Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Treatment With BIBF 1120 Together With Docetaxel and Prednisone 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.
 
ClinicalTrials.gov Identifier: NCT02182219
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 18, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: BIBF 1120 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2005
Actual Primary Completion Date : April 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIBF 1120 Drug: BIBF 1120



Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: 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 [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Area under the plasma concentration-time curve (AUC) over the dosing interval τ following the first dose (AUC0-24) [ Time Frame: up to 336 hours after drug administration ]
  2. Incidence of prostate specific antigen (PSA) decline ≥ 50% from the baseline value [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, day 15 of cycle 3 and at the end of cycle 6 ]
  5. Change in Eastern Cooperative Oncology Group (ECOG) performance score [ Time Frame: 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 [ Time Frame: up to 336 hours after drug administration ]
  7. AUC over the time interval from zero extrapolated to infinity (AUC0-∞) after the first dose [ Time Frame: up to 336 hours after drug administration ]
  8. Percentage of AUC0-∞ obtained by extrapolation (%AUCtz-∞) [ Time Frame: up to 336 hours after drug administration ]
  9. Maximum measured plasma concentration (Cmax) following the first dose [ Time Frame: up to 336 hours after drug administration ]
  10. Time from dosing to the maximum plasma concentration (tmax) following the first dose [ Time Frame: up to 336 hours after drug administration ]
  11. Terminal rate constant in plasma (λz ) [ Time Frame: up to 336 hours after drug administration ]
  12. Terminal half-life (t1/2) [ Time Frame: up to 336 hours after drug administration ]
  13. Mean residence time (MRTpo) after oral administration [ Time Frame: up to 336 hours after drug administration ]
  14. Apparent clearance (CL/F) [ Time Frame: up to 336 hours after drug administration ]
  15. Apparent volume of distribution during the terminal phase (Vz/F) [ Time Frame: up to 336 hours after drug administration ]
  16. Pre-dose plasma concentration immediately before administration [ Time Frame: Days 2, 3, 8 and 15 ]
  17. Plasma concentration at 24 hours following the first (C24,1) dose [ Time Frame: 24 hours after administration ]
  18. Mean residence time (MRTiv) after i.v. administration [ Time Frame: up to 336 hours after drug administration ]
  19. Clearance (CL) after i.v. administration [ Time Frame: up to 336 hours after drug administration ]
  20. Apparent volume of distribution during the terminal phase (Vz) after i.v. administration [ Time Frame: up to 336 hours after drug administration ]
  21. Apparent volume of distribution at steady state (Vss) [ Time Frame: up to 336 hours after drug administration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically-proven metastatic prostate adenocarcinoma
  2. Progression after hormonal therapy
  3. 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)
  4. Life expectancy of at least three months
  5. ECOG performance status ≤ 2
  6. 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.

Exclusion Criteria:

  1. Prior treatment for hormone refractory prostate cancer (HRPC) including chemotherapy, biologic response modifier therapy, or any investigational drug
  2. Participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
  3. Major injuries and surgeries within the past 4 weeks. Planned surgical procedures during the trial
  4. Brain metastases
  5. Radiotherapy superior to 30% of the medullar volume
  6. Other malignancy diagnosed within the past 5 years (other than non-melanomatous skin cancer)
  7. 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
  8. Previous history of stroke, angor pectoris, ischemic cardiomyopathy, cerebral ischemia, arteritis in the past 6 months
  9. Recent history of hemorrhagic or evolutive thrombotic event (including transient ischemic attacks) in the past 6 months
  10. Patients who require full-dose anticoagulation or heparinization
  11. Absolute neutrophil count (ANC) < 1,500/μl, platelet count < 100,000/μl, or hemoglobin < 8 mg/dL
  12. Total bilirubin > upper limit of normal (ULN); alanine amino transferase (ALT) and/or aspartate amino transferase (AST) >1.5 X ULN
  13. Serum creatinine > 1.5 mg/dL (> 132 μ mole/L, SI Unit equivalent)
  14. Known or suspected active alcohol or drug abuse
  15. Patients unable to comply with the protocol

Additional Information:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182219    
Other Study ID Numbers: 1199.4
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Nintedanib
Hormones
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Antineoplastic Agents, Hormonal
Enzyme Inhibitors