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

NCT01951846 | Completed Phase 1

• 1 other identifier: 1199.1
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of BIBF 1120

  up to 30 days

Secondary Outcomes (8)

• 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

Study Arms (1)

BIBF 1120

EXPERIMENTAL

Drug: BIBF 1120

Interventions

BIBF 1120 DRUG

BIBF 1120

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Klinik für Tumorbiologie, Abteilung Internistische Onkologie

Freiburg im Breisgau, 79106, Germany

Location

MeSH Terms

Interventions

nintedanib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: September 27, 2013
• Study Start: November 1, 2002
• Primary Completion: November 1, 2004
• Last Updated: September 27, 2013

Record last verified: 2013-09

Locations

DE (1)