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Study of GemOx and Vandetanib in Advanced Solid Malignancy

NCT00660725 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2014-01-23

No results posted yet for this study

Summary

This is a research study that will try to find the highest and safest dose of an experimental drug, vandetanib, that can be given in combination with two standard chemotherapy agents, gemcitabine and oxaliplatin, to subjects with advanced solid malignancies.

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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Leonard Appleman

    lead OTHER

Principal Investigators

  • Leonard J. Appleman, M.D., Ph.D. · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-11-30
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00660725 on ClinicalTrials.gov