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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02182141
• Other study ID #: 1199.2
• Status: Completed
• Phase: Phase 1
• First received: July 2, 2014
• Last updated: July 17, 2014
• Start date: April 2003

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120, pharmacodynamics

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Age 18 years or older

3. Life expectancy of at least six months

4. Patients have to give written informed consent (which must be consistent with ICH-GCP and local legislation)

5. Eastern Cooperative Oncology Group (ECOG) performance score <2.

6. Recovery from all therapy-related toxicities from previous chemo-, immuno- or radiotherapies.

Exclusion Criteria:

1. 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

2. Active infectious disease

3. Uncontrolled, severe hypertension

4. Gastrointestinal disorders anticipated to interfere with the resorption of the study drug

5. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol

6. Absolute neutrophil count less than 1000 / mm³.

7. Platelet count less than 30 000 / mm³

8. Conjugated Bilirubin greater than 2 mg / dl (> 34 µmol/L, SI unit equivalent)

9. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal

10. Endogenous creatinine clearance (ECC) <20 ml/min

11. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception

12. Pregnancy or breastfeeding

13. 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)

14. Patients unable to comply with the protocol

15. Active alcohol or drug abuse

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• BIBF 1120 ES

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD)		Up to 11 months	No
Secondary	Incidence and intensity of adverse events according to Common Toxicity Criteria (CTC) associated with increasing doses of BIBF 1120		Up to 11 months	No
Secondary	Change from baseline in laboratory parameters		Baseline, up to 11 months	No
Secondary	Objective tumor response in surrogate markers		Baseline, up to 11 month	No
Secondary	Concentration at 2h (C2,1)		2 hours after first administration	No
Secondary	Change from baseline in cellular protein tyrosine kinase inhibition		Baseline, up to 11 months	No
Secondary	Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance score		Baseline, up to 11 months	No
Secondary	Change in vital signs		up to 11 months	No
Secondary	Change from baseline in electrocardiogram (ECG)		Baseline, up to 11 months	No
Secondary	Predose concentration immediately before administration of the Nth dose over the dosing interval t (Cpre,N)		Up to day 28	No
Secondary	Area under the plasma concentration-time curve during the dosing interval t (24 h) at steady state (AUCt,ss)		Up to 11 months	No
Secondary	Plasma concentration at the time point immediately before dosing at steady state (Cpre,ss)		Up to 11 months	No
Secondary	Minimum plasma concentration during the dosing interval t at steady state (Cmin,ss)		Up to 11 months	No
Secondary	Maximum plasma concentration during the dosing interval t at steady state (Cmax,ss)		Up to 11 months	No
Secondary	Time to reach minimum plasma concentration during the dosing interval t at steady state (tmin,ss)		Up to 11 months	No
Secondary	Time to reach maximum plasma concentration during the dosing interval t at steady state (tmax,ss)		Up to 11 months	No
Secondary	Terminal half-life at steady state (t1/2,ss)		Up to 11 months	No
Secondary	Apparent plasma clearance at steady state (CL/F,ss)		Up to 11 months	No
Secondary	Mean residence time at steady state (MRTpo,ss)		Up to 11 months	No
Secondary	Apparent volume of distribution during the terminal phase at steady state (Vz/F,ss)		Up to 11 months	No
Secondary	Tumor response assessed according to the European Group for Blood and Marrow Transplantation (EBMT) criteria		Up to 11 months	No

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