Phase I, open-label, dose-escalation, safety and PK study of AZD6918
Study identifier:D2785C00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6918 Administered Daily as a Single Agent and in Combination Treatment in Adult Patients with Refractory Solid Malignancies
Medical condition
cancer,
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD6918, gemcitabine, pemetrexed
Sex
All
Actual Enrollment
75
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Aug 2008
Primary Completion Date: 01 Mar 2009
Study Completion Date: 01 Mar 2009
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: gemcitabine gemcitabine administered in combination with AZD6918 | Drug: gemcitabine intravenous, doses are on an intermittent schedule Other Name: Gemzar |
| Experimental: pemetrexed pemetrexed administered in combination with AZD6918 | Drug: pemetrexed intravenous, dose administered every 21-days Other Name: Alimta |
| Experimental: AZD6918 AZD6918 administered alone | Drug: AZD6918 liquid suspension, daily, oral dose |
Contacts
Investigators
Principal Investigator
Judith Ochs
AstraZeneca
