NCT01614522

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

May 22, 2012

Last Update Submit

January 13, 2015

Conditions

Stomach NeoplasmsCancer of StomachCancer of the StomachGastric CancerGastric Neoplasms

Keywords

Metastatic gastro-oesophageal carcinomaRecurrent gastro-oesophageal carcinomaGastric cancerHER-1HER-2

Outcome Measures

Primary Outcomes (2)

  • The percentage of patients demonstrating clear evidence of inhibition of receptor auto-phosphorylation in HER-2 amplified patients on Day 29.

    Day 29

  • The percentage of patients demonstrating clear evidence of inhibition of receptor auto-phosphorylation in HER-1 and HER-2 co-expressing patients on Day 29.

    Day 29

Secondary Outcomes (5)

  • The percentage of patients showing inhibition of AKT phosphorylation on Day 29.

    Day 29

  • The percentage of patients showing inhibition of MAPK phosphorylation on Day 29.

    Day 29

  • The percentage of patients showing inhibition of Ki67 on Day 29.

    Day 29

  • The percentage of patients showing induction of apoptosis as measured by TUNEL on Day 29.

    Day 29

  • Objective Response Rate

    Day 57

Study Arms (2)

HER-2 Amplified

EXPERIMENTAL
Drug: ASLAN001

HER-1 & HER-2 Co-expression

EXPERIMENTAL
Drug: ASLAN001

Interventions

ASLAN001DRUG

ASLAN001 500mg BID

HER-1 & HER-2 Co-expressionHER-2 Amplified

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Hospital

Bundang, Seoul, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Seock-Ah Im, Dr.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2012

First Posted

June 8, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

KR(2)