BI 2536 BS in Patients With Advanced Solid Tumours and Repeated Administration in Patients With Clinical Benefit

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: BI 2536 BS, intravenous

Study type

Interventional

Funder types

Industry

Identifiers

NCT02211872

1216.1

Details and patient eligibility

About

The primary objective of this study was to determine the maximum tolerated dose (MTD) of BI 2536 BS in patients with advanced solid tumours. Secondary objectives were the evaluation of safety, efficacy, and pharmacokinetics of BI 2536 BS

Enrollment

63 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who had failed conventional treatment, or for whom no therapy of proven efficacy exists, or who were not amenable to established forms of treatment
Evaluable tumour deposits
Age of 18 years or older
Life expectancy of at least 6 months
Written informed consent consistent with international conference of harmonization (ICH) - good clinical practice (GCP) and local legislation
Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score ≤ 2
And full recovery from all therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies

Exclusion criteria

Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the trial protocol
Pregnancy or breastfeeding
Active infectious disease
Known brain metastases
Second malignancy 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, international system of units (SI) equivalent)
Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 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 (> 132 μmol/L, SI unit equivalent)
Sexually active women and men who are unwilling to use a medically acceptable method of contraception
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)
Chemo-, radio or immunotherapy within the past four weeks before start of therapy or concomitantly with this trial
Patients unable to comply with the trial protocol
Or active alcohol or drug abuse