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Completed

NCT Number: NCT01951846

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

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.

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Key information

Conditions

Malignant Solid Tumour

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Klinik für Tumorbiologie, Abteilung Internistische Onkologie

Freiburg im Breisgau, 79106, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIBF 1120

Drug

Primary outcomes

  1. Maximum tolerated dose of BIBF 1120

    Time frame: up to 30 days

Secondary outcomes

  1. Overall best investigator assessment of tumour response

    Time frame: up to 4 months

  2. Overall best calculated assessment of tumour response

    Time frame: up to 4 months

  3. Time to tumour progression

    Time frame: up to 4 months

  4. Change in Eastern Cooperative Oncology Group (ECOG) score

    Time frame: up to 4 months

  5. Number of patients with response in transfer of contrast medium into tissue (Ktrans)

    Time frame: up to 4 months

  6. Number of patients with response in initial area under the curve for first 60 seconds after onset of gadolinium uptake (iAUC60)

    Time frame: 60 seconds

  7. Mean plasma level of vascular endothelial growth factor (VEGF)

    Time frame: 10 hours after drug intake

  8. Mean plasma level of basic fibroblast growth factor (bFGF)

    Time frame: 10 hours after drug intake

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2004
First posted
Sep 27, 2013
Registry last updated
Sep 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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