Phase I Study of BI 831266 in Patients With Advanced Solid Tumours

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00756223
First received: September 19, 2008
Last updated: November 20, 2013
Last verified: November 2013

September 19, 2008
November 20, 2013
November 2008
October 2010   (final data collection date for primary outcome measure)
Maximum tolerated dose [ Time Frame: 3-4 weeks ] [ Designated as safety issue: Yes ]
Maximum tolerated dose [ Time Frame: 3-4 weeks ]
Complete list of historical versions of study NCT00756223 on ClinicalTrials.gov Archive Site
  • Safety parameters (incidence and intensity of AEs graded according to the common terminology criteria for AEs and incidence of DLT) [ Time Frame: throughout the study period ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameters [ Time Frame: throughout the study period ] [ Designated as safety issue: No ]
  • Pharmacodynamic analysis [ Time Frame: 3-4 weeks ] [ Designated as safety issue: No ]
  • Efficacy data (progression free survival, objective response rate, response duration) [ Time Frame: throughout the study period ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
Phase I Study of BI 831266 in Patients With Advanced Solid Tumours
An Open-label Phase I Single Dose Escalation Trial of Two Dosing Schedules of BI 831266 Administered Intravenously Over 24 h Continuously in Patients With Advanced Solid Tumours

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
  • Drug: Arm A
    Dose escalation Arm A (4 weeks)
  • Drug: Arm B
    Dose escalation Arm B (3 weeks)
  • Experimental: Arm A
    BI 831266 24h infusion on day 1 and day 15 every 4 weeks
    Intervention: Drug: Arm A
  • Experimental: Arm B
    BI 831266 24h infusion on day 1 every 3 weeks
    Intervention: Drug: Arm B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
Not Provided
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00756223
1257.1, 2008-001631-36
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP