AZD2281 in Combination With Liposomal Doxorubicin in Advanced Solid Tumours

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00819221

Enrollment

Registered

2009-01-08

Start date

2009-01-05

Completion date

2021-12-22

Last updated

2022-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Keywords

advanced tumors, solid tumors, dose escalation, combination, AZD2281, liposomal doxorubicin, pharmacology, phase I, multicenter

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.

Interventions

DRUGAZD2281

capsules, oral, bd, 2 months

DRUGliposomal doxorubicin

once every 4 weeks at 40mg/m2

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 130 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
recommended dose	2 months

Secondary

Measure	Time frame
DNA repair mechanism	once
pharmacokinetics	6 visits within 1 month
safety/tolerability/toxicity	2 months

Countries

Italy, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026