Neoplasms, BreastPhase 2NCT00062686
GW572016 For Treatment Of Refractory Metastatic Breast Cancer
A Phase 2 study testing GW572016 in people with Neoplasms, Breast, run by GlaxoSmithKline at 7 sites in 4 countries.
Trial summary
This study was designed to determine the efficacy of an oral dual kinase inhibitor for the treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a refractory patient population. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neoplasms, Breast
- What is being tested?
- GW572016
- How many people
- 200 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Nov 2003to Feb 2005
- 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
- Signed Informed Consent.
- Histologically confirmed Stage IIIb or IV breast cancer.
- Refractory breast cancer defined as progression in the metastatic setting after prior therapy with anthracyclines, taxanes and capecitibine.
- Subjects with documented ErbB2 tumor overexpression must have received at least 6 cycles of trastuzumab.
- Documented disease progression of the most recent treatment is required.
- Archived tumor tissue available for testing.
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- Measurable lesions according to Response Evaluation Criteria In Solid Tumors (RECIST).
- At least 3 weeks since prior cancer therapies except for trastuzumab which must be discontinued at least 2 weeks prior to the beginning of study drug.
- Bisphosphonate therapy initiated prior to study entry is allowed, however, initiation of bisphosphonates following study entry is not allowed.
- Able to swallow and retain oral medication.
- Cardiac ejection fraction within the institutional normal range as measured by echocardiogram or MUGA (Multiple Gated Acquisition) scan.
- Adequate kidney and liver function.
- Adequate bone marrow function.
Who cannot join
- Pregnant or lactating.
- Copies of nadir scans and/or photographs of the tumor prior to disease progression as well as scans documenting disease progression are not available for review.
- Malabsorption syndrome, ulcerative colitis, disease significantly affecting gastrointestinal function or resection of the stomach or small bowel.
- History of other malignancy.
- Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
- Active or uncontrolled infection.
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- Known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure.
- Known history of or clinical evidence of leptomeningeal carcinomatosis.
- Active infection.
- Concurrent cancer therapy or investigational therapy.
- Use of oral or IV steroids.
- Unresolved or unstable serious toxicity from prior therapy.
- Prior treatment with an ErbB1 and/or ERbB2 inhibitor other than trastuzumab.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United Kingdom4 sites
GSK Investigational Site
Bebington, Wirral, CH63 4JY
GSK Investigational Site
London, SW3 6JJ
GSK Investigational Site
Manchester, M20 4BX
GSK Investigational Site
Sutton, Surrey, SM2 5PT
Argentina1 site
GSK Investigational Site
Buenos Aires, Buenos Aires, C1455BWU
About this study
Official title: An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving HERCEPTIN-Containing Regimens
This study was designed to determine the efficacy of an oral dual kinase inhibitor for the treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a refractory patient population.
- Conditions
- Neoplasms, Breast
- Being tested
- GW572016
- Keywords
- Lapatinib, Metastatic Breast Cancer, HERCEPTIN refractory
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW572016Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate
Secondary outcomes (1)
clinical benefit rate time to progression 4 and 6 month progression free survival overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2003 (estimated)
- Study startNov 2003
- Primary completionFeb 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, BreastStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062686
- Sponsor's protocol ID
- EGF20008
- Status last verified
- Apr 2015
- First submitted
- 11 Jun 2003
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving HERCEPTIN-Containing Regimens
- ClinicalTrials.gov ID
- NCT00062686
- Acronym / sponsor ID
- EGF20008
- Conditions
- Neoplasms, Breast
- Keywords
- Lapatinib, Metastatic Breast Cancer, HERCEPTIN refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 12 Jun 2003 (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 study was designed to determine the efficacy of an oral dual kinase inhibitor for the treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a refractory patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed Informed Consent.
- Histologically confirmed Stage IIIb or IV breast cancer.
- Refractory breast cancer defined as progression in the metastatic setting after prior therapy with anthracyclines, taxanes and capecitibine.
- Subjects with documented ErbB2 tumor overexpression must have received at least 6 cycles of trastuzumab.
- Documented disease progression of the most recent treatment is required.
Key exclusion criteria (13 listed)
- Pregnant or lactating.
- Copies of nadir scans and/or photographs of the tumor prior to disease progression as well as scans documenting disease progression are not available for review.
- Malabsorption syndrome, ulcerative colitis, disease significantly affecting gastrointestinal function or resection of the stomach or small bowel.
- History of other malignancy.
- Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
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 |
|---|---|---|
| GW572016 | Drug | – |
Primary outcome
Tumor response rate
1 secondary outcome
clinical benefit rate time to progression 4 and 6 month progression free survival overall survival
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 15 Apr 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.
GSK Clinical Trials study director
GlaxoSmithKline
7 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 GW572016 in people with Neoplasms, Breast, run by GlaxoSmithKline at 7 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 13 inclusion and 13 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: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom, Argentina, France, Germany. 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?
Tumor response rate. 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 15 Apr 2015.