Neoplasms, BreastPhase 1NCT00371488
GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer
A Phase 1 study testing GW572016 oral tablets in people with Neoplasms, Breast, run by GlaxoSmithKline at 2 sites in Japan.
Trial summary
This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best) doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and trastuzumab. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Neoplasms, Breast
- What is being tested?
- GW572016 oral tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesJapan
- Study dates
- 6 Apr 2006to 10 Dec 2007
- Phase
- Phase 1
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed breast cancer who have received prior trastuzumab.
- Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
- Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.
Who cannot join
- Patients with certain heart problems.
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
GSK Investigational Site
Saitama, 350-1298
GSK Investigational Site
Tokyo, 135-8550
About this study
Official title: Phase I Study of Lapatinib in Combination With Trastuzumab
This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best) doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and trastuzumab.
- Conditions
- Neoplasms, Breast
- Being tested
- GW572016 oral tablets
- Keywords
- ErbB2, Stage IV breast cancer, ErbB1, breast cancer, lapatinib, Herceptin, trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW572016 oral tabletsDrug
Tablets contain 405mg of lapatinib ditosylate monohydrate, equivalent to 250mg lapatinib free base per tablet. Oval, orange, film-coated tablets.
| Study group | Role | What they receive |
|---|---|---|
| GW572016 in combination with trastuzumab | Experimental | Lapatinib:
A specified dose of lapatinib will be orally taken once daily, at least one hour before or one hour after the morning meal. Lapatinib should be taken at the same time of day wherever possible.
The starting dose of lapatinib should be 750 mg/day, which will be increased to 1000 mg/day (dose escalation group) according to the dose escalation criteria.
Trastuzumab:
Trastuzumab (4 mg/kg/day in the first week and 2 mg/kg/day for the 2nd and subsequent weeks) will be administered by intravenous infusion over at least 90 minutes immediately after administration of lapatinib. The fifth (Day 36) and subsequent doses may be administered up to 3 days after the scheduled date. In this case, however, the all following doses should be administered at one-week intervals. Receives: Drug: GW572016 oral tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal doses and toleration of the two drugs administered together Tumor progression measured by radiological imaging 4-8 weekly
To confirm the safety and tolerability of the recommended dose of lapatinib in combination with trastuzumab which was determined in a preceding overseas study, and to determine the recommended dose in Japan.
Measured: 6 Months
Secondary outcomes (1)
Clinical benefit Time to tumor response Length of response Time to progression of cancer 6 month progression free survival Overall survival as well as specific biomarkers in tumor tissue
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study start6 Apr 2006
- Primary completion10 Dec 2007
- Study completion10 Dec 2007
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
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
- NCT00371488
- Sponsor's protocol ID
- EGF105635
- Status last verified
- Aug 2018
- First submitted
- 31 Aug 2006
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Lapatinib in Combination With Trastuzumab
- ClinicalTrials.gov ID
- NCT00371488
- Acronym / sponsor ID
- EGF105635
- Conditions
- Neoplasms, Breast
- Keywords
- ErbB2, Stage IV breast cancer, ErbB1, breast cancer, lapatinib, Herceptin, trastuzumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2006 (actual)
- Primary completion
- 10 Dec 2007 (actual)
- Study completion
- 10 Dec 2007 (actual)
- First posted
- 4 Sep 2006 (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 two-part study (Phase I/Phase II). Part I is designed to find the optimal (best) doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and trastuzumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GW572016 in combination with trastuzumab | Experimental | Drug: GW572016 oral tabletsLapatinib: A specified dose of lapatinib will be orally taken once daily, at least one hour before or one hour after the morning meal. Lapatinib should be taken at the same time of day wherever possible. The starting dose of lapatinib should be 750 mg/day, which will be increased to 1000 mg/day (dose escalation group) according to the dose escalation criteria. Trastuzumab: Trastuzumab (4 mg/kg/day in the first week and 2 mg/kg/day for the 2nd and subsequent weeks) will be administered by intravenous infusion over at least 90 minutes immediately after administration of lapatinib. The fifth (Day 36) and subsequent doses may be administered up to 3 days after the scheduled date. In this case, however, the all following doses should be administered at one-week intervals. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with confirmed breast cancer who have received prior trastuzumab.
- Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
- Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.
Key exclusion criteria (1 listed)
- Patients with certain heart problems.
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 oral tabletsTablets contain 405mg of lapatinib ditosylate monohydrate, equivalent to 250mg lapatinib free base per tablet. Oval, orange, film-coated tablets. | Drug | GW572016 in combination with trastuzumab |
Primary outcome
Optimal doses and toleration of the two drugs administered together Tumor progression measured by radiological imaging 4-8 weekly
Time frame: 6 Months
To confirm the safety and tolerability of the recommended dose of lapatinib in combination with trastuzumab which was determined in a preceding overseas study, and to determine the recommended dose in Japan.
1 secondary outcome
Clinical benefit Time to tumor response Length of response Time to progression of cancer 6 month progression free survival Overall survival as well as specific biomarkers in tumor tissue
Time frame: 6 Months
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 31 Aug 2018.
- Results for study EGF105635 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GW572016 oral tablets in people with Neoplasms, Breast, run by GlaxoSmithKline at 2 sites in Japan.
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 1 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Optimal doses and toleration of the two drugs administered together Tumor progression measured by radiological imaging 4-8 weekly (time frame: 6 Months). 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 31 Aug 2018.