This trial is active, not recruiting.

Condition solid tumors
Treatments azd2281, liposomal doxorubicin
Phase phase 1
Target PARP
Sponsor AstraZeneca
Start date January 2009
End date November 2011
Trial size 44 participants
Trial identifier NCT00819221, D0810L00001, Eudract No. 2008-007680-17


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics/dynamics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
azd2281 Olaparib
capsules, oral, bd, 2 months
liposomal doxorubicin
once every 4 weeks at 40mg/m2

Primary Outcomes

recommended dose
time frame: 2 months

Secondary Outcomes

time frame: 6 visits within 1 month
time frame: 2 months
DNA repair mechanism
time frame: once

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.