Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma

Sanofi8 enrolled

Overview

The purpose of this study is to define th Maximum Tolerated Dose (MTD) and the recommended dose (RD) of ZD6474 in combination with a fixed standard dose of gemcitabine and capecitabine

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

VandetanibDRUG

100mg/300mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed diagnosis of locally advanced unresectable or metastatic pancreatic adenocarcinoma * ECOG performance status \<1 * Measurable disease Exclusion Criteria: * Severe or uncontrolled systemic disease * Clinically significant cardiac event such as myocardial infarction * Any concomitant medication that may cause OTc prolongation, include Torsades de Pointes

Locations (2)

Research Site

Sankt Gallen, Canton of St. Gallen, Switzerland

Research Site

Bellinzona, Switzerland

Outcomes

Primary Outcomes

Define Maximum Tolerated Dose (MTD)

Time frame: during whole study

Define Recommended Dose (RD)

Time frame: during whole study

Secondary Outcomes

Evaluate safety profile

Time frame: during whole study

Determine antitumour activity as determined by overall response rate (RR), progression free survival (PFS), disease control rate and duration of response

Time frame: every 2 months

Data from ClinicalTrials.gov

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