Status:
COMPLETED
Dose Finding Study of BI 6727 (Volasertib) in Patients With Various Solid Cancers
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 in Asian cancer patients, and to provide safety data in terms of drug-related adverse events.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with histologically or cytologically confirmed diagnosis of advanced solid cancer
- Age 18 years or older
- Written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance score 2 or less
- Exclusion criteria:
- Serious illness or concomitant non-oncological disease.
- Pregnancy or breast feeding
- Active infectious disease
- Absolute neutrophil count less than 1,500/cubic millimeter
- Platelet count less than 100,000/cubic millimeter
- Bilirubin greater than 1.5 mg/dL (\> 26 µmol/L, SI unit equivalent)
- Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal
- Serum creatinine greater than 1.5x ULN.
Exclusion
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00969553
Start Date
August 1 2009
End Date
September 1 2011
Last Update
July 26 2019
Active Locations (2)
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1
1230.16.886002 Boehringer Ingelheim Investigational Site
Tainan, Taiwan
2
1230.16.886001 Boehringer Ingelheim Investigational Site
Taipei, Taiwan