Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Vandetanib
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, pancreatic adenocarcinoma, pancreas cancer, dose escalation study, locally advanced unresectable pancreatic adenocarcinoma, Zactima, Vandetanib, ZD6474
Eligibility Criteria
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
Sites / Locations
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Dose level 1
Dose level 2
Dose level 3
Dose level 4
Arm Description
Vandetanib 100mg/day plus Gemcitabine
Vandetanib 300mg/day plus Gemcitabine
Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose
Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose
Outcomes
Primary Outcome Measures
Define Maximum Tolerated Dose (MTD)
Define Recommended Dose (RD)
Secondary Outcome Measures
Evaluate safety profile
Determine antitumour activity as determined by overall response rate (RR), progression free survival (PFS), disease control rate and duration of response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00681798
Brief Title
Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma
Official Title
Dose Escalation Study of the Combination of ZD6474, Gemcitabine and Capecitabine in Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
pancreatic cancer, pancreatic adenocarcinoma, pancreas cancer, dose escalation study, locally advanced unresectable pancreatic adenocarcinoma, Zactima, Vandetanib, ZD6474
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose level 1
Arm Type
Active Comparator
Arm Description
Vandetanib 100mg/day plus Gemcitabine
Arm Title
Dose level 2
Arm Type
Active Comparator
Arm Description
Vandetanib 300mg/day plus Gemcitabine
Arm Title
Dose level 3
Arm Type
Active Comparator
Arm Description
Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose
Arm Title
Dose level 4
Arm Type
Active Comparator
Arm Description
Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose
Intervention Type
Drug
Intervention Name(s)
Vandetanib
Other Intervention Name(s)
Zactima
Intervention Description
100mg/300mg
Primary Outcome Measure Information:
Title
Define Maximum Tolerated Dose (MTD)
Time Frame
during whole study
Title
Define Recommended Dose (RD)
Time Frame
during whole study
Secondary Outcome Measure Information:
Title
Evaluate safety profile
Time Frame
during whole study
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
St Gallen
State/Province
SG
Country
Switzerland
Facility Name
Research Site
City
Bellinzona
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21921646
Citation
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.
Results Reference
background
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1439&filename=CSR-D4200L00003.pdf
Description
D4200L00003 CSR Synopsis
Learn more about this trial
Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma
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