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Phase I Study of BI 831266 in Patients With Advanced Solid Tumours
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, April 2009
First Received: September 19, 2008   Last Updated: April 23, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00756223
  Purpose

The main objective of this trial is to provide safety data in terms of drug-related adverse events for the recommendation of the dose for further trials in the development of BI 831266. Secondary objectives are the collection of antitumour efficacy data and the determination of the pharmacokinetic and pharmacodynamic profile of BI 831266.


Condition Intervention Phase
Neoplasms
Drug: BI 831266
Phase I

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: Phase I Dose Escalation Trial in Patients With Advanced Solid Tumors

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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 and incidence of DLT, pharmacokinetic parameters, pharmacodynamic analysis, progression free survival, objective response rate, response duration [ Time Frame: throughout the study period ]

Estimated Enrollment: 50
Study Start Date: November 2008
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with confirmed diagnosis of advanced, non-resectable and/or metastatic solid malignant tumours, who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options
  2. Secure central venous access
  3. Measurable and/or non-measurable tumour deposits
  4. Recovery from toxicities of prior anti-cancer therapies at least to CTCAE grade 1
  5. Age >= 18 years
  6. Life expectancy >= 3 months
  7. Written informed consent in accordance with International Conference on Harmonisation guideline for Good Clinical Practice and local legislation
  8. Eastern Cooperative Oncology Group performance score <= 2

Exclusion Criteria:

  1. 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
  2. Pregnancy or breastfeeding
  3. Symptomatic brain metastases and/or leptomeningeal disease requiring therapy
  4. Second malignancy requiring therapy
  5. Left ventricular ejection fraction (LVEF) < 50% in echocardiography
  6. Clinically significant (i.e. active) cardiovascular disease: CVA/stroke (<= 6 months prior to randomisation), myocardial infarction (<= 6 months prior to randomisation), unstable angina, New York Heart Association Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
  7. Absolute neutrophil count less than 1500 / mm3
  8. Platelet count less than 100 000 / mm3
  9. Bilirubin greater than 1.5 mg / dl (> 26 micromol / L, SI unit equivalent)
  10. 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)
  11. Serum creatinine greater than 1.5 mg / dl (> 132 micromol / L, SI unit equivalent)
  12. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
  13. Treatment with other investigational drugs or in another clinical trial within the past two weeks before start of therapy or concomitantly with this trial
  14. Chemo-, hormone, radio- or immunotherapy within the past two weeks before start of therapy or concomitantly with this trial
  15. Patients unable to comply with the protocol
  16. Active alcohol or drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756223

Contacts
Contact: Boehringer Ingelheim Study Coordinator 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Austria
1257.1.4301 Boehringer Ingelheim Investigational Site Recruiting
Wien, Austria
1257.1.4302 Boehringer Ingelheim Investigational Site Recruiting
Salzburg, Austria
1257.1.4303 Boehringer Ingelheim Investigational Site Recruiting
Linz, Austria
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1257.1, EudraCT No.: 2008-001631-36
Study First Received: September 19, 2008
Last Updated: April 23, 2009
ClinicalTrials.gov Identifier: NCT00756223     History of Changes
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009