Study of GemOx and Vandetanib in Advanced Solid Malignancy

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

November 30, 2010

Study Completion Date

December 31, 2010

Conditions
Advanced Incurable Solid Malignancy
Interventions
DRUG

Vandetanib

Vandetanib is a pill that will be self-administered orally on Days 1-14 of each 14-day cycle. The dose of vandetanib each subject will receive will be determined by a dose escalation schedule (either 200 mg or 300 mg per day), which will be followed to determine the MTD of the study drug combination (vandetanib + GemOx). In the absence of disease progression, unacceptable toxicities, or other complications, the vandetanib and GemOx combination may continue per protocol for a maximum of 6 cycles, or 12 weeks. In subjects who show response or stable disease, vandetanib may be continued as a single agent beyond the 6 cycle maximum, at the investigator's discretion.

DRUG

Gemcitabine

30-minute IV infusion of 1000 mg/m\^2 gemcitabine on Day 1 of each 14-day cycle.

DRUG

Oxaliplatin

Immediately following gemcitabine IV: 2-hour IV infusion of 85 mg/m\^2 oxaliplatin on Day 1 of each 14-day cycle.

Trial Locations (1)

15232

University of Pittsburgh Cancer Institute / Hillman Cancer Center, Pittsburgh

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Leonard Appleman

OTHER