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A Phase 2 Randomized, Open-Label, Multicenter Study Comparing CO-101 with Gemcitabine as First-Line Therapy in Patients with Metastatic Pancreatic AdenocarcinomaUnique Dataset IDPancrea_ClovisO_2010_186
Clinical Trial Title
A Phase 2 Randomized, Open-Label, Multicenter Study Comparing CO-101 with Gemcitabine as First-Line Therapy in Patients with Metastatic Pancreatic Adenocarcinoma
Trial Summary and Conditions
This open-label, randomized, controlled, multicenter Phase 2 study compared gemcitabine elaidate with gemcitabine as first-line therapy in patients with mPDAC. Eligible patients were randomized (1:1) to receive either gemcitabine elaidate or gemcitabine, which was infused intravenously over 30 ? 3 minutes, under medical supervision. Each cycle of gemcitabine elaidate was administered weekly for 3 of every 4 weeks (4th week rest) at a dose of 1250 mg/m2/day. The first cycle of gemcitabine comprised weekly administration of 1000 mg/m2/day for 7 weeks (8th week rest); subsequent cycles comprised weekly administration for 3 weeks every 4 weeks, in accordance with the manufacturer?s labeling. Dosing was to be delayed or decreased according to the protocol-specified toxicity criteria. Dose escalation beyond the starting dose was allowed if patients tolerated the first cycle (8 weeks) of gemcitabine or first 2 cycles (8 weeks) of gemcitabine elaidate, according to the criteria defined in the protocol. Protocol-specified treatment (PST) was continued until there was clinical tumor progression or unacceptable toxicity. The study was closed when the required number of events of death (80% events) had been observed in patients with low hENT1 tumor expression. Serial assessments for antitumor efficacy, adverse events, pain severity, and health status were performed in all patients. Tumor hENT1 status was determined after randomization but before the final efficacy analysis using predefined criteria to classify patients as hENT1 -high or -low so that the primary endpoint population (patients with low tumor hENT1 expression) could be identified prospectively.
Data includes raw safety, efficacy and demographics
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Primary: To compare the efficacy of gemcitabine elaidate and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) and low human equilibrative nucleoside transporter 1 (hENT1) expression. Secondary measures: To compare the efficacy of gemcitabine elaidate and gemcitabine in patients with mPDAC and known hENT1 status (all patients and high hENT1 expression). To compare the tolerability and toxicity of gemcitabine elaidate with gemcitabine. To compare changes in pain severity in patients receiving gemcitabine elaidate and gemcitabine. To compare changes in health status in patients receiving gemcitabine elaidate and gemcitabine. To perform sparse pharmacokinetic (PK) sampling in patients taking gemcitabine elaidate to contribute towards development of a population PK model of gemcitabine elaidate. To evaluate the clinical utility of the hENT1 diagnostic test.
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PROTOCOL: Protocol_CO-101-001_Amend2 20110314 final.pdf
CRF: CVSDVPAN-ADVPAN aCRF 13-Sep-2010_2.pdf
DATA DICTIONARY: define.pdf
DATA (ACTIVE ARM): SAP CO-101-001 Amendment 1 03May2012.docx
DATA (ACTIVE ARM): DataSphere.zip