Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Adenocarcinoma

Treatments: Drug: Lapatinib (GW572016) oral tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00259987

EGF102980

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)