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Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients

NCT ID: NCT00782574

Last Updated: 2023-12-21

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-12

Study Completion Date

2023-12-07

Brief Summary

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A Phase I study to assess the safety and tolerability of AZD2281 in combination with Cisplatin in patients with advanced Solid Tumours. This is an open label-dose finding; to establish the maximum tolerated dose of AZD2281 combined with Cisplatin in patients with advanced solid tumours. Approximately 50 (max 60) patients from 2 countries will be enrolled

Detailed Description

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Conditions

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Advanced Solid Tumors

Keywords

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Advanced solid tumours Poly(ADP ribose) polymerases homologous deficiency BRCA1

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

Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator.

Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid).

The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions.

Group Type EXPERIMENTAL

AZD2281

Intervention Type DRUG

Tablets Oral BID

Cisplatin

Intervention Type DRUG

IV every 3 weeks

Interventions

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AZD2281

Tablets Oral BID

Intervention Type DRUG

Cisplatin

IV every 3 weeks

Intervention Type DRUG

Other Intervention Names

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Olaparib; Lynparza

Eligibility Criteria

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Inclusion Criteria

* Life expectancy of at least 12 weeks
* Histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent
* Patients with measurable or non measurable disease according to RECIST

Exclusion Criteria

* Less than 28 days from active therapy (ie any treatment used to treat the disease) or high dose radiotherapy
* Brain Metastases or spinal cord compression unless irradiated at least 4 weeks before entry and stable without steroid treatment for \>1 week
* Persistent CTCAE Grade 2 or greater toxicities (excluding alopecia) caused by prior therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jane Robertson, BSc, MBCHB, MD

Role: STUDY_DIRECTOR

AstraZeneca

Judy E Garber

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

J Ballmana Gelpi

Role: PRINCIPAL_INVESTIGATOR

Vall d'Hebron

Locations

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Research Site

Boston, Massachusetts, United States

Site Status

Research Site

Boston, Massachusetts, United States

Site Status

Research Site

Barcelona, , Spain

Site Status

Countries

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United States Spain

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1674&filename=D0810C00021_revised_CSP_6_redacted_SECURED.pdf

D0810C00021 redacted protocol

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1674&filename=D0810C00021.pdf

CSR\_Synopsis\_D0810C00021.pdf

Other Identifiers

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2008-000062-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D0810C00021

Identifier Type: -

Identifier Source: org_study_id