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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02182063
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : December 28, 2017
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: BIBF 1120 low dose Drug: BIBF 1120 high dose Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2005
Actual Primary Completion Date : January 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BIBF 1120 low dose Drug: BIBF 1120 low dose
Experimental: BIBF 1120 high dose Drug: BIBF 1120 high dose

Primary Outcome Measures :
  1. Decline of prostate specific antigen (PSA) of ≥20% [ Time Frame: Up to week 25 after first drug administration ]

Secondary Outcome Measures :
  1. Decline of prostate specific antigen (PSA) of ≥50% [ Time Frame: Up to week 25 after first drug administration ]
  2. Time to Tumour Progression (TTP) [ Time Frame: Up to week 29 ]
  3. Incidence and intensity of Adverse Events [ Time Frame: Up to week 34 ]
  4. Radiological response rate according RECIST (Response Evaluation Criteria in Solid Tumours) [ Time Frame: Up to week 25 after first drug administration ]
  5. Change in Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: Baseline, up to week 25 ]
  6. Duration of overall survival [ Time Frame: Up to week 29 after first drug administration ]
  7. Change in Prostate Specific Antigen Doubling Time (PSADT) [ Time Frame: Baseline, up to week 25 ]
  8. Drug plasma concentration measurement [ Time Frame: 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) [ Time Frame: Baseline, up to week 25 ]
  10. Change in Pain Present Intensity (PPI) score [ Time Frame: Baseline, up to week 25 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02182063    
Other Study ID Numbers: 1199.11
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action