NCT05400915

Two-Part, Phase Ib/II, Open Label, Single-Arm, Multi-center Study to Evaluate the Safety and Efficacy of Varlitinib in Combination With Weekly Paclitaxel in EGFR/HER2 Co-expressing Advanced or Metastatic Gastric Cancer Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Phase Ib part of this study determines the recommended phase II dose schedule based on ASLAN001-004 phase Ib (dose-confirmation study of Varlitinib combined with weekly paclitaxel and carboplatin or trastuzumab (Herceptin) in advanced solid tumours). Phase II part of this study further assesses the safety and clinical efficacy of this combination treatment as a second line treatment in EGFR/HER2 co-expressing advanced or metastatic gastric cancer.

Detailed description

This is a two-part, Phase Ib/II, Open label, single arm, multicenter study to determine the maximum tolerated dose (MTD) and the recommended dose schedule of varlitinib in combination with paclitaxel and to further ASLAN001-017\_Clinical Study Protocol Version 01\_09 Oct 2018 CONFIDENTIAL 7 assess the safety and clinical efficacy of this combined treatment in EGFR/HER2 co-expressing advanced or metastatic gastric cancer after first line treatment. The objective of this trial is to allow development of an effective chemotherapeutic regimen in patients with advanced/metastatic gastric cancer with EGFR/HER-2 co-expression. This trial will also be included in second line Umbrella trial in Yonsei Cancer Center (YCC) (Figure 1). Patients with EGFR and HER2 co-expression will be confirmed by immunohistochemistry (IHC) and NGS in a central laboratory (Yonsei Cancer Center), and those who meet all eligibility criteria will be enrolled in this study. The patients enrolled in the study will receive combined treatment with varlitinib and paclitaxel until progressive disease is confirmed or at least 1 discontinuation criterion is met (i.e development of intolerable toxicities, patient"s refusal or consent withdrawal or death). Based on previously reported study results, we arrived at an assumption that about 20-25% of screened patients will be categorized as EGFR and HER2 co-expressing gastric cancer.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Variltinib, Paclitaxel	Varlitinib will be administered orally to the study participants at doses 300mg, BID in combination with the weekly intravenous infusion of Paclitaxel for 3 weeks with a rest period of 1 week.

Timeline

• Start date: 2019-07-23
• Primary completion: 2021-12-13
• Completion: 2022-06-13
• First posted: 2022-06-02
• Last updated: 2023-11-13

Locations

1 site across 1 country: South Korea