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BI 811283 in Various Solid Tumours

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00701324
First Posted: June 19, 2008
Last Update Posted: July 22, 2014
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.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose

The main objective of this trial is to provide safety data in terms of drug-related adverse events (AE) for the recommendation of the dose for further trials in the development of BI 811283.

Secondary objectives are the collection of antitumour efficacy data and the determination of the pharmacokinetic profile of BI 811283.


Condition Intervention Phase
Neoplasms Drug: BI 811283 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Phase I Single Dose Escalation Study of Two Dosing Schedules of BI 811283 Administered Intravenously Over 24 h Continuous Infusion in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: 3-4 weeks ]

Secondary Outcome Measures:
  • Safety profile: incidence and intensity of AEs graded according to the common terminology criteria for AEs, incidence of DLT [ Time Frame: throughout the study period ]
  • Progression free survival (PFS), Objective response, Response duration, Pharmacodynamic analysis, Basic pharmacokinetics [ Time Frame: throughout the study period ]

Enrollment: 124
Study Start Date: June 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
BI 811283, 24h infusion d1 and d15 every 4 weeks
Drug: BI 811283
dose escalation BI 811283, Arm A (day 1)
Drug: BI 811283
dose escalation BI 811283, Arm A (day 15)
Experimental: Arm B
BI 811283, 24h infusion d1 every 3 weeks
Drug: BI 811283
dose escalation BI 811283, Arm B (3 weeks)

  Eligibility

Information from the National Library of Medicine

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

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 treatment options Secure central venous access Evaluable tumour deposits Recovery from reversible toxicities of prior anti-cancer therapies Age >= 18 years Life expectancy >= 6 months Written informed consent in accordance with International Conference on Harmonisation (ICH) guideline for Good Clinical Practice (GCP) and local legislation Eastern Cooperative Oncology Group performance score <= 2

Exclusion criteria:

Serious illness, concomitant non-oncological disease (e.g. active infectious disease), or ongoing toxicity of prior therapies considered by the investigator to potentially compromise patients' safety in this trial Pregnancy or breastfeeding Known brain metastases Second malignancy requiring therapy Left ventricular ejection fraction (LVEF) < 50% in echocardiography or clinical congestive heart failure New York Heart Association grade III - IV Myocardial infarction within the last 6 months prior to inclusion or symptomatic coronary artery disease Absolute neutrophil count less than 1500 / mm3 Platelet count less than 100 000 / mm3 Bilirubin greater than 1.5 mg / dl (> 26 mcmol / L, SI unit equivalent) Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 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 mcmol / L, SI unit equivalent) Women and men who are sexually active and unwilling to use a medically acceptable method of contraception Treatment with other investigational drugs or in another clinical trial within the past two weeks before start of therapy or concomitantly with this trial Chemo-, hormone, radio- or immunotherapy within the past two weeks before start of therapy or concomitantly with this trial Patients unable to comply with the protocol Active alcohol or drug abuse

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00701324


Locations
Germany
1247.1.49002 Boehringer Ingelheim Investigational Site
Essen, Germany
1247.1.49001 Boehringer Ingelheim Investigational Site
Freiburg/Breisgau, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00701324     History of Changes
Other Study ID Numbers: 1247.1
2007-000191-17 ( EudraCT Number: EudraCT )
First Submitted: June 18, 2008
First Posted: June 19, 2008
Last Update Posted: July 22, 2014
Last Verified: July 2014