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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00681798

Enrollment

Registered

2008-05-21

Start date

2006-07-31

Completion date

2009-06-30

Last updated

2016-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer, pancreatic adenocarcinoma, pancreas cancer, dose escalation study, locally advanced unresectable pancreatic adenocarcinoma, Zactima, Vandetanib, ZD6474

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

Interventions

DRUGVandetanib

100mg/300mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Define Maximum Tolerated Dose (MTD)	during whole study
Define Recommended Dose (RD)	during whole study

Secondary

Measure	Time frame
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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026