A Phase I, Open-label, Dose Escalation Study to Assess the Safety and Tolerability of AZD2281 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies
Phase 1
20 Years
74 Years
20 Years
74 Years
Not Enrolling
Both
Advanced Solid Malignancies
Both
Advanced Solid Malignancies
Trial Information
A Phase I, Open-label, Dose Escalation Study to Assess the Safety and Tolerability of AZD2281 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies
Inclusion Criteria:
- Histologically or cytologically confirmed malignant solid tumour and refractory to
standard therapy or for which no suitable effective standard therapy exists.
Exclusion Criteria:
- Patients undergone, within 4 weeks prior to trial entry, an anti-cancer therapy which
includes chemotherapy (or a longer period depending on the defined characteristics of
the drugs used eg,. 6 weeks for mitomycin C or nitrosourea.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary objective of this study is to determine the safety and tolerability of AZD2281.
Outcome Time Frame:
assessed after each visit
Safety Issue:
No
Principal Investigator
James Carmichael
Investigator Role:
Study Director
Investigator Affiliation:
KuDOS/AstraZeneca
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
D0810C00001
NCT ID:
NCT00572364
Start Date:
November 2007
Completion Date:
June 2009
Related Keywords:
- Advanced Solid Malignancies
- Cancer
- Advanced solid malignancies
- Neoplasms
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