NCT00819221

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_1

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2011

Completed
10.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2021

Completed
Last Updated

August 30, 2022

Status Verified

February 1, 2022

Enrollment Period

2.9 years

First QC Date

January 7, 2009

Last Update Submit

August 25, 2022

Conditions

Solid Tumors

Keywords

advanced tumorssolid tumorsdose escalationcombinationAZD2281liposomal doxorubicinpharmacologyphase Imulticenter

Outcome Measures

Primary Outcomes (1)

  • recommended dose

    2 months

Secondary Outcomes (3)

  • pharmacokinetics

    6 visits within 1 month

  • safety/tolerability/toxicity

    2 months

  • DNA repair mechanism

    once

Study Arms (1)

1

EXPERIMENTAL
Drug: AZD2281Drug: liposomal doxorubicin

Interventions

AZD2281DRUG

capsules, oral, bd, 2 months

Also known as: Olaparib
1
liposomal doxorubicinDRUG

once every 4 weeks at 40mg/m2

1

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Milan, 20133, Italy

Location

Research Site

Bellinzona, CH-6500, Switzerland

Location

Research Site

Chur, CH-7000, Switzerland

Location

Related Publications (1)

  • Del Conte G, Sessa C, von Moos R, Vigano L, Digena T, Locatelli A, Gallerani E, Fasolo A, Tessari A, Cathomas R, Gianni L. Phase I study of olaparib in combination with liposomal doxorubicin in patients with advanced solid tumours. Br J Cancer. 2014 Aug 12;111(4):651-9. doi: 10.1038/bjc.2014.345. Epub 2014 Jul 15.

    PMID: 25025963DERIVED

Related Links

MeSH Terms

Interventions

olaparibliposomal doxorubicin

Study Officials

  • Jane Robertson, BSc, MBCHB, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 8, 2009

Study Start

January 5, 2009

Primary Completion

November 30, 2011

Study Completion

December 22, 2021

Last Updated

August 30, 2022

Record last verified: 2022-02

Locations

CH(2)IT(1)