An Dose Escalation Study of Treatment With BIBF 1120 in Patients With Advanced Solid Tumours

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Tumors

Treatments

Drug: BIBF 1120

Study type

Interventional

Funder types

Industry

Identifiers

NCT02182206

1199.3

Details and patient eligibility

About

Maximum Tolerated Dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120, pharmacodynamic parameters (Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI))

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients with confirmed diagnosis of advanced, non resectable and/or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who were not amenable to established forms of treatment
Measurable tumour deposits by one or more techniques (X-ray), Computed Tomography (CT), Magnetic Resonance Imaging (MRI))
At least one tumour lesion considered suitable for DCE-MRI as determined by discussion with centre radiologist. This lesion must not have been previously irradiated
Age 18 years or older
Life expectancy of at least three months
Written informed consent given consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines
Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
Patients completely recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies

Exclusion criteria

Surgical procedures within four weeks of initiating treatment with the study drug, active ulcers, or injuries with incomplete wound healing
Active infectious disease
Uncontrolled, severe hypertension (diastolic BP (Blood Pressure) >100 mmHg, Systolic BP>180 mmHg)
Gastrointestinal disorders that might have interfered with the resorption of the study drug
Serious illness or concomitant non-oncological disease considered by the investigator to have been incompatible with the protocol
Brain metastases requiring therapy
Absolute neutrophil count less than 1500/mm3
Platelet count less than 100 000/mm3
Bilirubin greater than 1.5 mg/dl (>26 μmol/L, System International (SI) unit equivalent)
Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
Serum creatinine greater than 1.5 mg/dl (>132μmol/L, SI unit equivalent)
Women and men who were sexually active and unwilling to use a medically acceptable method of contraception
Pregnancy or breastfeeding
Treatment with other investigational drugs; chemotherapy or hormone therapy (excluding Lutenizing Hormone Releasing Hormone (LHRH) agonists or bisphosphonates provided the lesion for MR (magnetic resonance) imaging did not arise from bone) or participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
Patients unable to comply with the protocol
Active alcohol or drug abuse
History of autoimmune disease
History of allergy to gadolinium or other intravenous (IV) contrast agent, indwelling medical devices or any other condition that would preclude MR scanning
Patients requiring the ongoing use of dexamethasone, anti-histamines, anti-hypertensives or medications for the control of cardiac failure such as diuretics, where there was likely to be a need for alteration of dose during the study period. Dose adjustment of such medications may have independently altered vascular permeability or blood flow