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Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00681798
First received: May 20, 2008
Last updated: August 26, 2016
Last verified: August 2016
  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, Gemcitabine and Capecitabine in Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Sanofi:

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
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: Dose level 4
Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose
Drug: Vandetanib
100mg/300mg
Other Name: Zactima

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Additional Information:
Publications:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00681798     History of Changes
Other Study ID Numbers: D4200L00003 
Study First Received: May 20, 2008
Last Updated: August 26, 2016
Health Authority: Switzerland: Swissmedic

Keywords provided by Sanofi:
pancreatic cancer
pancreatic adenocarcinoma
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
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016