Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma

August 26, 2016 updated by: Sanofi

Dose Escalation Study of the Combination of ZD6474, Gemcitabine and Capecitabine in Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • Switzerland
      • Bellinzona, Switzerland
        • Research Site
    • SG
      • St Gallen, SG, Switzerland
        • Research Site

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dose level 1
Vandetanib 100mg/day plus Gemcitabine
Drug: Vandetanib
100mg/300mg
Other Names:
  • Zactima
Active Comparator: Dose level 2
Vandetanib 300mg/day plus Gemcitabine
Drug: Vandetanib
100mg/300mg
Other Names:
  • Zactima
Active Comparator: Dose level 3
Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose
Drug: Vandetanib
100mg/300mg
Other Names:
  • Zactima
Active Comparator: Dose level 4
Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose
Drug: Vandetanib
100mg/300mg
Other Names:
  • Zactima

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate safety profile
Time Frame: during whole study
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
every 2 months

Collaborators and Investigators

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

Sponsor

Sanofi

Publications and helpful links

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

General Publications

Helpful Links

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 Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

May 20, 2008

First Submitted That Met QC Criteria

May 20, 2008

First Posted (Estimate)

May 21, 2008

Study Record Updates

Last Update Posted (Estimate)

August 29, 2016

Last Update Submitted That Met QC Criteria

August 26, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4200L00003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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