The main purpose of the dose escalation phase of the study is to determine the safety of different doses of OMX-0407. The dose expansion (phase Ib) part of the study will evaluate efficacy, safety and tolerability at a dose determined in the dose escalation,
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
188
Dose escalation, Dose expansion
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Identify Dose Limiting Toxicities
Incidence of dose limiting toxicities at each dose level
Time frame: 4 weeks (1 cycle)
Identify objective response rate
Number of objective responses of OMX-0407 in patients with Renal Cell cancer, Non small cell lung cancer, urothelial cancer and angiosarcoma
Time frame: Every 12 weeks (3 cycles)
Maximum Tolerated Dose
Identify the maximum tolerated dose and recommended dose for Phase II based on toxicities at each dose level
Time frame: evaluated up to approximately 3 years
Investigate the safety and tolerability of OMX-0407
Incidence and severity of adverse events at each dose level
Time frame: through study completion, estimated up to approximately 3 years
Pharmacokinetics (Cmax) of OMX-0407
Maximum observed plasma concentration
Time frame: evaluated up to approximately 3 years
Pharmacokinetics (Tmax) of OMX-0407
Time of maximum observed plasma concentration
Time frame: evaluated up to approximately 3 years
Pharmacokinetics (AUClast) of OMX-0407
Area under the plasma concentration-time curve from time of dosing to the last quantifiable timepoint
Time frame: evaluated up to approximately 3 years
Pharmacokinetics (AUCinf) of OMX-0407
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitair Ziekenhuis Gent
Ghent, Belgium
CHU de Liège
Liège, Belgium
ZAS Augustinus Afdeling Oncologische Research
Wilrijk, Belgium
UNICANCER-Institut Bergonie - Nouvelle-Aquitaine
Bordeaux, France
Universite de Lyon - Centre Leon-Berard (CLB)
Lyon, France
Assistance Publique Hopitaux de Marseille- Hopital de La Timone
Marseille, France
Institut du Cancer Montpellier (ICM)
Montpellier, France
Institut de Cancerologie de Ouest (ICO) - Saint-Herblain
Nantes, France
UNICANCER - Centre Oscar Lambret
Nantes, France
...and 14 more locations
Area under the plasma concentration-time curve from time of dosing to infinity
Time frame: evaluated up to approximately 3 years
Pharmacokinetics (% extrapolated-AUCinf) of OMX-0407
The percentage of AUCinf derived via extrapolation from Tlast
Time frame: evaluated up to approximately 3 years
Pharmacokinetics (t½) of OMX-0407
Terminal elimination half-life
Time frame: evaluated up to approximately 3 years
Measure Duration of Response
Determine the median duration of response according to RECIST 1.1
Time frame: every 12 weeks (3 cycles)
Measure Progression Free Survivial
Determine the median time for progression free survival
Time frame: every 12 weeks (3 cycles)
Measure Overall Response Rates
Determine the overall number of responses
Time frame: every 12 weeks (3 cycles)
Measure Overall Survival
Determine the survival times of patients
Time frame: every 12 weeks (3 cycles)
Assess Quality of Life
Determine changes in quality of life
Time frame: Every 4 weeks (1 cycle)