Oral Treatment With BIBF 1120 Together With Docetaxel and Prednisone in Patients With Hormone Refractory Prostate Cancer

NCT02182219 | Completed Phase 1

• 1 other identifier: 1199.4
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD)

  Up to day 126

• 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

  up to 6 months

Secondary Outcomes (21)

• Area under the plasma concentration-time curve (AUC) over the dosing interval τ following the first dose (AUC0-24)

  up to 336 hours after drug administration

• Incidence of prostate specific antigen (PSA) decline ≥ 50% from the baseline value

  Baseline, up to day 126

• Number of patients with an objective tumour response (Partial Response (PR), Complete Response (CR)) according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria

  Baseline, day 15 of cycle 3 and at the end of cycle 6

• Number of patients without signs of tumour progression (stable disease (SD)) according to RECIST criteria

  Baseline, day 15 of cycle 3 and at the end of cycle 6

• Change in Eastern Cooperative Oncology Group (ECOG) performance score

  Baseline, up to day 156

Study Arms (1)

BIBF 1120

EXPERIMENTAL

Drug: BIBF 1120

Interventions

BIBF 1120 DRUG

BIBF 1120

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Related Links

• Related Info

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: November 1, 2005
• Primary Completion: April 1, 2007
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share