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Prostatic NeoplasmsPhase 2NCT02182063

A Study With BIBF 1120 in Patients With Hormone Refractory Prostate Cancer

A Phase 2 study testing BIBF 1120 low dose and BIBF 1120 high dose 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 aim of this study was to evaluate the efficacy of two different doses of BIBF 1120 (250 mg twice daily versus 150 mg twice daily) in an exploratory manner. Safety, quality of life and pharmacokinetic parameters on a sub-sample of 20 patients were also analysed for the two different doses. 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 low dose and BIBF 1120 high dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
No sites listed yet
Study dates
Nov 2005to Jan 2007
Phase
Phase 2
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

  • Patient written informed consent obtained prior to any study procedures and consistent with ICH-GCP (International Conference on Harmonization - Good Clinical Practice) guidelines and local law
  • Presence of histologically documented adenocarcinoma of the prostate
  • Presence of metastatic disease
  • Life expectancy of at least 3 months
  • Progression after orchidectomy or during LH-RH (Luteinising hormone - releasing hormone) analogs with castrate testosterone serum levels <30 ng/ml (chemical castration had to be continued) and absence of anti-androgen withdrawal syndrome
  • Minimum value of PSA = 20 ng/ml at screening
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  • Stopping the previous treatment with docetaxel based regimen or/and with antiandrogen 4 weeks before the inclusion of the patient
  • ECOG performance status ≤ 2
  • Progression after only one previous chemotherapy with docetaxel based regimen:
  • Appearance of a new lesion or increase of an existing measurable / non measurable lesion
  • Increase of PSA ≥ 25% documented by two successive exams
  • Increase of pain if there is a correlation with a radiological progression or with a PSA increase as defined above
  • Adequate hepatic function: total bilirubin within normal limits, ALT (Alanine aminotransferase) and/or AST (aspartate aminotransferase) ≤ 1.5x upper limit of normal (ULN). Prothrombin time (PT) and partial thromboplastin time (PTT): maximum 50% deviation from normal limits
  • Adequate renal function: serum creatinine ≤ 2 x upper normal limit (UNL)
  • Absolute neutrophil count (ANC) ≥ 1500/mL, Platelets ≥ 100,000/mL, Hemoglobin ≥ 9.0 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors)

Who cannot join

  • Gastrointestinal disorders or abnormalities that would inhibit absorption of the study drug
  • Serious illness or concomitant non-oncological disease such as neurologic-, psychiatric-, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study
  • Significant cardiovascular diseases (i.e. uncontrolled hypertension, instable angina, history of myocardial infarction or congestive heart failure >NYHA II (New York Heart Association) during the 6 previous months
  • Strontium or equivalent radioactive isotope during the 6 previous months
  • Concomitant second malignancy, with the exception of treated basal cell carcinoma of the skin or a recovered cancer at least since 5 years
  • Major injuries and surgeries within the past 4 weeks. Planned surgical procedures during the trial. Patients with incomplete wound healing
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  • History of haemorrhagic or emerging thrombotic event. Known inherited predisposition to hemorrhage or thrombosis
  • Patients who require full-dose anticoagulation or heparinization or continuous treatment with acetylsalicyclic acid > 325 mg
  • Concomitant treatment with other experimental drugs or anti-cancer therapy including hormone therapy (except LH-RH agonists)
  • Biphosphonates during the study since four weeks prior to the inclusion of the patient
  • Known or suspected symptomatic brain metastases
  • Known or suspected symptomatic epiduritis
  • Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy (visit 2) or concomitantly with this trial
  • Patients unable to comply with the protocol

About this study

Official title: An Open Label Randomized Phase II Study of Oral Treatment With BIBF 1120 250 mg Twice Daily Versus 150 mg Twice Daily in Patients Suffering From Hormone Refractory Prostate Cancer After Progression With Docetaxel Based Regimen

The aim of this study was to evaluate the efficacy of two different doses of BIBF 1120 (250 mg twice daily versus 150 mg twice daily) in an exploratory manner. Safety, quality of life and pharmacokinetic parameters on a sub-sample of 20 patients were also analysed for the two different doses.

Being tested
BIBF 1120 low dose, BIBF 1120 high dose
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 1120 low doseDrug

  • BIBF 1120 high doseDrug

Study groups in NCT02182063
Study groupRoleWhat they receive
BIBF 1120 low doseExperimentalNot described
Receives: Drug: BIBF 1120 low dose
BIBF 1120 high doseExperimentalNot described
Receives: Drug: BIBF 1120 high dose

What is being measured

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

  1. Decline of prostate specific antigen (PSA) of ≥20%

    Measured: Up to week 25 after first drug administration

Secondary outcomes (10)

  1. Decline of prostate specific antigen (PSA) of ≥50%

    Measured: Up to week 25 after first drug administration

  2. Time to Tumour Progression (TTP)

    Measured: Up to week 29

  3. Incidence and intensity of Adverse Events

    Measured: Up to week 34

  4. Radiological response rate according RECIST (Response Evaluation Criteria in Solid Tumours)

    Measured: Up to week 25 after first drug administration

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

    Measured: Baseline, up to week 25

  6. Duration of overall survival

    Measured: Up to week 29 after first drug administration

  7. Change in Prostate Specific Antigen Doubling Time (PSADT)

    Measured: Baseline, up to week 25

  8. Drug plasma concentration measurement

    Measured: Up to week 23 after first drug administration

  9. Change in Quality of Life (QoL) using the general questionnaire of the European Organization for Research and Treatment-Quality of Life Questionnaire (EORTC-QLQ-C30)

    Measured: Baseline, up to week 25

  10. Change in Pain Present Intensity (PPI) score

    Measured: Baseline, up to week 25

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 startNov 2005
  3. Primary completionJan 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02182063
Sponsor's protocol ID
1199.11
Status last verified
Dec 2017
First submitted
2 Jul 2014
Last updated
28 Dec 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIBF 1120 low dose and BIBF 1120 high dose 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 15 inclusion and 14 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 28 Dec 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Decline of prostate specific antigen (PSA) of ≥20% (time frame: Up to week 25 after first drug administration). 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 NCT02182063.

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 28 Dec 2017.

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