AZD2281 in Combination With Liposomal Doxorubicin in Advanced Solid Tumours

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: January 7, 2009
Last updated: May 12, 2016
Last verified: May 2016
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 Intervention Phase
Solid Tumors
Drug: AZD2281
Drug: liposomal doxorubicin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • recommended dose [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pharmacokinetics [ Time Frame: 6 visits within 1 month ] [ Designated as safety issue: Yes ]
  • safety/tolerability/toxicity [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • DNA repair mechanism [ Time Frame: once ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: January 2009
Estimated Study Completion Date: September 2016
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD2281
capsules, oral, bd, 2 months
Other Name: Olaparib
Drug: liposomal doxorubicin
once every 4 weeks at 40mg/m2


Ages Eligible for Study:   18 Years to 150 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00819221

Research Site
Milano, Italy
Research Site
Bellinzona, Switzerland
Research Site
Chur, Switzerland
Sponsors and Collaborators
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00819221     History of Changes
Other Study ID Numbers: D0810L00001  Eudract No. 2008-007680-17 
Study First Received: January 7, 2009
Last Updated: May 12, 2016
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Switzerland: Swissmedic

Keywords provided by AstraZeneca:
advanced tumors
solid tumors
dose escalation
liposomal doxorubicin
phase I

Additional relevant MeSH terms:
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on May 30, 2016