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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

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT02182141

First Posted

July 2, 2014

Last Updated

July 17, 2014

Sponsor

Boehringer Ingelheim

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

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

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An Dose Escalation Study of BIBF 1120 Administered in Patients With Relapsed or Refractory Multiple Myeloma

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