Clinical trial NCT00501332: Evaluation of Maxy-G34 in Breast Cancer Patients Treated With TAC (Docetaxel, Adriamycin, Cyclophosphamide) Chemotherapy
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chemotherapy-Induced Neutropenia
Breast Cancer
Keywords: neutropenia
breast
cancer
chemotherapy
Lead sponsor: Maxygen Holdings Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Maxygen ApS
name: Maxygen, Inc.
name: Parexel
First posted: 2007-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycle 1.
timeFrame: over 1 cycle of TAC chemotherapy (approximately 3 weeks)
Secondary outcomes:
measure: To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycles 2-6.
timeFrame: over cycles 2-6 of TAC chemotherapy (approximately from weeks 4-18)
measure: To determine the incidence of grade 4 neutropenia after administration of each of the 6 doses of Maxy-G34.
timeFrame: over all 6 cycles of TAC chemotherapy (approximately 18 weeks)
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
city: Gdansk
country: Poland
city: Lublin
country: Poland
city: Alba-Iulia
country: Romania
city: Bucuresti
country: Romania
city: Jud. Bacau
country: Romania
city: Suceava
country: Romania
city: Timisoara
country: Romania
city: Leningrad region
country: Russian Federation
city: Moscow Area
country: Russian Federation
city: Moscow
country: Russian Federation
city: Ryazan
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Dnipropetrovsk
country: Ukraine
city: Uzhorod
country: Ukraine
Study officials:
affiliation: Maxygen, Inc.
name: Santosh Vetticaden, MD
role: STUDY_DIRECTOR
References: