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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00501332
Recruitment Status : Unknown
Verified December 2007 by Maxygen Holdings Ltd..
Recruitment status was:  Recruiting
First Posted : July 16, 2007
Last Update Posted : December 24, 2007
Maxygen ApS
Maxygen, Inc.
Information provided by:
Maxygen Holdings Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chemotherapy-Induced Neutropenia Breast Cancer Biological: Maxy-G34 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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 Name: pegylated recombinant human G-CSF

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00501332

Contact: Doris Apt 650-298-5367

Bydgoszcz, Poland
Gdansk, Poland
Lublin, Poland
Active, not recruiting
Alba-Iulia, Romania
Active, not recruiting
Bucuresti, Romania
Jud. Bacau, Romania
Suceava, Romania
Timisoara, Romania
Russian Federation
Active, not recruiting
Leningrad region, Russian Federation
Moscow Area, Russian Federation
Active, not recruiting
Moscow, Russian Federation
Active, not recruiting
Ryazan, Russian Federation
Active, not recruiting
St. Petersburg, Russian Federation
Dnipropetrovsk, Ukraine
Uzhorod, Ukraine
Sponsors and Collaborators
Maxygen Holdings Ltd.
Maxygen ApS
Maxygen, Inc.
Study Director: Santosh Vetticaden, MD Maxygen, Inc.

Responsible Party: Santosh Vetticaden, MD. Chief Medical Officer., Maxygen, Inc. Identifier: NCT00501332     History of Changes
Other Study ID Numbers: MP-CL-30166
EUDRACT No.: 2006-006565-16
First Posted: July 16, 2007    Key Record Dates
Last Update Posted: December 24, 2007
Last Verified: December 2007

Keywords provided by Maxygen Holdings Ltd.:

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Leukocyte Disorders
Hematologic Diseases