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

Malignant Solid Tumour Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951846
• Other study ID #: 1199.1
• Status: Completed
• Phase: Phase 1
• First received: September 17, 2013
• Last updated: September 24, 2013
• Start date: November 2002

Study information

• Verified date: September 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Malignant Solid Tumour
• Neoplasms

Intervention

Drug:
• BIBF 1120

Locations

Country	Name	City	State
Germany	Klinik für Tumorbiologie, Abteilung Internistische Onkologie	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of BIBF 1120		up to 30 days	Yes
Secondary	Overall best investigator assessment of tumour response		up to 4 months	No
Secondary	Overall best calculated assessment of tumour response		up to 4 months	No
Secondary	Time to tumour progression		up to 4 months	No
Secondary	Change in Eastern Cooperative Oncology Group (ECOG) score		up to 4 months	No
Secondary	Number of patients with response in transfer of contrast medium into tissue (Ktrans)		up to 4 months	No
Secondary	Number of patients with response in initial area under the curve for first 60 seconds after onset of gadolinium uptake (iAUC60)		60 seconds	No
Secondary	Mean plasma level of vascular endothelial growth factor (VEGF)		10 hours after drug intake	No
Secondary	Mean plasma level of basic fibroblast growth factor (bFGF)		10 hours after drug intake	No