EMD Serono decided to terminate enrollment based on a review of the available clinical data and low probability of completing the trial based on the observed recruitment rate. Subjects already enrolled in the study continued participation in the study, consistent with the protocol, to study completion.
The goal of this research study is to investigate for the first time the safety and tolerability of a new drug (AS703569), called an aurora kinase inhibitor, being tested to treat blood cancers in patients with different blood cancers. The research study will also assess how the body breaks down AS703569 and what changes occur in the blood after oral doses of AS703569. It will also look to see if there is any improvement in your blood cancer. The use of AS703569 in this study is experimental.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Dose Escalation Regimen 1 - 3-47 mg/m2/day, orally once daily on days 1, 2,3 and 8, 9, 10 of a 21 day cycle: Number of cycles: until progression or unacceptable toxicity develops. Cohort Expansion Regimen 1 - Maximum tolerated dose from dose-escalation part or a lower dose in mg/m2/day, orally once daily on days 1, 2,3 and 8, 9, 10 of a 21 day cycle: Number of cycles: until progression or unacceptable toxicity develops
Dose Escalation Regimen 2 - 3-47 mg/m2/day, orally once daily on days 1, 2, 3, 4, 5, 6 of a 21 day cycle Number of cycles: until progression or unacceptable toxicity develops. Cohort Expansion Regimen 2 - Maximum tolerated dose from dose-escalation part or a lower dose in mg/m2/day, orally once daily on days 1, 2, 3, 4, 5, 6 of a 21 day cycle Number of cycles: until progression or unacceptable toxicity develops.
CTRC at the UT Health Science Center at San Antonio
San Antonio, Texas, United States
Haematologie UZ Gasthuisberg
Leuven, Belgium
Mont-Godinne University Hospital (UCL)
Yvoir, Belgium
Universitatsklinik Frankfurt
Dose-Limiting Toxicity (DLT)
Dose-escalation part - The number of subjects experiencing at least a Dose-Limiting Toxicity (DLT), judged to be related to the study medication, evaluated over the first cycle only for each dose level and regimen, independently.
Time frame: 21 days or 1 cycle
Preliminary anti-tumour activity
Cohort expansion part - Preliminary anti-tumour activity in four selected cohorts of haematological malignancies as assessed every two cycles
Time frame: 42 days or 2 cycles
Treatment-emergent adverse events (TEAE)
Dose-escalation and Cohort expansion parts The proportion/number of subjects experiencing treatment-emergent adverse events (TEAE) after the first cycle and during multiple cycles, in each cohort for each of the 2 dose-regimens.
Time frame: minimum 21 days or 1 cycle
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Frankfurt am Main, Germany
Technische Universitat Munchen
München, Germany
Medizinische Universitatsklinik
Ulm, Germany
Policlinico Sant'Orsola Malpighi
Bologna, Italy
Kantonsspital Basel
Basel, Switzerland
Hospitaux Universitaires
Geneva, Switzerland
Kantonsspital St Gallen
Sankt Gallen, Switzerland