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


Phase 1
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Define Maximum Tolerated Dose (MTD)

Outcome Time Frame:

during whole study

Safety Issue:

Yes

Principal Investigator

Piercarlo Saletti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bellinzona, Switzerland

Authority:

Switzerland: Swissmedic

Study ID:

D4200L00003

NCT ID:

NCT00681798

Start Date:

July 2006

Completion Date:

June 2009

Related Keywords:

  • Pancreatic Cancer
  • pancreatic cancer
  • pancreatic adenocarcinomina
  • pancreas cancer
  • dose escalation study
  • locally advanced unresectable pancreatic adenocarcinoma
  • Zactima
  • Vandetanib
  • ZD6474
  • Adenocarcinoma
  • Pancreatic Neoplasms

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