Breast CancerPhase 2NCT00780000
Clinical Trial of Intravenous Alvespimycin in Patients With Her2 Positive Breast Cancer
A Phase 2 study testing Alvespimycin in people with Breast Cancer, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to determine the anti-tumor activity (via objective response rate) of alvespimycin in patients with breast cancer who have not previously received trastuzumab (except as adjuvant therapy). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Alvespimycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Jun 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- KPS performance status of >= 80% ("normal activity with effort")
- Metastatic breast cancer with Her2 amplification by FISH or 3+ Her2 overexpression by immunohistochemistry ("IHC")
- Must have received no more than one prior cytotoxic chemotherapy regimen in the metastatic setting
- Measurable disease by RECIST Criteria
Who cannot join
- Received prior lapatinib, an investigational ErbB-2 and/or an investigational EGFR dual tyrosine kinase inhibitors
- Administration of any other chemotherapy, biological, immunotherapy or investigational agent within 14 days prior to receipt of study medication
- Pregnant or breast-feeding women. Known CNS metastases, unless treated and without clinically significant neurological deficits
- Moderately severe dry eye
- Congestive heart failure, or a left ventricular ejection fraction
- Myocardial infarction or active ischemic heart disease within 12 months prior to study drug administration
- Previous malignancies unless free of recurrence for at least 5 years
About this study
Official title: Phase 2 Clinical Trial of Intravenous Alvespimycin [KOS-1022] in Patients With Her2 Positive Breast Cancer
The purpose of this study is to determine the anti-tumor activity (via objective response rate) of alvespimycin in patients with breast cancer who have not previously received trastuzumab (except as adjuvant therapy).
- Conditions
- Breast Cancer
- Being tested
- Alvespimycin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlvespimycinDrug
Solution, IV, Alvespimycin 80 mg/m2, Weekly one hour infusion Days 1, 8, and 15, every 4 weeks thereafter until disease progression or DLT
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Not described Receives: Drug: Alvespimycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumor response rate (either RECIST or WHO complete response, partial response or minor response) confirmed by CT and MRI as the preferred methods for tumor assessments and Chest x-ray is acceptable for pulmonary lesions
(all patients were off study by June 2008)
Measured: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Secondary outcomes (14)
Adverse Events assessed according to the NCI CTCAE (v 3.0) grading system
(all patients were off study by June 2008)
Measured: Within 28 days prior to the start of treatment, and for 167 days
Laboratory tests assessed according to the NCI CTCAE (v 3.0) grading system
Measured: Within 10 days prior to Cycle 1/1st infusion; within 48 hours of infusion (Cycle 1/Weeks 2/3/4 and Cycle 2+/Week3), or within 72 hours prior to infusion (Cycle 2+/Week 1)
Vital signs
(all patients were off study by June 2008)
Measured: Within 28 days prior to the start of treatment, Day1 of Weeks 1, 2, and 3 of Cycle 1 (4 weeks long), and prior to each 4-week cycle starting with Cycle 2, for 167 days
Karnofsky Performance Status
(all patients were off study by June 2008)
Measured: Within 28 days prior to the start of treatment, prior to each 4-week cycle starting with Cycle 2, for 167 days
Ocular testing
(all patients were off study by June 2008)
Measured: Within 28 days prior to the start of treatment, Cycle 1/Day 10 (3 days +/- 1 day following the 2nd infusion in the first cycle of therapy), prior to Cycle 2, if clinically indicated thereafter, for 167 days
Kaplan-Meier estimate of time to progression
(all patients were off study by June 2008)
Measured: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Time to progression on the patient's prior cytotoxic chemotherapy compared to the patient's time to progression on alvespimycin
(all patients were off study by June 2008)
Measured: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Kaplan-Meier estimate of progression-free survival
(all patients were off study by June 2008)
Measured: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Kaplan-Meier estimate of time to response
(all patients were off study by June 2008)
Measured: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Kaplan-Meier estimate of duration of response
(all patients were off study by June 2008)
Measured: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Kaplan-Meier estimate of time to treatment failure
(all patients were off study by June 2008)
Measured: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Kaplan-Meier estimate of overall survival
(all patients were off study by June 2008)
Measured: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Changes in tumor markers
Measured: Within 28 days prior to the start of treatment, Prior to each 4-week cycle starting with Cycle 2, for 167 days
Histopathological and molecular profile of responding and non-responding patients using paraffin-embedded surgical specimens
Measured: Specimens were obtained within 28 days prior to the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780000
- Sponsor's protocol ID
- CA201-002
- Other IDs
- 2007-003121-25, KDG-201
- Status last verified
- Oct 2015
- First submitted
- 23 Oct 2008
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Clinical Trial of Intravenous Alvespimycin [KOS-1022] in Patients With Her2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00780000
- Acronym / sponsor ID
- CA201-002
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 24 Oct 2008 (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.
