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

December 19, 2007 updated by: Maxygen Holdings Ltd.

A Phase IIa, Open Label, Controlled, Dose Ranging Study of Maxy-G34 as an Adjunct to TAC Chemotherapy in High-Risk Patients With Stage I, II, or IIIa Breast Cancer.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Bydgoszcz, Poland
        • Recruiting
      • Gdansk, Poland
        • Recruiting
      • Lublin, Poland
        • Recruiting
  • Romania
      • Alba-Iulia, Romania
        • Active, not recruiting
      • Bucuresti, Romania
        • Active, not recruiting
      • Jud. Bacau, Romania
        • Recruiting
      • Suceava, Romania
        • Recruiting
      • Timisoara, Romania
        • Recruiting
  • Russian Federation
      • Leningrad region, Russian Federation
        • Active, not recruiting
      • Moscow, Russian Federation
        • Active, not recruiting
      • Moscow Area, Russian Federation
        • Recruiting
      • Ryazan, Russian Federation
        • Active, not recruiting
      • St. Petersburg, Russian Federation
        • Active, not recruiting
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Recruiting
      • Uzhorod, Ukraine
        • Recruiting

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key 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

Key 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Biological: Maxy-G34
Maxy-G34 will be administered by subcutaneous injection during each of 6 TAC chemotherapy cycles.
Other Names:
  • pegylated recombinant human G-CSF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycle 1.
Time Frame: over 1 cycle of TAC chemotherapy (approximately 3 weeks)
over 1 cycle of TAC chemotherapy (approximately 3 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycles 2-6.
Time Frame: over cycles 2-6 of TAC chemotherapy (approximately from weeks 4-18)
over cycles 2-6 of TAC chemotherapy (approximately from weeks 4-18)
To determine the incidence of grade 4 neutropenia after administration of each of the 6 doses of Maxy-G34.
Time Frame: over all 6 cycles of TAC chemotherapy (approximately 18 weeks)
over all 6 cycles of TAC chemotherapy (approximately 18 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maxygen Holdings Ltd.

Collaborators

Parexel
Maxygen ApS
Maxygen, Inc.

Investigators

  • Study Director: Santosh Vetticaden, MD, Maxygen, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Study Registration Dates

First Submitted

July 12, 2007

First Submitted That Met QC Criteria

July 12, 2007

First Posted (ESTIMATE)

July 16, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2007

Last Update Submitted That Met QC Criteria

December 19, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-CL-30166
  • EUDRACT No.: 2006-006565-16
  • PAREXEL 84728

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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