Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00681798

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: Vandetanib	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dose level 1 Vandetanib 100mg/day plus Gemcitabine	Drug: Vandetanib 100mg/300mg Other Names: Zactima
Active Comparator: Dose level 2 Vandetanib 300mg/day plus Gemcitabine	Drug: Vandetanib 100mg/300mg Other Names: Zactima
Active Comparator: Dose level 3 Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose	Drug: Vandetanib 100mg/300mg Other Names: Zactima
Active Comparator: Dose level 4 Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose	Drug: Vandetanib 100mg/300mg Other Names: Zactima

Outcome Measures

Primary Outcome Measures

Define Maximum Tolerated Dose (MTD) [during whole study]
Define Recommended Dose (RD) [during whole study]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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