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NCT00681798 Clinical Trial

Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00681798
Other study ID # D4200L00003
Secondary ID
Status Completed
Phase Phase 1
First received May 20, 2008
Last updated August 26, 2016
Start date July 2006
Est. completion date June 2009

Study information
Verified date August 2016
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Vandetanib
100mg/300mg

Locations
Country Name City State
Switzerland Research Site Bellinzona
Switzerland Research Site St Gallen SG

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Define Maximum Tolerated Dose (MTD) during whole study Yes
Primary Define Recommended Dose (RD) during whole study Yes
Secondary Evaluate safety profile during whole study Yes
Secondary Determine antitumour activity as determined by overall response rate (RR), progression free survival (PFS), disease control rate and duration of response every 2 months No
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