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OpenTrials
Completed

NCT Number: NCT00681798

Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma

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

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Sankt Gallen, Canton of St. Gallen, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vandetanib

Drug

100mg/300mg

Other names: Zactima

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Dose Escalation Study of the Combination of ZD6474, Gemcitabine and Capecitabine in Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 21, 2008
Registry last updated
Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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