AZD2281 in Combination With Liposomal Doxorubicin in Advanced Solid Tumours

Phase 1

Terminated

• Conditions: Solid Tumors
• Interventions: Drug: AZD2281; Drug: liposomal doxorubicin

• Registration Number: NCT00819221
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-05
• Study First Submitted: 2009-01-07
• Study First Submitted QC: 2009-01-07
• Study First Posted: 2009-01-08
• Primary Completion: 2011-11-30
• Study Completion: 2021-12-22
• Status Verified: 2022-02
• Last Update Submitted: 2022-08-25
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	liposomal doxorubicin	-
1	AZD2281	-

Primary Outcome Measures

Name	Time	Method
recommended dose	2 months

Secondary Outcome Measures

Name	Time	Method
DNA repair mechanism	once
pharmacokinetics	6 visits within 1 month
safety/tolerability/toxicity	2 months

Trial Locations

Locations (1)

Research Site; 🇨🇭 Chur, Switzerland