Phase I AZD2281/Cisplatin in Advanced Solid Tumour patients
Study identifier:D0810C00021
ClinicalTrials.gov identifier:NCT00782574
EudraCT identifier:2008-000062-24
CTIS identifier:N/A
Recruitment Complete
Official Title
A Phase I Open label, Multi centre study of AZD2281 Administered Orally in combination With Cisplatin, to assess the Safety and Tolerability in Patients with Advanced Solid Tumours
Medical condition
Advanced Solid Tumors
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD2281, Cisplatin
Sex
All
Actual Enrollment
57
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 12 Nov 2008
Primary Completion Date: 01 Feb 2012
Estimated Study Completion Date: 29 Dec 2023
Study design
Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions. | Drug: AZD2281 Tablets Oral BID Other Name: Olaparib; Lynparza Drug: Cisplatin IV every 3 weeks |
Contacts
Investigators
Principal Investigator
Jane Robertson
AstraZeneca
