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Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918

NCT00733031 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2010-12-10

No results posted yet for this study

Summary

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918 will be administered twice daily. Then maximum tolerated doses in combination with either gemcitabine or pemetrexed will also be investigated.

Conditions

Interventions

DRUG

AZD6918

liquid suspension, daily, oral dose

DRUG

gemcitabine

intravenous, doses are on an intermittent schedule

DRUG

pemetrexed

intravenous, dose administered every 21-days

Sponsors & Collaborators

Principal Investigators

  • Judith Ochs, MD · AstraZeneca

  • Jeffrey Infante, MD · SCRI Development Innovations, LLC

  • Lia Gore, MD · University of Colorado, Denver

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00733031 on ClinicalTrials.gov