Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients

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

A Phase I study to assess the safety and tolerability of AZD2281 in combination with Cisplatin in patients with advanced Solid Tumours. This is an open label-dose finding; to establish the maximum tolerated dose of AZD2281 combined with Cisplatin in patients with advanced solid tumours. Approximately 50 (max 60) patients from 2 countries will be enrolled

Inclusion Criteria:

• Life expectancy of at least 12 weeks
• Histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent
• Patients with measurable or non measurable disease according to RECIST

Exclusion Criteria:

• Less than 28 days from active therapy (ie any treatment used to treat the disease) or high dose radiotherapy
• Brain Metastases or spinal cord compression unless irradiated at least 4 weeks before entry and stable without steroid treatment for >1 week
• Persistent CTCAE Grade 2 or greater toxicities (excluding alopecia) caused by prior therapy