Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: Vandetanib

• Registration Number: NCT00681798
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2008-05-20
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-21
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-26
• Last Update Posted: 2016-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose level 1	Vandetanib	Vandetanib 100mg/day plus Gemcitabine
Dose level 2	Vandetanib	Vandetanib 300mg/day plus Gemcitabine
Dose level 3	Vandetanib	Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose
Dose level 4	Vandetanib	Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose

Primary Outcome Measures

Name	Time	Method
Define Maximum Tolerated Dose (MTD)	during whole study
Define Recommended Dose (RD)	during whole study

Secondary Outcome Measures

Name	Time	Method
Evaluate safety profile	during whole study
Determine antitumour activity as determined by overall response rate (RR), progression free survival (PFS), disease control rate and duration of response	every 2 months

Trial Locations

Locations (1)

Research Site; 🇨🇭 Bellinzona, Switzerland