Gastric Cancer Clinical Trial
Official title:
Phase II Open Label Study to Evaluate the Biological Activity of ASLAN001 (ARRY 334543) in Patients With Recurrent/Metastatic Gastric, Gastro-oesophageal Junction, and Oesophageal Carcinoma Whose Tumours Are Epidermal Growth Factor Receptor-2 (HER 2) Amplified or Co-expressing Epidermal Growth Factor Receptor-1 (HER-1) and HER-2.
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.
About 1 million new cases of gastric cancer were estimated to have occurred in 2008 (988,000
cases, 7.8% of the total), making it currently the fourth most common malignancy in the
world, behind cancers of the lung, breast, and colo-rectum. Gastric cancer is also the
second leading cause of cancer-related death in both sexes worldwide with 700,000 deaths
occurring annually. The incidence and mortality rates for gastric cancer vary widely in
different regions of the world. The incidence has dramatically declined in the United States
where it ranks seventh as a cause of cancer- related deaths. In the Asia-Pacific region, the
highest incidences of gastric cancer can be found in China, Japan, and Korea, where the age
standardized incidence rate (ASR) is greater than 20 per 100,000 populations. Intermediate
risk countries (ASR 11-19/100,000 population) include Malaysia, Singapore, and Taiwan, while
low-risk countries (ASR < 10/100,000 population) include Australia, New Zealand, India, and
Thailand.
Approximately 95% of all malignant gastric neoplasms are adenocarcinomas. One of the most
striking epidemiologic observations has been the increasing incidence of adenocarcinomas
involving the proximal stomach and distal oesophagus including the oesophagogastric
junction. These tumours are thought to have different etiologic factors; gastric body and
antral lesions are associated with low acid production and Helicobacter pylori infection,
whereas cardiac lesions are not associated with either.
The treatment for advanced and un-resectable disease has remained essentially unchanged for
the past 2 decades, with platinum and fluoro-pyridine-based combination chemotherapy being
the mainstay of therapy. The molecular biology responsible for carcinogenesis, tumour
biology, and response to therapy in gastric cancer are active areas of investigation.
Amplification and/or over-expression of epidermal growth factor receptor-2 (HER 2) have been
found to promote tumourigenesis and to be involved in the pathogenesis of gastric cancer.
Recently, data from randomised studies of trastuzumab (Herceptin®) in patients with HER 2
amplification demonstrated significant improvement in outcome in comparison to chemotherapy
alone. Studies on a number other molecularly targeted agents used alone or in combination
with chemotherapy have been undertaken, or are ongoing. Translational research, undertaken
as part of these studies, demonstrates the great molecular heterogeneity of the disease,
with multiple growth factor and survival pathways being implicated.
In view of this, successful therapeutic intervention is likely to require both the
identification of molecularly defined subsets of disease, and the evaluation of
rationally-selected combinations of targeted agents.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05551416 -
The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
|
||
Completed |
NCT05518929 -
Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients
|
Phase 4 | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03219593 -
Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Recruiting |
NCT05536102 -
The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy)
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05415098 -
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
Active, not recruiting |
NCT04082364 -
Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
|
Phase 2/Phase 3 | |
Withdrawn |
NCT03766607 -
Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT04118114 -
Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT01924533 -
Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
|
Phase 3 | |
Terminated |
NCT01641939 -
A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer
|
Phase 2/Phase 3 | |
Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
Active, not recruiting |
NCT04908813 -
Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04249739 -
Pembrolizumab + Capecitabine/Oxaliplatin (CapeOx) -HER2 Nagative and Pembrolizumab + Trastuzumab + Cisplatin/Capecitabine HER2 Positive
|
Phase 2 | |
Recruiting |
NCT05514158 -
To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG)
|
Phase 1 | |
Recruiting |
NCT04931654 -
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 |