AZD2281 in Combination With Liposomal Doxorubicin in Advanced Solid Tumours

A Phase I, Open Label, Multicenter Study to Assess the Safety, Tolerability and Pharmacology of AZD2281 in Combination With Liposomal Doxorubicin (Caelyx®) in Patients With Advanced Solid Tumors

The study will be an open label, multicenter, dose finding study. Depending on the tolerated dose up to 7 dose levels will be explored in this study, approximately 33 patients (21-54 depending on number of cohorts) may be enrolled into this study. Three patients will be initially dosed in each cohort. The primary objective of this study is to determine the recommended dose (RD) of twice daily oral doses of AZD2281 either as intermittent therapy for 7 days out of a 28-day schedule or given continuously, administered in combination with liposomal doxorubicin to patients with advanced solid tumors.

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent
• Measurable or evaluable disease
• ECOG Performance status 0 - 2
• Estimated life expectancy of at least 12 weeks

Exclusion Criteria:

• More than 3 prior lines of chemotherapy for advanced disease
• Less than 28 days from active treatment (ie, any treatment used to treat the disease) or high dose radiotherapy (patients may continue concomitant use of stable dose of bisphosphonates if used at least 28 days prior to commencing study treatment and pat
• Prior treatment with >300mg/m2 cumulative dose of doxorubicin equivalent
• Resistance to anthracyclines defined as progressive disease during anthracycline treatment or within 6 months after the last anthracycline administration.