Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma

Sanofi

Status and phase: Completed; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: Vandetanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00681798

D4200L00003

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 4 patient groups

Dose level 1

Active Comparator group

Description:

Vandetanib 100mg/day plus Gemcitabine

Treatment:

Drug: Vandetanib

Dose level 2

Active Comparator group

Description:

Vandetanib 300mg/day plus Gemcitabine

Treatment:

Drug: Vandetanib

Dose level 3

Active Comparator group

Description:

Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose

Treatment:

Drug: Vandetanib

Dose level 4

Active Comparator group

Description:

Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose

Treatment:

Drug: Vandetanib