Clinical trial: 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 (NCT01614522)

Eligibility 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? 1