To Determine the Maximum Tolerated Dose (MTD) of BIBF 1120 in Patients With Solid Tumours

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study was to determine the maximum tolerated dose (MTD) of BIBF 1120 in patients with solid tumours by the monitoring of drug-related adverse events. Secondary objectives were the evaluation of safety, efficacy, pharmacokinetics, and pharmacodynamics.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Nintedanib

Criteria

Inclusion Criteria:

• 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 are not amenable to established forms of treatment

• Evaluable tumour deposits by one or more techniques (X-ray, CT, MRI, ultrasound)

• Age 18 years or older

• Life expectancy of at least three months

• Patients had to give written informed consent (which must be consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) and local legislation)

• Eastern Cooperative Oncology Group (ECOG) performance score < 2

• Full recovery from all therapy-related toxicities from previous chemo-, hormone-,immuno-, or radiotherapy

Exclusion Criteria:

• History of relevant surgical procedures during the last four weeks prior to treatment with the trial drug, or active ulcers, or injuries with incomplete wound healing

• Pregnancy or breastfeeding

• Active infectious disease

• 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, International System of Units (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 (> 132 μmol / L, SI unit equivalent)

• 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

• Women and men who are sexually active and 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)

• Patients unable to comply with the protocol

• Active alcohol or drug abuse