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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: BIBF 1120 ES

Study type: Interventional

Funder types: Industry

Identifiers

NCT02182141

1199.2

Details and patient eligibility

About

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

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

17 participants in 1 patient group

BIBF 1120

Experimental group

Treatment:

Drug: BIBF 1120 ES