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AZD2281 in Combination With Liposomal Doxorubicin in Advanced Solid Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00819221
Recruitment Status : Active, not recruiting
First Posted : January 8, 2009
Last Update Posted : January 9, 2020
Information provided by (Responsible Party):

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

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Study Type : Interventional  (Clinical Trial)
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 : January 5, 2009
Actual Primary Completion Date : November 30, 2011
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: AZD2281
capsules, oral, bd, 2 months
Other Name: Olaparib

Drug: liposomal doxorubicin
once every 4 weeks at 40mg/m2

Primary Outcome Measures :
  1. recommended dose [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. pharmacokinetics [ Time Frame: 6 visits within 1 month ]
  2. safety/tolerability/toxicity [ Time Frame: 2 months ]
  3. DNA repair mechanism [ Time Frame: once ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00819221

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Research Site
Milano, Italy, 20133
Research Site
Bellinzona, Switzerland, CH-6500
Research Site
Chur, Switzerland, CH-7000
Sponsors and Collaborators
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Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AstraZeneca Identifier: NCT00819221    
Other Study ID Numbers: D0810L00001
Eudract No. 2008-007680-17
First Posted: January 8, 2009    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Keywords provided by AstraZeneca:
advanced tumors
solid tumors
dose escalation
liposomal doxorubicin
phase I
Additional relevant MeSH terms:
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Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Poly(ADP-ribose) Polymerase Inhibitors