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Evaluation of Maxy-G34 in Breast Cancer Patients Treated With TAC (Docetaxel, Adriamycin, Cyclophosphamide) Chemotherapy

NCT ID: NCT00501332

Last Updated: 2007-12-24

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Brief Summary

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This is an investigation of the safety and efficacy of Maxy-G34 in breast cancer patients treated with TAC chemotherapy. Maxy-G34 will be given as a single injection during each cycle of chemotherapy, for a planned total of six chemotherapy cycles.

Detailed Description

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Conditions

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Chemotherapy-Induced Neutropenia Breast Cancer

Keywords

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neutropenia breast cancer chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2

Group Type ACTIVE_COMPARATOR

Maxy-G34

Intervention Type BIOLOGICAL

Maxy-G34 will be administered by subcutaneous injection during each of 6 TAC chemotherapy cycles.

Interventions

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Maxy-G34

Maxy-G34 will be administered by subcutaneous injection during each of 6 TAC chemotherapy cycles.

Intervention Type BIOLOGICAL

Other Intervention Names

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pegylated recombinant human G-CSF

Eligibility Criteria

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Inclusion Criteria

1. Males and females at least 18 years of age
2. Diagnosis of high-risk stage I, II or IIIa breast cancer suitable for adjuvant TAC chemotherapy as based on investigator judgment
3. Candidates for TAC chemotherapy, and no prior treatment with anthracyclines

Exclusion Criteria

1. Received chemotherapy within last 3 month prior to screening, or expected to receive any chemotherapy other than TAC and / or immunotherapy between screening and 30 days after last planned study drug administration
2. Any clinically significant findings on history or examination that, in the opinion of the investigator, would preclude administration of TAC chemotherapy in the full dose, including abnormal liver function, inadequate cardiac function or clinically significant cardiac disease, neuropathy or other disease
3. Prior bone marrow or peripheral blood hematopoietic stem cell transplant
4. Any active cancer or history of prior malignancy within the last 5 years except carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin or any surgically cured malignancy diagnosed 5 years or more before diagnosis of breast cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maxygen ApS

INDUSTRY

Sponsor Role collaborator

Maxygen, Inc.

INDUSTRY

Sponsor Role collaborator

Parexel

INDUSTRY

Sponsor Role collaborator

Maxygen Holdings Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Maxygen, Inc.

Principal Investigators

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Santosh Vetticaden, MD

Role: STUDY_DIRECTOR

Maxygen, Inc.

Locations

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Bydgoszcz, , Poland

Site Status RECRUITING

Gdansk, , Poland

Site Status RECRUITING

Lublin, , Poland

Site Status RECRUITING

Alba Iulia, , Romania

Site Status ACTIVE_NOT_RECRUITING

Bucharest, , Romania

Site Status ACTIVE_NOT_RECRUITING

Jud. Bacau, , Romania

Site Status RECRUITING

Suceava, , Romania

Site Status RECRUITING

Timișoara, , Romania

Site Status RECRUITING

Leningrad Region, , Russia

Site Status ACTIVE_NOT_RECRUITING

Moscow, , Russia

Site Status ACTIVE_NOT_RECRUITING

Moscow Area, , Russia

Site Status RECRUITING

Ryazan, , Russia

Site Status ACTIVE_NOT_RECRUITING

Saint Petersburg, , Russia

Site Status ACTIVE_NOT_RECRUITING

Dnipropetrovsk, , Ukraine

Site Status RECRUITING

Uzhhorod, , Ukraine

Site Status RECRUITING

Countries

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Poland Romania Russia Ukraine

Central Contacts

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Doris Apt

Role: CONTACT

Phone: 650-298-5367

Email: [email protected]

Other Identifiers

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EUDRACT No.: 2006-006565-16

Identifier Type: -

Identifier Source: secondary_id

PAREXEL 84728

Identifier Type: -

Identifier Source: secondary_id

MP-CL-30166

Identifier Type: -

Identifier Source: org_study_id