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

An Open Label Dose Escalation Study of BIBF 1120 Administered Orally for Four Weeks in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit

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.

Study Overview

• Status: Completed
• Conditions: Malignant Solid Tumour
• Intervention / Treatment: Drug: BIBF 1120

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Freiburg, Germany, 79106
    • Klinik für Tumorbiologie, Abteilung Internistische Onkologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIBF 1120	Drug: BIBF 1120

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum tolerated dose of BIBF 1120	up to 30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall best investigator assessment of tumour response	up to 4 months
Overall best calculated assessment of tumour response	up to 4 months
Time to tumour progression	up to 4 months
Change in Eastern Cooperative Oncology Group (ECOG) score	up to 4 months
Number of patients with response in transfer of contrast medium into tissue (Ktrans)	up to 4 months
Number of patients with response in initial area under the curve for first 60 seconds after onset of gadolinium uptake (iAUC60)	60 seconds
Mean plasma level of vascular endothelial growth factor (VEGF)	10 hours after drug intake
Mean plasma level of basic fibroblast growth factor (bFGF)	10 hours after drug intake

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (Actual): November 1, 2004

Study Registration Dates

• First Submitted: September 17, 2013
• First Submitted That Met QC Criteria: September 24, 2013
• First Posted (Estimate): September 27, 2013

Study Record Updates

• Last Update Posted (Estimate): September 27, 2013
• Last Update Submitted That Met QC Criteria: September 24, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Nintedanib
• Other Study ID Numbers: 1199.1