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

Primary Purpose

Chemotherapy-Induced Neutropenia, Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Maxy-G34
Sponsored by
Maxygen Holdings Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-Induced Neutropenia focused on measuring neutropenia, breast, cancer, chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

2

Arm Description

Outcomes

Primary Outcome Measures

To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycle 1.

Secondary Outcome Measures

To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycles 2-6.
To determine the incidence of grade 4 neutropenia after administration of each of the 6 doses of Maxy-G34.

Full Information

First Posted
July 12, 2007
Last Updated
December 19, 2007
Sponsor
Maxygen Holdings Ltd.
Collaborators
Maxygen ApS, Maxygen, Inc., Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT00501332
Brief Title
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

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Maxygen Holdings Ltd.
Collaborators
Maxygen ApS, Maxygen, Inc., Parexel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-Induced Neutropenia, Breast Cancer
Keywords
neutropenia, breast, cancer, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Maxy-G34
Other Intervention Name(s)
pegylated recombinant human G-CSF
Intervention Description
Maxy-G34 will be administered by subcutaneous injection during each of 6 TAC chemotherapy cycles.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Males and females at least 18 years of age Diagnosis of high-risk stage I, II or IIIa breast cancer suitable for adjuvant TAC chemotherapy as based on investigator judgment Candidates for TAC chemotherapy, and no prior treatment with anthracyclines Key Exclusion Criteria: 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 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 Prior bone marrow or peripheral blood hematopoietic stem cell transplant 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doris Apt
Phone
650-298-5367
Email
Doris.Apt@maxygen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santosh Vetticaden, MD
Organizational Affiliation
Maxygen, Inc.
Official's Role
Study Director
Facility Information:
City
Bydgoszcz
Country
Poland
Individual Site Status
Recruiting
City
Gdansk
Country
Poland
Individual Site Status
Recruiting
City
Lublin
Country
Poland
Individual Site Status
Recruiting
City
Alba-Iulia
Country
Romania
Individual Site Status
Active, not recruiting
City
Bucuresti
Country
Romania
Individual Site Status
Active, not recruiting
City
Jud. Bacau
Country
Romania
Individual Site Status
Recruiting
City
Suceava
Country
Romania
Individual Site Status
Recruiting
City
Timisoara
Country
Romania
Individual Site Status
Recruiting
City
Leningrad region
Country
Russian Federation
Individual Site Status
Active, not recruiting
City
Moscow Area
Country
Russian Federation
Individual Site Status
Recruiting
City
Moscow
Country
Russian Federation
Individual Site Status
Active, not recruiting
City
Ryazan
Country
Russian Federation
Individual Site Status
Active, not recruiting
City
St. Petersburg
Country
Russian Federation
Individual Site Status
Active, not recruiting
City
Dnipropetrovsk
Country
Ukraine
Individual Site Status
Recruiting
City
Uzhorod
Country
Ukraine
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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