search
Back to results

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
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 20, 2008
Last Updated
August 26, 2016
Sponsor
Sanofi
search

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

We'll reach out to this number within 24 hrs