A Clinical Trial Evaluating the Effect of ASLAN001 in Patients With Recurrent/Metastatic Gastric Cancer Whose Tumors Are Either HER-2 Amplified or Co-expressing HER-1 and HER-2

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether ASLAN001 has an effect in patients with recurrent or metastatic adenocarcinoma of the stomach, gastrooesophageal junction, or lower third of the oesophagus whose tumours over-express HER-1 and HER-2, or whose tumours are HER-2 gene-amplified.

Maximum of 26 patients will participate in South Korea and the patients will be assigned to either group A or group B according to the results of tests done on tumor tissue obtained by biopsy to determine HER-1 and HER-2 status.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aslan Pharmaceuticals

Criteria

Inclusion Criteria:

• Male or female patients 21 years of age or older at the time written informed consent is obtained.

• Patients with histologically confirmed adenocarcinoma of the stomach, gastro-oesophageal junction or distal oesophagus with inoperable locally-advanced metastatic disease.

• Patients with tumours with immunohistochemical evidence of expression of HER-1 (at level of + or ++ or +++) and HER-2 (at level of + or ++ or +++) using standard criteria OR tumours with gene-amplification of HER-2 by standard FISH.

• Patient has received 1 or more prior chemotherapy for the treatment of adenocarcinoma of the stomach, gastro-oesophageal junction or distal oesophagus with metastatic disease.

• Patients with prior partial gastrectomy if they can take oral medications, and can undergo gastroendoscopic biopsies and meet all other inclusion/exclusion criteria.

• Patients with measurable and non-measurable disease per modified RECIST guidelines. All scans and x-rays used to document measurable or non-measurable disease must be done within a 28-day period prior to enrollment.

• Patient with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (within 14 days prior to enrolment).

• Patient with adequate organ and haematological function as evidenced by the following laboratory studies within 14 days prior to enrollment:

• Haematological function, as follows:

• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

• Platelet count ≥ 75 x 109/L

• Haemoglobin ≥ 9 g/dL

• Coagulation functions, as follows:

• Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 x upper limits of normal (ULN) per institutional laboratory normal range

• International normalized ratio (INR) ≤ 1.5

• Renal functions, as follows:

• Serum creatinine ≤ 1.5 x ULN

• Urea ≤ 1.5 x ULN

• Hepatic function, as follows:

• Total bilirubin ≤ 1.5 x ULN

• Serum glutamic oxaloacetic transaminase (SGOT)/aspartate transaminase (AST) and serum glutamic pyruvic transaminase (SGPT)/ alanine transaminase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases are present)*.

• Except where due to direct disease involvement of the liver at the discretion of the investigator.

Exclusion Criteria:

• Patients unable to swallow oral medications

• Patients with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy.

• Patients who underwent radiotherapy to the gastric remnant ≤ 14 days prior to enrolment. Patients must have recovered from all radiotherapy-related toxicities.

• Patients with total gastrectomy.

• Patients who have uncontrolled, clinically significant symptomatic cardiovascular diseases within 6 months prior to enrolment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure or arrhythmias not controlled by outpatient medication.

• Patients with ongoing or clinically significant active infection as judged by the Investigator.

• Pregnant (i.e., positive beta-human chorionic gonadotropin test) or is breast-feeding women.