Metastatic Breast CancerPhase 2NCT00265655
Satraplatin for Patients With Metastatic Breast Cancer (MBC)
A Phase 2 study testing Satraplatin in people with Metastatic Breast Cancer, run by Agennix at 1 site in United States.
Trial summary
To determine the objective response rate (ORR) of oral satraplatin in patients with Metastatic Breast Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Satraplatin
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Feb 2008
- 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
- Has cytologically or pathologically confirmed breast cancer that is metastatic
- Must have had prior HerceptinÒ therapy if patient has HER2+ (overexpressing) breast cancer. HER2 is considered overexpressed if it is 3+ by IHC or if the gene is amplified by Flourescence in situ hybridization (FISH)
- Has had no more than 1 prior chemotherapy regimen for MBC
- Has had no prior platinum-based therapy
- Has an ECOG Performance Status (PS) 0-2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II of Oral Satraplatin in Patients With Metastatic Breast Cancer (MBC)
To determine the objective response rate (ORR) of oral satraplatin in patients with Metastatic Breast Cancer.
Read the detailed description
This is a Phase II open label, nonrandomized study for patients with metastatic breast cancer.
WHAT IS SATRAPLATIN:
Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Satraplatin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SatraplatinDrug
Patients will receive 80mg/m2 Satraplatin on Days 1-5 of Cycles 1 and 2. A cycle consists of 21 days.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the objective response rate (ORR) of oral satraplatin in patients with metastatic breast cancer
Measured: 1 year
Secondary outcomes (5)
To determine duration of response
Measured: 6 weeks
To determine progression-free survival (PFS)
Measured: 1 year
To determine 1-year survival
Measured: 1 year
To evaluate the toxicities of satraplatin in MBC patients
Measured: 6 weeks
In patients with nonmeasurable MBC, to assess the clinical utility of serum CA27.29 (or CA15.3) and circulating tumor cells as predictors of time to disease progression
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2005 (estimated)
- Study startNov 2005
- Primary completionJan 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agennix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joyce O'Shaughnessy, MD, Principal investigator, US Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265655
- Sponsor's protocol ID
- Protocol 05-021
- Status last verified
- Mar 2012
- First submitted
- 1 Dec 2005
- Last updated
- 28 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II of Oral Satraplatin in Patients With Metastatic Breast Cancer (MBC)
- ClinicalTrials.gov ID
- NCT00265655
- Acronym / sponsor ID
- Protocol 05-021
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AgennixIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 15 Dec 2005 (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.
To determine the objective response rate (ORR) of oral satraplatin in patients with Metastatic Breast Cancer.
Detailed description
This is a Phase II open label, nonrandomized study for patients with metastatic breast cancer.
WHAT IS SATRAPLATIN:
Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| SatraplatinPatients will receive 80mg/m2 Satraplatin on Days 1-5 of Cycles 1 and 2. A cycle consists of 21 days. | Drug | – |
Primary outcome
To determine the objective response rate (ORR) of oral satraplatin in patients with metastatic breast cancer
Time frame: 1 year
5 secondary outcomes
To determine duration of response
Time frame: 6 weeks
To determine progression-free survival (PFS)
Time frame: 1 year
To determine 1-year survival
Time frame: 1 year
To evaluate the toxicities of satraplatin in MBC patients
Time frame: 6 weeks
In patients with nonmeasurable MBC, to assess the clinical utility of serum CA27.29 (or CA15.3) and circulating tumor cells as predictors of time to disease progression
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2012.
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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.
Joyce O'Shaughnessy, MD principal investigator
US Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Satraplatin in people with Metastatic Breast Cancer, run by Agennix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 28 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the objective response rate (ORR) of oral satraplatin in patients with metastatic breast cancer (time frame: 1 year). 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 28 Mar 2012.