Study to Assess Safety and Tolerability of AZD0530 in Combination With Carboplatin and Paclitaxel

NCT ID: NCT01000896

Last Updated: 2010-02-04

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

WITHDRAWN

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-03-31

Brief Summary

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The primary purpose of this study is to explore the safety and tolerability of AZD0530 in combination with carboplatin and paclitaxel in Japanese patients with non small cell lung cancer and epithelial ovarian cancer.

Detailed Description

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Conditions

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Cancer Non Small Cell Lung Cancer Epithelial Ovarian Cancer

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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AZD0530 + carboplatin and paclitaxel

AZD0530 in combination with carboplatin and paclitaxel

Group Type EXPERIMENTAL

AZD0530

Intervention Type DRUG

film coated tablet, PO, daily

Carboplatin

Intervention Type DRUG

intravenous, 3 weeks

paclitaxel

Intervention Type DRUG

intravenous, 3 weeks

Interventions

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AZD0530

film coated tablet, PO, daily

Intervention Type DRUG

Carboplatin

intravenous, 3 weeks

Intervention Type DRUG

paclitaxel

intravenous, 3 weeks

Intervention Type DRUG

Other Intervention Names

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Paraplatin Taxol

Eligibility Criteria

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Inclusion Criteria

* Japanese patients with non small cell lung cancer or epithelial ovarian cancer
* Must be suitable for treatment with carboplatin and paclitaxel
* Relatively good overall health other than cancer

Exclusion Criteria

* Poor bone marrow function (not producing enough blood cells).
* Poor liver or kidney function.
* Patients unable to discontinue drugs known to be potent inhibitors or inducers of CYP3A4 within 2 weeks prior to registration
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Mary Stuart

Role: STUDY_DIRECTOR

AstraZeneca

Takashi Seto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Hospital Organisation Kyushu Cancer Centre

Naoyuki Nogami, MD

Role: PRINCIPAL_INVESTIGATOR

National Hospital Organisation Shikoku Cancer Centre

Locations

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Research Site

Matsuyama, Ehime, Japan

Site Status

Research Site

Fukuoka, Fukuoka, Japan

Site Status

Countries

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Japan

Other Identifiers

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D8180C00020

Identifier Type: -

Identifier Source: org_study_id

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