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NCT00819221 Clinical Trial

AZD2281 in Combination With Liposomal Doxorubicin in Advanced Solid Tumours

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00819221
Other study ID # D0810L00001
Secondary ID Eudract No. 2008
Status Terminated
Phase Phase 1
First received
Last updated
Start date January 5, 2009
Est. completion date December 22, 2021

Study information
Verified date February 2022
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 44
Est. completion date December 22, 2021
Est. primary completion date November 30, 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• AZD2281
capsules, oral, bd, 2 months
• liposomal doxorubicin
once every 4 weeks at 40mg/m2

Locations
Country Name City State
Italy Research Site Milano
Switzerland Research Site Bellinzona
Switzerland Research Site Chur

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Italy,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary recommended dose 2 months
Secondary pharmacokinetics 6 visits within 1 month
Secondary safety/tolerability/toxicity 2 months
Secondary DNA repair mechanism once
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