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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01951846
Recruitment Status : Completed
First Posted : September 27, 2013
Last Update Posted : September 27, 2013
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Malignant Solid Tumour Drug: BIBF 1120 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : November 2002
Actual Primary Completion Date : November 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BIBF 1120 Drug: BIBF 1120

Primary Outcome Measures :
  1. Maximum tolerated dose of BIBF 1120 [ Time Frame: up to 30 days ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01951846

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Klinik für Tumorbiologie, Abteilung Internistische Onkologie
Freiburg, Germany, 79106
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim Identifier: NCT01951846    
Other Study ID Numbers: 1199.1
First Posted: September 27, 2013    Key Record Dates
Last Update Posted: September 27, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action