Status:
COMPLETED
BI 6727 Administered Intravenously Every 3 Weeks in Patients With Solid Tumours
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events. Secondary objectives are the collection of overall safet...
Eligibility Criteria
Inclusion
- 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 forms of treatment
- Age 18 years or older
- Written informed consent consistent with ICH-GCP and local legislation
- Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score ¿ 2
- Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies (except alopecia)
- The 18 additional patients recruited at the MTD must also meet the following criterion:
- Measurable tumour deposits (RECIST) by one or more techniques (CT, MRI)
- Exclusion criteria:
- Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
- Pregnancy or breastfeeding
- Active infectious disease or known chronic Hepatitis B/Hepatitis C infection
- Clinical evidence of active brain or leptomeningeal disease during the past 12 months
- Second malignancy currently requiring active therapy
- Absolute neutrophil count less than 1500 / mm3
- Platelet count less than 100 000 / mm3
- Bilirubin greater than 1.5 mg / dl (\> 26 ¿mol / 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 ¿mol / L, SI unit equivalent)
- Known history of relevant QT-prolongation, e.g. long QT-syndrome
- Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
- Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
- Chemo-, radio or immunotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.
- Patients unable to comply with the protocol
- Active alcohol or drug abuse
Exclusion
Key Trial Info
Start Date :
November 4 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2021
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT02273388
Start Date
November 4 2005
End Date
April 6 2021
Last Update
October 3 2023
Active Locations (2)
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1
1230.1.32002 Boehringer Ingelheim Investigational Site
Brussels, Belgium
2
1230.1.32001 Boehringer Ingelheim Investigational Site
Leuven, Belgium