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AZD2281 in Combination With Liposomal Doxorubicin in Advanced Solid Tumours

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00819221
First Posted: January 8, 2009
Last Update Posted: September 19, 2017
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.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

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

Enrollment: 44
Actual Study Start Date: January 5, 2009
Estimated Study Completion Date: December 31, 2017
Primary Completion Date: November 30, 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00819221


Locations
Italy
Research Site
Milano, Italy, 20133
Switzerland
Research Site
Bellinzona, Switzerland, CH-6500
Research Site
Chur, Switzerland, CH-7000
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00819221     History of Changes
Other Study ID Numbers: D0810L00001
Eudract No. 2008-007680-17
First Submitted: January 7, 2009
First Posted: January 8, 2009
Last Update Posted: September 19, 2017
Last Verified: September 2017

Keywords provided by AstraZeneca:
advanced tumors
solid tumors
dose escalation
combination
AZD2281
liposomal doxorubicin
pharmacology
phase I
multicenter

Additional relevant MeSH terms:
Doxorubicin
Liposomal doxorubicin
Olaparib
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Poly(ADP-ribose) Polymerase Inhibitors