« Projekte
A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients with Metastatic Pancreatic Adenocarcinoma
Projektleiter:
Finanzierung:
Fördergeber - Sonstige;
The primary objective of this study is to compare the OS of patients with metastatic pancreaticcarcinoma and low hENT1 expression treated with CO-1.01 and gemcitabine. The antitumorefficacy of CO-1.01 and gemcitabine in all patients with metastatic pancreatic carcinoma,irrespective of hENT1 status, will also be assessed and correlated with a biomarker (CA 19-9)changes over time. The toxicity of CO-1.01 will be compared with gemcitabine. Pain severity,health status, and pharmacogenetic biomarkers will be evaluated. Sparse sampling forpopulation PK analyses will also be conducted in all patients treated with CO-1.01. A positiveoutcome in this study will justify evaluation in larger numbers of patients and in other tumorindications.. However, pancreatic tumors withnucleoside transporter (hENT1) deficiency may show less benefit from gemcitabine comparedwith those with higher expression of the transporter. Nonclinical studies indicate that CO-1.01 isindependent of such transporters. Therefore, patients with low expression of hENT1 treated withCO-1.01 may have a superior tumor outcome compared with patients treated with gemcitabine.The PK profiles of CO-1.01 and gemcitabine are different and this may also favorably influencethe antiproliferative effects of CO-1.01.The primary objective of this study is to compare the OS of patients with metastatic pancreaticcarcinoma and low hENT1 expression treated with CO-1.01 and gemcitabine. The antitumorefficacy of CO-1.01 and gemcitabine in all patients with metastatic pancreatic carcinoma,irrespective of hENT1 status, will also be assessed and correlated with a biomarker (CA 19-9)changes over time. The toxicity of CO-1.01 will be compared with gemcitabine. Pain severity,health status, and pharmacogenetic biomarkers will be evaluated. Sparse sampling forpopulation PK analyses will also be conducted in all patients treated with CO-1.01. A positiveoutcome in this study will justify evaluation in larger numbers of patients and in other tumorindications.

Schlagworte

Chemotherapie, Pankreaskarzinom, palliativ
Kontakt

weitere Projekte

Die Daten werden geladen ...