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Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00681798
First Posted: May 21, 2008
Last Update Posted: August 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
May 20, 2008
May 21, 2008
August 29, 2016
July 2006
June 2009   (Final data collection date for primary outcome measure)
  • Define Maximum Tolerated Dose (MTD) [ Time Frame: during whole study ]
  • Define Recommended Dose (RD) [ Time Frame: during whole study ]
Same as current
Complete list of historical versions of study NCT00681798 on ClinicalTrials.gov Archive Site
  • Evaluate safety profile [ Time Frame: 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 ]
Same as current
Not Provided
Not Provided
 
Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma
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
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Cancer
Drug: Vandetanib
100mg/300mg
Other Name: Zactima
  • Active Comparator: Dose level 1
    Vandetanib 100mg/day plus Gemcitabine
    Intervention: Drug: Vandetanib
  • Active Comparator: Dose level 2
    Vandetanib 300mg/day plus Gemcitabine
    Intervention: Drug: Vandetanib
  • Active Comparator: Dose level 3
    Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose
    Intervention: Drug: Vandetanib
  • Active Comparator: Dose level 4
    Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose
    Intervention: Drug: Vandetanib
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
June 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT00681798
D4200L00003
No
Not Provided
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP