Phase I Single Ascending Dose/Multiple Ascending Dose in Patients treated with AZD7762 and Irinotecan
Study identifier:D1040C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Phase I open-label, multi-center, dose-escalation and safety expansion study to assess safety, tolerability, and pharmacokinectics of AZD7762 administered as a single intravenous agent and in combination with weekly standard dose of irinotecan in patients with advanced solid malignancies.
Medical condition
Advanced Solid Tumors
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD7762, Irinotecan
Sex
All
Actual Enrollment
60
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 May 2007
Primary Completion Date: 01 Jan 2011
Study Completion Date: 01 Jan 2011
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel 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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| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD7762 monotherapy followed by AZD7762 + irinotecan | Drug: AZD7762 intravenous infusion Drug: Irinotecan intravenous injection Other Name: Campto® Other Name: Camptosar® Other Name: irinotecan hydrochloride |
Contacts
Investigators
Principal Investigator
Peter Langmuir
AstraZeneca
