AZD2281 in Combination With Liposomal Doxorubicin in Advanced Solid Tumours

Sponsor

AstraZeneca (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT00819221

Collaborator

(none)

Enrollment

Locations

Arm

158.8

Anticipated Duration (Months)

14.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors	Drug: AZD2281 Drug: liposomal doxorubicin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 5, 2009

Actual Primary Completion Date :

Nov 30, 2011

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: AZD2281 capsules, oral, bd, 2 months Other Names: Olaparib Drug: liposomal doxorubicin once every 4 weeks at 40mg/m2

Arm

Intervention/Treatment

Experimental: 1

Drug: AZD2281

capsules, oral, bd, 2 months

Other Names:

Olaparib

Drug: liposomal doxorubicin

once every 4 weeks at 40mg/m2

Outcome Measures

Primary Outcome Measures

recommended dose [2 months]

Secondary Outcome Measures

pharmacokinetics [6 visits within 1 month]
safety/tolerability/toxicity [2 months]
DNA repair mechanism [once]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 130 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.