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Dose Escalation Study With Zactima and Chemotherapy in Metastastic Pancreas Carcinoma

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00681798
First received: May 20, 2008
Last updated: October 1, 2009
Last verified: October 2009
History of Changes
  Purpose

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:

Drug Information available for: Vandetanib
U.S. FDA Resources

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 ]

Estimated Enrollment: 15
Study Start Date: July 2006
Study Completion Date: June 2009
Arms Assigned Interventions
Active Comparator: Dose level 1
Vandetanib 100mg/day plus Gemcitabine
 Drug: Vandetanib
100mg/300mg
Other Name: Zactima
Active Comparator: Dose level 2
Vandetanib 300mg/day plus Gemcitabine
 Drug: Vandetanib
100mg/300mg
Other Name: Zactima
Active Comparator: Dose level 3
Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose
 Drug: Vandetanib
100mg/300mg
Other Name: Zactima
Active Comparator: Doselevel 4
Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose
 Drug: Vandetanib
100mg/300mg
Other Name: Zactima

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681798

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

No publications provided

Responsible Party: Dr. med. Madeleine Billeter, Medical Director, AstraZeneca AG Switzerland
ClinicalTrials.gov Identifier: NCT00681798     History of Changes
Other Study ID Numbers: D4200L00003
Study First Received: May 20, 2008
Last Updated: October 1, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by AstraZeneca:
pancreatic cancer
pancreatic adenocarcinomina
pancreas cancer
dose escalation study
 locally advanced unresectable pancreatic adenocarcinoma
Zactima
Vandetanib
ZD6474

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013