Status:
COMPLETED
BI 6727 (Volasertib) in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumour
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 when combined with a platinum therapy (cisplatin or carbo...
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
- Indication for a treatment with platinum therapy as judged by the investigator
- Age 18 years or older
- Written informed consent consistent with ICH-GCP and local legislation
- ECOG performance score lower or equal 2
- Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous systemic anti-cancer therapies or radiotherapies (except alopecia grade 2)
- 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 and HIV I/II
- Clinical evidence of symptomatic progressive brain or leptomeningeal disease during the past 6 months
- Second malignancy currently requiring another anti-cancer therapy
- ANC less than 1500 / mm3
- Platelet count less than 100 000 / mm3
- Bilirubin greater than 1.5 mg / dl (\> 26 micromol / L, SI unit equivalent) (except Gilbert's syndrome)
- 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) or creatinine clearance \<70ml/min (as calculated according to Cockcroft-Gault formula for GFR estimate)
- Known history of relevant QT-prolongation, e.g. long QT-syndrome
- Pre-existing clinically relevant hearing loss
- 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 interventional trial within the past four weeks before start of therapy or concomitantly with this trial
- Systemic anti-cancer therapy or radiotherapy 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 :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00969761
Start Date
August 1 2009
End Date
February 1 2012
Last Update
January 31 2019
Active Locations (2)
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1
1230.6.3201 Boehringer Ingelheim Investigational Site
Brussels, Belgium
2
1230.6.3202 Boehringer Ingelheim Investigational Site
Leuven, Belgium