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


Tracking Information

Start Date  ICMJEJuly 2007
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)		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 ]
Original Primary Outcome Measures ICMJE 
 (submitted: July 12, 2007)
  • 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) ]
  • To determine the safety profile of Maxy-G34 when administered in conjunction with up to 6 cycles of TAC chemotherapy [ Time Frame: over all 6 cycles of TAC chemotherapy (approximately 18 weeks) ]
Change HistoryComplete list of historical versions of study NCT00501332 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: December 19, 2007)
  • 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 ]
Original Secondary Outcome Measures ICMJE 
 (submitted: July 12, 2007)
  • 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) ]
  • 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) ]

Descriptive Information

Brief Title  ICMJEEvaluation of Maxy-G34 in Breast Cancer Patients Treated With TAC (Docetaxel, Adriamycin, Cyclophosphamide) Chemotherapy
Official Title  ICMJEA 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.
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.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Chemotherapy-Induced Neutropenia
  • Breast Cancer
Intervention  ICMJEBiological: Maxy-G34
Maxy-G34 will be administered by subcutaneous injection during each of 6 TAC chemotherapy cycles.
Other Name: pegylated recombinant human G-CSF
Study Arms / Comparison Groups2: Active Comparator
Intervention: Biological: Maxy-G34

Recruitment Information

Estimated Enrollment  ICMJE30
Completion Date 
Primary Completion Date 
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Doris Apt650-298-5367Doris.Apt@maxygen.com
Location Countries  ICMJEPoland,   Romania,   Russian Federation,   Ukraine

Administrative Information

NCT ID  ICMJENCT00501332
Responsible PartySantosh Vetticaden, MD. Chief Medical Officer., Maxygen, Inc.
Study ID Numbers  ICMJEMP-CL-30166, EUDRACT No.: 2006-006565-16, PAREXEL 84728
Study Sponsor  ICMJEMaxygen Holdings Ltd.
Collaborators  ICMJE
  • Maxygen ApS
  • Maxygen, Inc.
  • Parexel
Investigators  ICMJE
Study Director:Santosh Vetticaden, MDMaxygen, Inc.
Information Provided ByMaxygen Holdings Ltd.