Dose Escalation Study With Zactima and Chemotherapy in Metastastic Pancreas Carcinoma

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: May 20, 2008
Last updated: February 13, 2015
Last verified: February 2015
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

Condition Intervention Phase
Pancreatic Cancer
Drug: Vandetanib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose Escalation Study of the Combination of ZD6474, Gemicitabine and Capecitabine in Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Define Maximum Tolerated Dose (MTD) [ Time Frame: during whole study ] [ Designated as safety issue: Yes ]
  • Define Recommended Dose (RD) [ Time Frame: during whole study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate safety profile [ Time Frame: during whole study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: July 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dose level 1
Vandetanib 100mg/day plus Gemcitabine
Drug: Vandetanib
Other Name: Zactima
Active Comparator: Dose level 2
Vandetanib 300mg/day plus Gemcitabine
Drug: Vandetanib
Other Name: Zactima
Active Comparator: Dose level 3
Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose
Drug: Vandetanib
Other Name: Zactima
Active Comparator: Doselevel 4
Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose
Drug: Vandetanib
Other Name: Zactima


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00681798

Research Site
St Gallen, SG, Switzerland
Research Site
Bellinzona, Switzerland
Sponsors and Collaborators
Principal Investigator: Piercarlo Saletti, MD Bellinzona, Switzerland
Study Director: Madeleine Billeter, MD Zug, Switzerland
Study Chair: Verena Renggli, dipl. Pharm Zug, Switzerland
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00681798     History of Changes
Other Study ID Numbers: D4200L00003 
Study First Received: May 20, 2008
Last Updated: February 13, 2015
Health Authority: Switzerland: Swissmedic

Keywords provided by AstraZeneca:
pancreatic cancer
pancreatic adenocarcinomina
pancreas cancer
dose escalation study
locally advanced unresectable pancreatic adenocarcinoma

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases processed this record on August 25, 2016