An Dose Escalation Study of BIBF 1120 Administered in Patients With Relapsed or Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BIBF 1120 ES
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Patients with confirmed diagnosis of multiple myeloma, who did not respond to or relapsed after either anthracyclines and pulsed glucocorticoids or high-dose therapy and who are currently not eligible for transplant modalities.
- Age 18 years or older
- Life expectancy of at least six months
- Patients have to give written informed consent (which must be consistent with ICH-GCP and local legislation)
- Eastern Cooperative Oncology Group (ECOG) performance score <2.
- Recovery from all therapy-related toxicities from previous chemo-, immuno- or radiotherapies.
Exclusion Criteria:
- History of relevant surgical procedures during the last four weeks prior to treatment with the trial drug, or active ulcers, fractures or injuries with incomplete healing
- Active infectious disease
- Uncontrolled, severe hypertension
- Gastrointestinal disorders anticipated to interfere with the resorption of the study drug
- Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
- Absolute neutrophil count less than 1000 / mm³.
- Platelet count less than 30 000 / mm³
- Conjugated Bilirubin greater than 2 mg / dl (> 34 μmol/L, SI unit equivalent)
- Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal
- Endogenous creatinine clearance (ECC) <20 ml/min
- Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
- Pregnancy or breastfeeding
- Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
- Patients unable to comply with the protocol
- Active alcohol or drug abuse
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)
Secondary Outcome Measures
Incidence and intensity of adverse events according to Common Toxicity Criteria (CTC) associated with increasing doses of BIBF 1120
Change from baseline in laboratory parameters
Objective tumor response in surrogate markers
Concentration at 2h (C2,1)
Change from baseline in cellular protein tyrosine kinase inhibition
Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance score
Change in vital signs
Change from baseline in electrocardiogram (ECG)
Predose concentration immediately before administration of the Nth dose over the dosing interval τ (Cpre,N)
Area under the plasma concentration-time curve during the dosing interval τ (24 h) at steady state (AUCτ,ss)
Plasma concentration at the time point immediately before dosing at steady state (Cpre,ss)
Minimum plasma concentration during the dosing interval τ at steady state (Cmin,ss)
Maximum plasma concentration during the dosing interval τ at steady state (Cmax,ss)
Time to reach minimum plasma concentration during the dosing interval τ at steady state (tmin,ss)
Time to reach maximum plasma concentration during the dosing interval τ at steady state (tmax,ss)
Terminal half-life at steady state (t1/2,ss)
Apparent plasma clearance at steady state (CL/F,ss)
Mean residence time at steady state (MRTpo,ss)
Apparent volume of distribution during the terminal phase at steady state (Vz/F,ss)
Tumor response assessed according to the European Group for Blood and Marrow Transplantation (EBMT) criteria
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02182141
Brief Title
An Dose Escalation Study of BIBF 1120 Administered in Patients With Relapsed or Refractory Multiple Myeloma
Official Title
An Open Label Dose Escalation Study of BIBF 1120 Administered Orally for Four Weeks in Patients With Relapsed or Refractory Multiple Myeloma With Repeated Administration in Patients With Clinical Benefit
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
March 2005 (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
Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120, pharmacodynamics
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIBF 1120
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BIBF 1120 ES
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD)
Time Frame
Up to 11 months
Secondary Outcome Measure Information:
Title
Incidence and intensity of adverse events according to Common Toxicity Criteria (CTC) associated with increasing doses of BIBF 1120
Time Frame
Up to 11 months
Title
Change from baseline in laboratory parameters
Time Frame
Baseline, up to 11 months
Title
Objective tumor response in surrogate markers
Time Frame
Baseline, up to 11 month
Title
Concentration at 2h (C2,1)
Time Frame
2 hours after first administration
Title
Change from baseline in cellular protein tyrosine kinase inhibition
Time Frame
Baseline, up to 11 months
Title
Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance score
Time Frame
Baseline, up to 11 months
Title
Change in vital signs
Time Frame
up to 11 months
Title
Change from baseline in electrocardiogram (ECG)
Time Frame
Baseline, up to 11 months
Title
Predose concentration immediately before administration of the Nth dose over the dosing interval τ (Cpre,N)
Time Frame
Up to day 28
Title
Area under the plasma concentration-time curve during the dosing interval τ (24 h) at steady state (AUCτ,ss)
Time Frame
Up to 11 months
Title
Plasma concentration at the time point immediately before dosing at steady state (Cpre,ss)
Time Frame
Up to 11 months
Title
Minimum plasma concentration during the dosing interval τ at steady state (Cmin,ss)
Time Frame
Up to 11 months
Title
Maximum plasma concentration during the dosing interval τ at steady state (Cmax,ss)
Time Frame
Up to 11 months
Title
Time to reach minimum plasma concentration during the dosing interval τ at steady state (tmin,ss)
Time Frame
Up to 11 months
Title
Time to reach maximum plasma concentration during the dosing interval τ at steady state (tmax,ss)
Time Frame
Up to 11 months
Title
Terminal half-life at steady state (t1/2,ss)
Time Frame
Up to 11 months
Title
Apparent plasma clearance at steady state (CL/F,ss)
Time Frame
Up to 11 months
Title
Mean residence time at steady state (MRTpo,ss)
Time Frame
Up to 11 months
Title
Apparent volume of distribution during the terminal phase at steady state (Vz/F,ss)
Time Frame
Up to 11 months
Title
Tumor response assessed according to the European Group for Blood and Marrow Transplantation (EBMT) criteria
Time Frame
Up to 11 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with confirmed diagnosis of multiple myeloma, who did not respond to or relapsed after either anthracyclines and pulsed glucocorticoids or high-dose therapy and who are currently not eligible for transplant modalities.
Age 18 years or older
Life expectancy of at least six months
Patients have to give written informed consent (which must be consistent with ICH-GCP and local legislation)
Eastern Cooperative Oncology Group (ECOG) performance score <2.
Recovery from all therapy-related toxicities from previous chemo-, immuno- or radiotherapies.
Exclusion Criteria:
History of relevant surgical procedures during the last four weeks prior to treatment with the trial drug, or active ulcers, fractures or injuries with incomplete healing
Active infectious disease
Uncontrolled, severe hypertension
Gastrointestinal disorders anticipated to interfere with the resorption of the study drug
Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
Absolute neutrophil count less than 1000 / mm³.
Platelet count less than 30 000 / mm³
Conjugated Bilirubin greater than 2 mg / dl (> 34 μmol/L, SI unit equivalent)
Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal
Endogenous creatinine clearance (ECC) <20 ml/min
Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
Pregnancy or breastfeeding
Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
Patients unable to comply with the protocol
Active alcohol or drug abuse
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info
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An Dose Escalation Study of BIBF 1120 Administered in Patients With Relapsed or Refractory Multiple Myeloma
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