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

NCT ID: NCT01951846

Last Updated: 2013-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30

Brief 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.

Conditions

Malignant Solid Tumour

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

BIBF 1120

Group Type: EXPERIMENTAL

BIBF 1120

Intervention Type: DRUG

Interventions

BIBF 1120

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Klinik für Tumorbiologie, Abteilung Internistische Onkologie

Freiburg im Breisgau, , Germany

Countries

Germany

Other Identifiers

1199.1

Identifier Type: -

Identifier Source: org_study_id