Registrationsdatum der Studie
05.09.2016
Einschluss der ersten teilnehmenden Person
01.08.2016
Rekrutierungsstatus
Recruiting
Wissenschaftlicher Titel (Datenquelle: WHO)
An Open-label Phase 1/2a Study of BAL101553 Administered as Intravenous 48-hour Infusions in Adult Patients With Advanced Solid Tumors
Studientyp (Datenquelle: WHO)
Interventional
Design der Studie (Datenquelle: WHO)
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase (Datenquelle: WHO)
Phase 1/Phase 2
Primäre Endpunkte (Datenquelle: WHO)
To determine the maximum tolerated dose and characterize dose limiting toxicities of BAL101553 based on the number of participants with adverse effects as measure of tolerability at various dose levels
Sekundäre Endpunkte (Datenquelle: WHO)
To evaluate safety and tolerability of BAL101553 treatment based on the number of participants with adverse events at various dose levels;To evaluate safety and tolerability of BAL101553 treatment based on the number of participants with safety laboratory changes versus baseline;To evaluate safety and tolerability of BAL101553 treatment based on the number of participants with ECG changes versus baseline;BAL101553 and BAL27862 pharmacokinetics (PK);BAL101553 and BAL27862 pharmacokinetics (PK);BAL101553 and BAL27862 pharmacokinetics (PK);BAL101553 and BAL27862 pharmacokinetics (PK);BAL101553 and BAL27862 pharmacokinetics (PK);To assess the anti-tumor activity of BAL101553;To assess the bioavailability of daily oral BAL101553;Exploratory assessment of baseline levels and change from baseline of circulating tumor cells and other biomarkers to characterize pharmacodynamic effects of daily oral BAL101553;Exploratory assessment of baseline levels and change from baseline of circulating tumor cells and other biomarkers in blood and/or tumor tissue for potential utility as predictive biomarkers.
Kontakt für Auskünfte (Datenquelle: WHO)
Please refer to primary and secondary sponsors