Status:
COMPLETED
Phase I Study of BI 831266 in Patients With Advanced Solid Tumours
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 obj...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Secure central venous access
- Measurable and/or non-measurable tumour deposits
- Recovery from toxicities of prior anti-cancer therapies at least to CTCAE grade 1
- Age \>= 18 years
- Life expectancy \>= 3 months
- Written informed consent in accordance with International Conference on Harmonisation guideline for Good Clinical Practice 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
- Symptomatic brain metastases and/or leptomeningeal disease requiring therapy
- Second malignancy requiring therapy
- Left ventricular ejection fraction (LVEF) \< 50% in echocardiography
- 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
- Absolute neutrophil count less than 1500 / mm3
- Platelet count less than 100 000 / mm3
- Bilirubin greater than 1.5 mg / dl (\> 26 micromol / 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 micromol / 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
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00756223
Start Date
November 1 2008
Last Update
November 21 2013
Active Locations (3)
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1
1257.1.4303 Boehringer Ingelheim Investigational Site
Linz, Austria
2
1257.1.4302 Boehringer Ingelheim Investigational Site
Salzburg, Austria
3
1257.1.4301 Boehringer Ingelheim Investigational Site
Vienna, Austria