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
- Histologically or cytologically confirmed malignant solid tumour and refractory to
standard therapy or for which no suitable effective standard therapy exists.
- 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:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of this study is to determine the safety and tolerability of AZD2281.
Outcome Time Frame:
assessed after each visit
Japan: Pharmaceuticals and Medical Devices Agency
- Advanced Solid Malignancies
- Advanced solid malignancies