Last updated: 11/04/2018 06:23:56
Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day)
Timeframe: daily throughout the study
Secondary outcomes:
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.
Timeframe: throughout the study
Interventions:
Drug: Lapatinib (GW572016) oral tablets
Enrollment:
24
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Adenocarcinoma
Product
lapatinib
Collaborators
Not applicable
Study date(s)
November 2005 to May 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
no
- Has a histologically confirmed adenocarcinoma of the esophagus.
- GE (gastroesophageal) junction or gastric cardia.
- Pregnant or lactating female.
- Prior resection of the small bowel.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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 location(s)
Location
GSK Investigational Site
Los Angeles, California, United States, 90095
Status
Study Complete
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14263
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-18-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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