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
  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: Arm A
Drug: Arm B
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: 3-4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: November 2008
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
BI 831266 24h infusion on day 1 and day 15 every 4 weeks
Drug: Arm A
Dose escalation Arm A (4 weeks)
Experimental: Arm B
BI 831266 24h infusion on day 1 every 3 weeks
Drug: Arm B
Dose escalation Arm B (3 weeks)

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756223

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

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00756223     History of Changes
Other Study ID Numbers: 1257.1, 2008-001631-36
Study First Received: September 19, 2008
Last Updated: November 20, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014