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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Maxygen Holdings Ltd..
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Maxygen ApS
Maxygen, Inc.
Parexel
Information provided by:
Maxygen Holdings Ltd.
ClinicalTrials.gov Identifier:
NCT00501332
First received: July 12, 2007
Last updated: December 19, 2007
Last verified: December 2007
  Purpose

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 Intervention Phase
Chemotherapy-Induced Neutropenia
Breast Cancer
Biological: Maxy-G34
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Maxygen Holdings Ltd.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: July 2007
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501332

Contacts
Contact: Doris Apt 650-298-5367 Doris.Apt@maxygen.com

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

No publications provided

Responsible Party: Santosh Vetticaden, MD. Chief Medical Officer., Maxygen, Inc.
ClinicalTrials.gov Identifier: NCT00501332     History of Changes
Other Study ID Numbers: MP-CL-30166, EUDRACT No.: 2006-006565-16, PAREXEL 84728
Study First Received: July 12, 2007
Last Updated: December 19, 2007
Health Authority: United States: Food and Drug Administration
Romania: National Medicines Agency
Poland: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
Russia: Ministry of Health of the Russian Federation

Keywords provided by Maxygen Holdings Ltd.:
neutropenia
breast
cancer
chemotherapy

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

ClinicalTrials.gov processed this record on October 20, 2014