The purpose of this study is to determine the anti-tumor activity (via objective response rate) of alvespimycin in patients with breast cancer who have not previously received trastuzumab (except as adjuvant therapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: Alvespimycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- KPS performance status of >= 80% ("normal activity with effort")
- Metastatic breast cancer with Her2 amplification by FISH or 3+ Her2 overexpression by immunohistochemistry ("IHC")
- Must have received no more than one prior cytotoxic chemotherapy regimen in the metastatic setting
- Measurable disease by RECIST Criteria
Key exclusion criteria (7 listed)
- Received prior lapatinib, an investigational ErbB-2 and/or an investigational EGFR dual tyrosine kinase inhibitors
- Administration of any other chemotherapy, biological, immunotherapy or investigational agent within 14 days prior to receipt of study medication
- Pregnant or breast-feeding women. Known CNS metastases, unless treated and without clinically significant neurological deficits
- Moderately severe dry eye
- Congestive heart failure, or a left ventricular ejection fraction
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 |
|---|---|---|
| AlvespimycinSolution, IV, Alvespimycin 80 mg/m2, Weekly one hour infusion Days 1, 8, and 15, every 4 weeks thereafter until disease progression or DLT | Drug | A1 |
Primary outcome
Objective tumor response rate (either RECIST or WHO complete response, partial response or minor response) confirmed by CT and MRI as the preferred methods for tumor assessments and Chest x-ray is acceptable for pulmonary lesions
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
(all patients were off study by June 2008)
14 secondary outcomes
Adverse Events assessed according to the NCI CTCAE (v 3.0) grading system
Time frame: Within 28 days prior to the start of treatment, and for 167 days
Laboratory tests assessed according to the NCI CTCAE (v 3.0) grading system
Time frame: Within 10 days prior to Cycle 1/1st infusion; within 48 hours of infusion (Cycle 1/Weeks 2/3/4 and Cycle 2+/Week3), or within 72 hours prior to infusion (Cycle 2+/Week 1)
Vital signs
Time frame: Within 28 days prior to the start of treatment, Day1 of Weeks 1, 2, and 3 of Cycle 1 (4 weeks long), and prior to each 4-week cycle starting with Cycle 2, for 167 days
Karnofsky Performance Status
Time frame: Within 28 days prior to the start of treatment, prior to each 4-week cycle starting with Cycle 2, for 167 days
Ocular testing
Time frame: Within 28 days prior to the start of treatment, Cycle 1/Day 10 (3 days +/- 1 day following the 2nd infusion in the first cycle of therapy), prior to Cycle 2, if clinically indicated thereafter, for 167 days
Kaplan-Meier estimate of time to progression
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Time to progression on the patient's prior cytotoxic chemotherapy compared to the patient's time to progression on alvespimycin
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Kaplan-Meier estimate of progression-free survival
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Kaplan-Meier estimate of time to response
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Kaplan-Meier estimate of duration of response
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Kaplan-Meier estimate of time to treatment failure
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Kaplan-Meier estimate of overall survival
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Changes in tumor markers
Time frame: Within 28 days prior to the start of treatment, Prior to each 4-week cycle starting with Cycle 2, for 167 days
Histopathological and molecular profile of responding and non-responding patients using paraffin-embedded surgical specimens
Time frame: Specimens were obtained within 28 days prior to the start of treatment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alvespimycin in people with Breast Cancer, run by Bristol-Myers Squibb.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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?
Objective tumor response rate (either RECIST or WHO complete response, partial response or minor response) confirmed by CT and MRI as the preferred methods for tumor assessments and Chest x-ray is acceptable for pulmonary lesions (time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)). 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 4 Nov 2015.