AdenocarcinomaPhase 2NCT00259987
Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus
A Phase 2 study testing Lapatinib (GW572016) oral tablets in people with Adenocarcinoma, run by GlaxoSmithKline at 6 sites in 3 countries.
Trial summary
This Phase II study will assess the efficacy, safety, and pharmacodynamics and pharmacokinetics of 1000 mg and 1500 mg lapatinib administered once daily in patients with relapsed adenocarcinoma of the esophagus, including tumors of the GE junction and gastric cardia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma
- What is being tested?
- Lapatinib (GW572016) oral tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 24 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Nov 2005to May 2007
- 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
- Has a histologically confirmed adenocarcinoma of the esophagus.
- GE (gastroesophageal) junction or gastric cardia.
- Must be of non-child-bearing potential or is of child-bearing potential.
- Have a negative serum pregnancy test and agree to an approved form of birth control.
- Have an ECOG (Eastern Cooperative Oncology Group) Performance status less than or equal to 2.
- Have a life expectancy of at least 12 weeks.
- Have provided written informed consent.
- Investigator considers patient to be fit for study from lab test results and interview.
Who cannot join
- Pregnant or lactating female.
- Prior resection of the small bowel.
- Received major surgery.
- Received prior radiation therapy to the mediastinum or abdomen.
- Has a known immediate or delayed hypersensitivity reaction.
- Idiosyncrasy to drugs chemically related to the study drug.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States3 sites
GSK Investigational Site
Ann Arbor, Michigan, 48109
GSK Investigational Site
Buffalo, New York, 14263
GSK Investigational Site
Los Angeles, California, 90095
Peru2 sites
GSK Investigational Site
Lima, 34
GSK Investigational Site
San Isidro, Lima region, Lima 27
About this study
Official title: A Phase II, Open-Label Study Evaluating Clinical Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Effects of Lapatinib (GW572016) in Patients With Relapsed Adenocarcinoma of the Esophagus, Including Tumors of the Gastroesophageal Junction and Gastric Cardia
This Phase II study will assess the efficacy, safety, and pharmacodynamics and pharmacokinetics of 1000 mg and 1500 mg lapatinib administered once daily in patients with relapsed adenocarcinoma of the esophagus, including tumors of the GE junction and gastric cardia.
- Conditions
- Adenocarcinoma
- Being tested
- Lapatinib (GW572016) oral tablets
- Keywords
- relapsed adenocarcinoma, esophagus, tumors, GE junction, cancer, lapatinib, gastric cardia
- Medical subject headings
- Adenocarcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lapatinib (GW572016) oral tabletsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day)
Measured: daily throughout the study
Secondary outcomes (1)
Safety and clinical benefit of lapatinib therapy, progression-free survival, and response duration in the two dose levels combined as well as for the two doses separately.
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startNov 2005
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259987
- Sponsor's protocol ID
- EGF102980
- Status last verified
- May 2009
- First submitted
- 30 Nov 2005
- Last updated
- 18 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label Study Evaluating Clinical Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Effects of Lapatinib (GW572016) in Patients With Relapsed Adenocarcinoma of the Esophagus, Including Tumors of the Gastroesophageal Junction and Gastric Cardia
- ClinicalTrials.gov ID
- NCT00259987
- Acronym / sponsor ID
- EGF102980
- Conditions
- Adenocarcinoma
- Keywords
- relapsed adenocarcinoma, esophagus, tumors, GE junction, cancer, lapatinib, gastric cardia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- May 2007 (actual)
- First posted
- 1 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.
This Phase II study will assess the efficacy, safety, and pharmacodynamics and pharmacokinetics of 1000 mg and 1500 mg lapatinib administered once daily in patients with relapsed adenocarcinoma of the esophagus, including tumors of the GE junction and gastric cardia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has a histologically confirmed adenocarcinoma of the esophagus.
- GE (gastroesophageal) junction or gastric cardia.
- Must be of non-child-bearing potential or is of child-bearing potential.
- Have a negative serum pregnancy test and agree to an approved form of birth control.
- Have an ECOG (Eastern Cooperative Oncology Group) Performance status less than or equal to 2.
Key exclusion criteria (6 listed)
- Pregnant or lactating female.
- Prior resection of the small bowel.
- Received major surgery.
- Received prior radiation therapy to the mediastinum or abdomen.
- Has a known immediate or delayed hypersensitivity reaction.
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 |
|---|---|---|
| Lapatinib (GW572016) oral tablets | Drug | – |
Primary outcome
Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day)
Time frame: daily throughout the study
1 secondary outcome
Safety and clinical benefit of lapatinib therapy, progression-free survival, and response duration in the two dose levels combined as well as for the two doses separately.
Time frame: throughout the study
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 18 May 2009.
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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, MD study director
GlaxoSmithKline
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lapatinib (GW572016) oral tablets in people with Adenocarcinoma, run by GlaxoSmithKline at 6 sites in 3 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 8 inclusion and 6 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 18 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Peru, Netherlands. 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?
Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day) (time frame: daily throughout the study). 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 18 May 2009.