Clinical trial · Interventional
Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lapatinib (GW572016) oral tablets | Drug | Lapatinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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 (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available