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
1 other identifier
interventional
8
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 pancreatic-cancer
Started Jul 2006
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 20, 2008
CompletedFirst Posted
Study publicly available on registry
May 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedAugust 29, 2016
August 1, 2016
2.9 years
May 20, 2008
August 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Define Maximum Tolerated Dose (MTD)
during whole study
Define Recommended Dose (RD)
during whole study
Secondary Outcomes (2)
Evaluate safety profile
during whole study
Determine antitumour activity as determined by overall response rate (RR), progression free survival (PFS), disease control rate and duration of response
every 2 months
Study Arms (4)
Dose level 1
ACTIVE COMPARATORVandetanib 100mg/day plus Gemcitabine
Dose level 2
ACTIVE COMPARATORVandetanib 300mg/day plus Gemcitabine
Dose level 3
ACTIVE COMPARATORVandetanib 100mg/day plus Gemcitabine plus CapecitabineDose
Dose level 4
ACTIVE COMPARATORVandetanib 300mg/day plus Gemcitabine plus CapectiabineDose
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of locally advanced unresectable or metastatic pancreatic adenocarcinoma
- ECOG performance status \<1
- Measurable disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (2)
Research Site
Sankt Gallen, Canton of St. Gallen, Switzerland
Research Site
Bellinzona, Switzerland
Related 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.
PMID: 21921646BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2008
First Posted
May 21, 2008
Study Start
July 1, 2006
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
August 29, 2016
Record last verified: 2016-08