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

December 27, 2017 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. 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
  2. Presence of histologically documented adenocarcinoma of the prostate
  3. Presence of metastatic disease
  4. Life expectancy of at least 3 months
  5. 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
  6. Minimum value of PSA = 20 ng/ml at screening
  7. Stopping the previous treatment with docetaxel based regimen or/and with antiandrogen 4 weeks before the inclusion of the patient
  8. ECOG performance status ≤ 2

  9. 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
  10. 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
  11. Adequate renal function: serum creatinine ≤ 2 x upper normal limit (UNL)
  12. 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)

Exclusion Criteria:

  1. Gastrointestinal disorders or abnormalities that would inhibit absorption of the study drug
  2. 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
  3. 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
  4. Strontium or equivalent radioactive isotope during the 6 previous months
  5. Concomitant second malignancy, with the exception of treated basal cell carcinoma of the skin or a recovered cancer at least since 5 years
  6. Major injuries and surgeries within the past 4 weeks. Planned surgical procedures during the trial. Patients with incomplete wound healing
  7. History of haemorrhagic or emerging thrombotic event. Known inherited predisposition to hemorrhage or thrombosis
  8. Patients who require full-dose anticoagulation or heparinization or continuous treatment with acetylsalicyclic acid > 325 mg
  9. Concomitant treatment with other experimental drugs or anti-cancer therapy including hormone therapy (except LH-RH agonists)
  10. Biphosphonates during the study since four weeks prior to the inclusion of the patient
  11. Known or suspected symptomatic brain metastases
  12. Known or suspected symptomatic epiduritis
  13. 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
  14. Patients unable to comply with the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BIBF 1120 low dose
Drug: BIBF 1120 low dose
Experimental: BIBF 1120 high dose
Drug: BIBF 1120 high dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Decline of prostate specific antigen (PSA) of ≥20%
Time Frame: Up to week 25 after first drug administration
Up to week 25 after first drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Decline of prostate specific antigen (PSA) of ≥50%
Time Frame: Up to week 25 after first drug administration
Up to week 25 after first drug administration
Time to Tumour Progression (TTP)
Time Frame: Up to week 29
Up to week 29
Incidence and intensity of Adverse Events
Time Frame: Up to week 34
Up to week 34
Radiological response rate according RECIST (Response Evaluation Criteria in Solid Tumours)
Time Frame: Up to week 25 after first drug administration
Up to week 25 after first drug administration
Change in Eastern Cooperative Oncology Group (ECOG) performance status
Time Frame: Baseline, up to week 25
Baseline, up to week 25
Duration of overall survival
Time Frame: Up to week 29 after first drug administration
Up to week 29 after first drug administration
Change in Prostate Specific Antigen Doubling Time (PSADT)
Time Frame: Baseline, up to week 25
Baseline, up to week 25
Drug plasma concentration measurement
Time Frame: Up to week 23 after first drug administration
Up to week 23 after first drug administration
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)
Time Frame: Baseline, up to week 25
Baseline, up to week 25
Change in Pain Present Intensity (PPI) score
Time Frame: Baseline, up to week 25
Baseline, up to week 25

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1199.11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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