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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02182141
• Collaborator: (none)
• Enrollment: 17
• Arm: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: BIBF 1120 ES	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Apr 1, 2003
• Actual Primary Completion Date: Mar 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BIBF 1120	Drug: BIBF 1120 ES

Outcome Measures

Primary Outcome Measures

1. Maximum tolerated dose (MTD) [Up to 11 months]

Secondary Outcome Measures

1. Incidence and intensity of adverse events according to Common Toxicity Criteria (CTC) associated with increasing doses of BIBF 1120 [Up to 11 months]

2. Change from baseline in laboratory parameters [Baseline, up to 11 months]

3. Objective tumor response in surrogate markers [Baseline, up to 11 month]

4. Concentration at 2h (C2,1) [2 hours after first administration]

5. Change from baseline in cellular protein tyrosine kinase inhibition [Baseline, up to 11 months]

6. Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance score [Baseline, up to 11 months]

7. Change in vital signs [up to 11 months]

8. Change from baseline in electrocardiogram (ECG) [Baseline, up to 11 months]

9. Predose concentration immediately before administration of the Nth dose over the dosing interval τ (Cpre,N) [Up to day 28]

10. Area under the plasma concentration-time curve during the dosing interval τ (24 h) at steady state (AUCτ,ss) [Up to 11 months]

11. Plasma concentration at the time point immediately before dosing at steady state (Cpre,ss) [Up to 11 months]

12. Minimum plasma concentration during the dosing interval τ at steady state (Cmin,ss) [Up to 11 months]

13. Maximum plasma concentration during the dosing interval τ at steady state (Cmax,ss) [Up to 11 months]

14. Time to reach minimum plasma concentration during the dosing interval τ at steady state (tmin,ss) [Up to 11 months]

15. Time to reach maximum plasma concentration during the dosing interval τ at steady state (tmax,ss) [Up to 11 months]

16. Terminal half-life at steady state (t1/2,ss) [Up to 11 months]

17. Apparent plasma clearance at steady state (CL/F,ss) [Up to 11 months]

18. Mean residence time at steady state (MRTpo,ss) [Up to 11 months]

19. Apparent volume of distribution during the terminal phase at steady state (Vz/F,ss) [Up to 11 months]

20. Tumor response assessed according to the European Group for Blood and Marrow Transplantation (EBMT) criteria [Up to 11 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02182141
• Other Study ID Numbers: 1199.2
• First Posted: Jul 8, 2014
• Last Update Posted: Jul 18, 2014
• Last Verified: Jul 1, 2014

• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Nintedanib

Study Results

No Results Posted as of Jul 18, 2014