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

NCT02182141 | Completed Phase 1

• 1 other identifier: 1199.2
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD)

  Up to 11 months

Secondary Outcomes (20)

• Incidence and intensity of adverse events according to Common Toxicity Criteria (CTC) associated with increasing doses of BIBF 1120

  Up to 11 months

• Change from baseline in laboratory parameters

  Baseline, up to 11 months

• Objective tumor response in surrogate markers

  Baseline, up to 11 month

• Concentration at 2h (C2,1)

  2 hours after first administration

• Change from baseline in cellular protein tyrosine kinase inhibition

  Baseline, up to 11 months

Study Arms (1)

BIBF 1120

EXPERIMENTAL

Drug: BIBF 1120 ES

Interventions

BIBF 1120 ES DRUG

BIBF 1120

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: April 1, 2003
• Primary Completion: March 1, 2005
• Last Updated: July 18, 2014

Record last verified: 2014-07