Chemotherapy-Induced NeutropeniaPhase 2NCT00501332
Evaluation of Maxy-G34 in Breast Cancer Patients Treated With TAC (Docetaxel, Adriamycin, Cyclophosphamide) Chemotherapy
A Phase 2 study testing Maxy-G34 in people with Chemotherapy-Induced Neutropenia and Breast Cancer, run by Maxygen Holdings Ltd. at 15 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Neutropenia, Breast Cancer
- What is being tested?
- Maxy-G34
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 15 sitesin 4 countries
- Study dates
- Jul 2007to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
Romania5 sites, 3 recruiting
- Active, not recruiting
Study site
Alba Iulia
- Active, not recruiting
Study site
Bucharest
- Recruiting
Study site
Jud. Bacau
- Recruiting
Study site
Suceava
- Recruiting
Study site
Timișoara
Russia5 sites, 1 recruiting
- Active, not recruiting
Study site
Leningrad Region
- Active, not recruiting
Study site
Moscow
- Recruiting
Study site
Moscow Area
- Active, not recruiting
Study site
Ryazan
- Active, not recruiting
Study site
Saint Petersburg
Poland3 sites, 3 recruiting
- Recruiting
Study site
Bydgoszcz
- Recruiting
Study site
Gdansk
- Recruiting
Study site
Lublin
Ukraine2 sites, 2 recruiting
- Recruiting
Study site
Dnipropetrovsk
- Recruiting
Study site
Uzhhorod
About this study
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.
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.
- Conditions
- Chemotherapy-Induced Neutropenia, Breast Cancer
- Being tested
- Maxy-G34
- Keywords
- neutropenia, breast, cancer, chemotherapy
- Medical subject headings
- Breast Neoplasms, Neutropenia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxy-G34Biological
Also called pegylated recombinant human G-CSF
Maxy-G34 will be administered by subcutaneous injection during each of 6 TAC chemotherapy cycles.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Not described Receives: Biological: Maxy-G34 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycle 1.
Measured: over 1 cycle of TAC chemotherapy (approximately 3 weeks)
Secondary outcomes (2)
To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycles 2-6.
Measured: 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.
Measured: over all 6 cycles of TAC chemotherapy (approximately 18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxygen Holdings Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maxygen ApS, Maxygen, Inc., Parexel
- Investigators
- Santosh Vetticaden, MD, Study director, Maxygen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501332
- Sponsor's protocol ID
- MP-CL-30166
- Other IDs
- EUDRACT No.: 2006-006565-16, PAREXEL 84728
- Status last verified
- Dec 2007
- First submitted
- 12 Jul 2007
- Last updated
- 24 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00501332
- Acronym / sponsor ID
- MP-CL-30166
- Conditions
- Chemotherapy-Induced Neutropenia, Breast Cancer
- Keywords
- neutropenia, breast, cancer, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maxygen Holdings Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Maxygen ApS, Maxygen, Inc., Parexel
- Study start
- Jul 2007
- First posted
- 16 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Biological: Maxy-G34 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maxy-G34Also: pegylated recombinant human G-CSFMaxy-G34 will be administered by subcutaneous injection during each of 6 TAC chemotherapy cycles. | Biological | 2 |
Primary outcome
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)
2 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santosh Vetticaden, MD study director
Maxygen, Inc.
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Maxy-G34 in people with Chemotherapy-Induced Neutropenia and Breast Cancer, run by Maxygen Holdings Ltd. at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Romania, Russia, Poland, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doris Apt (650-298-5367, Doris.Apt@maxygen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2007.