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

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00501332
• Other study ID #: MP-CL-30166
• Secondary ID: EUDRACT No.: 200
• Status: Recruiting
• Phase: Phase 2
• First received: July 12, 2007
• Last updated: December 19, 2007
• Start date: July 2007

Study information

• Verified date: December 2007
• Source: Maxygen Holdings Ltd.
• Contact: Doris Apt
• Phone: 650-298-5367
• Email: Doris.Apt[@]maxygen.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRomania: National Medicines AgencyPoland: Ministry of HealthUkraine: State Pharmacological Center - Ministry of HealthRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapy-Induced Neutropenia
• Neutropenia

Intervention

Biological:
• Maxy-G34
Maxy-G34 will be administered by subcutaneous injection during each of 6 TAC chemotherapy cycles.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Maxygen Holdings Ltd.	Maxygen ApS, Maxygen, Inc., Parexel

Countries where clinical trial is conducted

Poland,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycle 1.		over 1 cycle of TAC chemotherapy (approximately 3 weeks)	Yes
Secondary	To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycles 2-6.		over cycles 2-6 of TAC chemotherapy (approximately from weeks 4-18)	Yes
Secondary	To determine the incidence of grade 4 neutropenia after administration of each of the 6 doses of Maxy-G34.		over all 6 cycles of TAC chemotherapy (approximately 18 weeks)	Yes