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

Primary Purpose

Prostatic Neoplasms

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

BIBF 1120

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIBF 1120

Arm Description

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD)

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

Secondary Outcome Measures

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

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

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

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

Change in Eastern Cooperative Oncology Group (ECOG) performance score

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

AUC over the time interval from zero extrapolated to infinity (AUC0-∞) after the first dose

Percentage of AUC0-∞ obtained by extrapolation (%AUCtz-∞)

Maximum measured plasma concentration (Cmax) following the first dose

Time from dosing to the maximum plasma concentration (tmax) following the first dose

Terminal rate constant in plasma (λz )

Terminal half-life (t1/2)

Mean residence time (MRTpo) after oral administration

Apparent clearance (CL/F)

Apparent volume of distribution during the terminal phase (Vz/F)

Pre-dose plasma concentration immediately before administration

Plasma concentration at 24 hours following the first (C24,1) dose

Mean residence time (MRTiv) after i.v. administration

Clearance (CL) after i.v. administration

Apparent volume of distribution during the terminal phase (Vz) after i.v. administration

Apparent volume of distribution at steady state (Vss)

Full Information

NCT ID

NCT02182219

First Posted

July 2, 2014

Last Updated

July 17, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02182219

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

November 2005 (undefined)

Primary Completion Date

April 2007 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BIBF 1120

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

BIBF 1120

Primary Outcome Measure Information:

Title

Maximum Tolerated Dose (MTD)

Time Frame

Up to day 126

Title

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 Measure Information:

Title

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

Title

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

Time Frame

Baseline, up to day 126

Title

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

Title

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

Title

Change in Eastern Cooperative Oncology Group (ECOG) performance score

Time Frame

Baseline, up to day 156

Title

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

Title

AUC over the time interval from zero extrapolated to infinity (AUC0-∞) after the first dose

Time Frame

up to 336 hours after drug administration

Title

Percentage of AUC0-∞ obtained by extrapolation (%AUCtz-∞)

Time Frame

up to 336 hours after drug administration

Title

Maximum measured plasma concentration (Cmax) following the first dose

Time Frame

up to 336 hours after drug administration

Title

Time from dosing to the maximum plasma concentration (tmax) following the first dose

Time Frame

up to 336 hours after drug administration

Title

Terminal rate constant in plasma (λz )

Time Frame

up to 336 hours after drug administration

Title

Terminal half-life (t1/2)

Time Frame

up to 336 hours after drug administration

Title

Mean residence time (MRTpo) after oral administration

Time Frame

up to 336 hours after drug administration

Title

Apparent clearance (CL/F)

Time Frame

up to 336 hours after drug administration

Title

Apparent volume of distribution during the terminal phase (Vz/F)

Time Frame

up to 336 hours after drug administration

Title

Pre-dose plasma concentration immediately before administration

Time Frame

Days 2, 3, 8 and 15

Title

Plasma concentration at 24 hours following the first (C24,1) dose

Time Frame

24 hours after administration

Title

Mean residence time (MRTiv) after i.v. administration

Time Frame

up to 336 hours after drug administration

Title

Clearance (CL) after i.v. administration

Time Frame

up to 336 hours after drug administration

Title

Apparent volume of distribution during the terminal phase (Vz) after i.v. administration

Time Frame

up to 336 hours after drug administration

Title

Apparent volume of distribution at steady state (Vss)

Time Frame

up to 336 hours after drug administration

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com

Description

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

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