AZD2281 in Combination With Liposomal Doxorubicin in Advanced Solid Tumours

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-05

Study Completion Date

2021-12-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

AZD2281

Intervention Type DRUG

capsules, oral, bd, 2 months

liposomal doxorubicin

Intervention Type DRUG

once every 4 weeks at 40mg/m2

Interventions

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AZD2281

capsules, oral, bd, 2 months

Intervention Type DRUG

liposomal doxorubicin

once every 4 weeks at 40mg/m2

Intervention Type DRUG

Other Intervention Names

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Olaparib

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No