Spots Global Cancer Trial Database for Phase I Dose Escalation Study of Intravenous VCN-01 With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: Phase I Dose Escalation Study of Intravenous VCN-01 With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors

Official Title: A Phase I, Multicenter, Open-label, Dose Escalation Study of Intravenous Administration of VCN-01 Oncolytic Adenovirus With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors

Study ID: NCT02045602

Conditions

Locally Advanced Solid Tumors

Metastatic Solid Tumors

Pancreatic Adenocarcinoma

Interventions

VCN-01

Gemcitabine

Abraxane®

Study Description

Brief Summary: The purpose of this study is to determine the safety and tolerability of VCN-01 either administered alone or in combination with Abraxane®/Gemcitabine, and to determine the recommended phase II dose of VCN-01 alone or in combination with Abraxane®/Gemcitabine.

Detailed Description: The study consists of three parts: * Part I is a dose escalation study to determine the safety and tolerability of a single intravenous injection of VCN-01 alone * In Part II the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine. * In Part III the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine in a "delayed" schedule compared with Part II.