancer (HRPC) including chemotherapy, biologic response modifier therapy, or any investigational drug
  • Participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
  • Major injuries and surgeries within the past 4 weeks. Planned surgical procedures during the trial
  • Brain metastases
  • Radiotherapy superior to 30% of the medullar volume
  • Other malignancy diagnosed within the past 5 years (other than non-melanomatous skin cancer)
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  • Gastrointestinal abnormalities that would interfere with intake or absorption of the study drug, such as a requirement for intravenous alimentation, prior surgical procedures affecting absorption, treatment for peptic ulcer disease within the last 6 months, active gastrointestinal bleeding unrelated to cancer (as evidenced by either hematemesis, or melena in the past 3 months and without endoscopic documented resolution), or malabsorption syndromes
  • Previous history of stroke, angor pectoris, ischemic cardiomyopathy, cerebral ischemia, arteritis in the past 6 months
  • Recent history of hemorrhagic or evolutive thrombotic event (including transient ischemic attacks) in the past 6 months
  • Patients who require full-dose anticoagulation or heparinization
  • Absolute neutrophil count (ANC) < 1,500/μl, platelet count < 100,000/μl, or hemoglobin < 8 mg/dL
  • Total bilirubin > upper limit of normal (ULN); alanine amino transferase (ALT) and/or aspartate amino transferase (AST) >1.5 X ULN
  • Serum creatinine > 1.5 mg/dL (> 132 μ mole/L, SI Unit equivalent)
  • Known or suspected active alcohol or drug abuse
  • Patients unable to comply with the protocol

About this study

Official title: A Phase I Open Label Dose Escalation Study of Continuous (Except on the Days of Chemotherapy Infusion) Oral Treatment With BIBF 1120 Together With Docetaxel and Prednisone in Patients With Hormone Refractory Prostate Cancer

The primary objective of this study was to determine the safety and Maximum tolerated dose (MTD) of BIBF 1120 combination therapy with docetaxel and prednisone in patients with hormone refractory prostate cancer. Secondary objectives were to characterise the pharmacokinetic profiles of BIBF 1120 and docetaxel and possible Pharmacokinetic (PK) interactions between BIBF 1120 and docetaxel and to obtain preliminary information on anti-tumour activity.

Being tested
BIBF 1120
Medical subject headings
Prostatic 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 NCT02182219
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)

    Measured: Up to day 126

  2. Incidence and intensity of Adverse Events according to the Common Terminology Criteria for Adverse Events (version 3.0) associated with increasing doses of BIBF 1120

    Measured: up to 6 months

Secondary outcomes (21)

  1. Area under the plasma concentration-time curve (AUC) over the dosing interval τ following the first dose (AUC0-24)

    Measured: up to 336 hours after drug administration

  2. Incidence of prostate specific antigen (PSA) decline ≥ 50% from the baseline value

    Measured: Baseline, up to day 126

  3. Number of patients with an objective tumour response (Partial Response (PR), Complete Response (CR)) according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria

    Measured: Baseline, day 15 of cycle 3 and at the end of cycle 6

  4. Number of patients without signs of tumour progression (stable disease (SD)) according to RECIST criteria

    Measured: Baseline, day 15 of cycle 3 and at the end of cycle 6

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

    Measured: Baseline, up to day 156

  6. AUC over the time interval from zero to the time of the last quantifiable drug concentration after the first dose (AUC0-tz) within the dosing interval τ

    Measured: up to 336 hours after drug administration

  7. AUC over the time interval from zero extrapolated to infinity (AUC0-∞) after the first dose

    Measured: up to 336 hours after drug administration

  8. Percentage of AUC0-∞ obtained by extrapolation (%AUCtz-∞)

    Measured: up to 336 hours after drug administration

  9. Maximum measured plasma concentration (Cmax) following the first dose

    Measured: up to 336 hours after drug administration

  10. Time from dosing to the maximum plasma concentration (tmax) following the first dose

    Measured: up to 336 hours after drug administration

  11. Terminal rate constant in plasma (λz )

    Measured: up to 336 hours after drug administration

  12. Terminal half-life (t1/2)

    Measured: up to 336 hours after drug administration

  13. Mean residence time (MRTpo) after oral administration

    Measured: up to 336 hours after drug administration

  14. Apparent clearance (CL/F)

    Measured: up to 336 hours after drug administration

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

    Measured: up to 336 hours after drug administration

  16. Pre-dose plasma concentration immediately before administration

    Measured: Days 2, 3, 8 and 15

  17. Plasma concentration at 24 hours following the first (C24,1) dose

    Measured: 24 hours after administration

  18. Mean residence time (MRTiv) after i.v. administration

    Measured: up to 336 hours after drug administration

  19. Clearance (CL) after i.v. administration

    Measured: up to 336 hours after drug administration

  20. Apparent volume of distribution during the terminal phase (Vz) after i.v. administration

    Measured: up to 336 hours after drug administration

  21. Apparent volume of distribution at steady state (Vss)

    Measured: up to 336 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.

  1. First posted8 Jul 2014 (estimated)
  2. Study start1 Nov 2005
  3. Primary completion1 Apr 2007

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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02182219
Sponsor's protocol ID
1199.4
Status last verified
Jan 2025
First submitted
2 Jul 2014
Last updated
22 Jan 2025
Results posted
No
Individual data sharing
No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIBF 1120 in people with Prostatic 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 9 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 22 Jan 2025. 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) (time frame: Up to day 126). 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 NCT02182219.

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 22 Jan 2025.

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