NCT03130790

Varlitinib in Combination With mFOLFOX6 for Advanced or Metastatic Gastric Cancer (First Line)

Completed Phase 2, PHASE3 Last updated 15 February 2022

What this trial tests

Phase 2, PHASE3 trial testing Varlitinib in Gastric Cancer in 52 participants. Completed in 22 February 2019.

Timeline

31 August 2017

Primary endpoint
20 December 2018

22 February 2019

Quick facts

Lead sponsor	ASLAN Pharmaceuticals
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	52
Start date	31 August 2017
Primary completion	20 December 2018
Estimated completion	22 February 2019
Sites	16 locations across Hong Kong, Malaysia, Taiwan, Estonia, South Korea, Lithuania, Thailand, Singapore

Drugs / interventions tested

• Varlitinib — full drug profile →
• mFOLFOX6
• Placebo
• mFOLFOX6

Conditions studied

• Gastric Cancer — all drugs for Gastric Cancer →

Sponsor

ASLAN Pharmaceuticals — full company profile →

Who can join

21 and older, any sex, with Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This protocol for Varlitinib is developed for the treatment of Gastric Cancer. Varlitinib (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive inhibitor of the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal growth factor receptor (HER)2, and HER4. Varlitinib may be beneficial to subjects with cancer by simultaneous inhibition of these receptors. The purpose of this study is to determine the safety and efficacy of Varlitinib in combination with mFOLFOX6 for the treatment of Gastric Cancer. Treatment groups are Varlitinib+mFOLFOX6 and Placebo+mFOLFOX6.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Epidermal Growth Factor Receptor Family and its Role in Gastric Cancer.
   Arienti C, Pignatta S, Tesei A. · · 2019 · cited 97× · PMID 31850207 · DOI 10.3389/fonc.2019.01308
2. Tyrosine Kinase Receptors in Oncology.
   Esteban-Villarrubia J, Soto-Castillo JJ, Pozas J, San Román-Gil M, et al · · 2020 · cited 72× · PMID 33198314 · DOI 10.3390/ijms21228529
3. Targeted and novel therapy in advanced gastric cancer.
   Selim JH, Shaheen S, Sheu WC, Hsueh CT. · · 2019 · cited 66× · PMID 31632839 · DOI 10.1186/s40164-019-0149-6
4. Progress and challenges in HER2-positive gastroesophageal adenocarcinoma.
   Zhao D, Klempner SJ, Chao J. · · 2019 · cited 46× · PMID 31101074 · DOI 10.1186/s13045-019-0737-2
5. Recent Developments of Systemic Chemotherapy for Gastric Cancer.
   Arai H, Nakajima TE. · · 2020 · cited 37× · PMID 32354119 · DOI 10.3390/cancers12051100
6. Histological and mutational profile of diffuse gastric cancer: current knowledge and future challenges.
   Garcia-Pelaez J, Barbosa-Matos R, Gullo I, Carneiro F, et al · · 2021 · cited 33× · PMID 33724653 · DOI 10.1002/1878-0261.12948
7. Therapeutic Implications of Epidermal Growth Factor Receptor (EGFR) in the Treatment of Metastatic Gastric/GEJ Cancer.
   Adashek JJ, Arroyo-Martinez Y, Menta AK, Kurzrock R, et al · · 2020 · cited 19× · PMID 32850413 · DOI 10.3389/fonc.2020.01312
8. Multimodality Treatment in Metastatic Gastric Cancer: From Past to Next Future.
   Parisi A, Porzio G, Ficorella C. · · 2020 · cited 17× · PMID 32932914 · DOI 10.3390/cancers12092598