Clinical trial NCT01614522 (phase 2, status: completed)
Conditions: stomach neoplasms, cancer of stomach, cancer of the stomach, gastric cancer, gastric neoplasms
ICD codes: D13.1, C16.9, C16.1, C16.2, D37.1, C16.8, C16.5, D13.1, C16.9, C16.1, C16.2, D37.1, C16.8, C16.5, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: aslan001
SMILES: C[C@@H]1COC(NC2=CC=C3N=CN=C(NC4=CC=C(OCC5=NC=CS5)C(Cl)=C4)C3=C2)=N1
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.