Assess the efficacy of AZD8931 in Combination with Paclitaxel versus Paclitaxel alone in Patients with Gastric Cancer
Study identifier:D0102C00006
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Phase IIa Multi-centre Randomised Double-Blind Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of AZD8931 in Combination with Paclitaxel versus Paclitaxel alone in Patients with Metastatic, Gastric or Gastro-oesophageal Junction, Cancer who progress following First Line Therapy and are Ineligible for Treatment with trastuzumab by HER2 Status (SAGE)
Medical condition
Metastatic, Gastric or Gastro-oesophageal Junction, Cancer
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD8931, Placebo, Paclitaxel
Sex
All
Actual Enrollment
39
Study type
Interventional
Age
18 Years - 150 Years
Date
Study Start Date: 01 Apr 2012
Primary Completion Date: 01 Mar 2013
Study Completion Date: 01 Mar 2013
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: AZD8931 40 mg, oral dose twice daily Drug: Paclitaxel IV once weekly for 3 weeks followed by a week off. |
| Placebo Comparator: 2 | Drug: Placebo Placebo, oral dose twice daily Drug: Paclitaxel IV once weekly for 3 weeks followed by a week off. |
Contacts
Investigators
Principal Investigator
Serban Ghiorghiu
Scarborough General Hospital
