Dose Escalation Study With Zactima And Chemotherapy In Metastatic Pancreas Carcinoma

Study Overview

Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma

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

N/A

Pancreatic Cancer

DRUG: Vandetanib

D4200L00003

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2008-05-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-08-26
First Submitted that Met QC Criteria 2008-05-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-08-29
First Posted (ESTIMATED) 2008-05-21	Results First Posted N/A	Last Verified 2016-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Dose level 1 Vandetanib 100mg/day plus Gemcitabine	DRUG: Vandetanib 100mg/300mg
ACTIVE_COMPARATOR: Dose level 2 Vandetanib 300mg/day plus Gemcitabine	DRUG: Vandetanib 100mg/300mg
ACTIVE_COMPARATOR: Dose level 3 Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose	DRUG: Vandetanib 100mg/300mg
ACTIVE_COMPARATOR: Dose level 4 Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose	DRUG: Vandetanib 100mg/300mg

Primary Outcome Measures	Measure Description	Time Frame
Define Maximum Tolerated Dose (MTD)		during whole study
Define Recommended Dose (RD)		during whole study

Secondary Outcome Measures	Measure Description	Time Frame
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Confirmed diagnosis of locally advanced unresectable or metastatic pancreatic adenocarcinoma
ECOG performance status <1
Measurable disease

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Clinical Sciences & Operations, Sanofi

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Saletti P, Sessa C, De Dosso S, Cerny T, Renggli V, Koeberle D. Phase I dose-finding study of vandetanib in combination with gemcitabine in locally advanced unresectable or metastatic pancreatic adenocarcinoma. Oncology. 2011;81(1):50-4. doi: 10.1159/000330769. Epub 2011 Sep 15.

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Resources

PatientS

Caregivers

Clinical Trial Record