- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02182063
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
81
Phase
- 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
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
- 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)
Exclusion Criteria:
- 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
- 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
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 |
Intervention / Treatment |
---|---|
Experimental: BIBF 1120 low dose
|
|
Experimental: BIBF 1120 high dose
|
What is the study measuring?
Primary Outcome Measures
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
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
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
November 1, 2005
Primary Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
July 2, 2014
First Submitted That Met QC Criteria
July 7, 2014
First Posted (Estimate)
July 8, 2014
Study Record Updates
Last Update Posted (Actual)
December 28, 2017
Last Update Submitted That Met QC Criteria
December 27, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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