AZD2281 in Combination With Liposomal Doxorubicin in Advanced Solid Tumours

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00819221
First received: January 7, 2009
Last updated: February 21, 2013
Last verified: February 2013
  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: 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: August 2013
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819221

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00819221     History of Changes
Other Study ID Numbers: D0810L00001, Eudract No. 2008-007680-17
Study First Received: January 7, 2009
Last Updated: February 21, 2013
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Neoplasms
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014