None listed
Conditions
Interventions
Drug : INVESTIGATIONAL PRODUCT, DOSE AND MODE OF ADMINISTRATION: All patients will
receive 5 tablets of 100 mg of ASLAN001 (ARRY-334543) i.e., 500 mg twice daily (1 g/day) orally for 57 days.
Sponsors
Pharmanet Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female patients 21 years of age or older at the time of written informed consent is obtained. 2) Patients with histologically confirmed adenocarcinoma of the stomach, gastrooesophageal junction or distal oesophagus with inoperable locally-advanced metastatic disease. 3) 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. 4) 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. 5) Patients with prior partial gastrectomy if they can take oral medications, can undergo gastroendoscopic biopsies and meet all other inclusion/exclusion criteria. 6) Patients with measurable or non-measurable disease per modified RECIST guidelines. All scans and x-rays used to document measurable or non-measurable disease must be done within 28 days prior to enrolment. 7) Patients with Eastern Cooperative Oncology Group (ECOG) (Appendix 2) performance status of 0 or 1 (within 14 days prior to enrolment). 8) Patients with adequate organ and haematological function as evidenced by the following laboratory studies within 14 days prior to enrolment: o Haematological function, as follows: -Absolute neutrophil count (ANC) = 1.5 x 109/L -Platelet count = 75 x 109/L -Haemoglobin = 9 g/dL o 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 o Renal functions, as follows: -Serum creatinine = 1.5 x ULN -Urea = 1.5 x ULN o Hepatic function, as follows: -Total bilirubin = 1.5 x ULN -Serum glutamic oxaloacetic transaminase (SGOT) (AST) and Serum glutamic pyruvic transaminase (SGPT) (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. 9) Able to provide written informed consent. 10) Able to communicate well with the Investigator, and understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1) Patients unable to swallow oral medications. 2) Patients with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy. 3) Patients with total gastrectomy. 4) Patients who underwent radiotherapy to the gastric remnant = 14 days prior to enrolment. Patients must have recovered from all radiotherapy-related toxicities. 5) 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. 6) Patients with ongoing or clinically significant active infection as judged by the Investigator. 7) Patients with known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen. 8) Pregnant (i.e., positive beta-human chorionic gonadotropin test) or breast-feeding women. 9) Patients who had inability to comply with protocol and/or were not available for follow-up assessments. 10) Patients who have received any investigational drug (or have used an investigational device) within the 30 days before receiving the first dose of study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The % of patients demonstrating clear evidence of inhibition of receptor auto-phosphorylation in HER-2 amplified patients on Day 29;The % of patients demonstrating clear evidence of inhibition of receptor auto-phosphorylation in HER-1 and HER-2 co-expressing patients on Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of patient showing inhibition of protein kinase B (AKT) phosphorylation on Day 29 and etc | — |
Countries
Korea, Republic of
Contacts
Public ContactSeock Ah Im
Seoul National University Hospital
Outcome results
None listed