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
Recruitment status was Recruiting
Sponsor:
Maxygen Holdings Ltd.
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
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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:
Drug Information available for:
Triamcinolone diacetate
Triamcinolone acetonide
Triamcinolone
Triamcinolone hexacetonide
U.S. FDA Resources
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:
- 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
Contacts and Locations
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 Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013