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CompletedNCT00681798Updated Aug 29, 2016

Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma

A Phase 1 interventional study of Vandetanib in Pancreatic Cancer, sponsored by Sanofi. Completed at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-29.

Sponsored by Sanofi · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • pancreatic cancer
  • pancreatic adenocarcinoma
  • pancreas cancer
  • dose escalation study
  • locally advanced unresectable pancreatic adenocarcinoma
  • Zactima
  • Vandetanib
  • ZD6474
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 8 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Confirmed diagnosis of locally advanced unresectable or metastatic pancreatic adenocarcinoma
  • ECOG performance status \<1
  • Measurable disease

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Active comparator
    Dose level 1

    Vandetanib 100mg/day plus Gemcitabine

    Drug: Vandetanib

  • Active comparator
    Dose level 2

    Vandetanib 300mg/day plus Gemcitabine

    Drug: Vandetanib

  • Active comparator
    Dose level 3

    Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose

    Drug: Vandetanib

  • Active comparator
    Dose level 4

    Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose

    Drug: Vandetanib

Interventions

  • DrugVandetanib

    100mg/300mg

    Also known as: Zactima

06

What researchers measure

Primary outcomes

  1. Define Maximum Tolerated Dose (MTD)

    Time frame: during whole study

  2. Define Recommended Dose (RD)

    Time frame: during whole study

Secondary outcomes

  1. Evaluate safety profile

    Time frame: during whole study

  2. 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

07

Study locations

2 sites
  • Research Site
    St Gallen, SG, Switzerland
  • Research Site
    Bellinzona, Switzerland
08

References and documents

Publications

  • 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. PubMed 21921646 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00681798
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
May 21, 2008
Start date
Jul 2006
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Aug 29, 2016

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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