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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

Completed Phase 1, PHASE2 Last updated 13 November 2023
What this trial tests

Phase 1, PHASE2 trial testing Variltinib, Paclitaxel in Gastric Cancer in 27 participants. Completed in 13 June 2022.

Timeline
23 July 2019
Primary endpoint
13 December 2021
13 June 2022

Quick facts

Lead sponsorYonsei University
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment27
Start date23 July 2019
Primary completion13 December 2021
Estimated completion13 June 2022
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Yonsei University

Who can join

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

Sponsor's own description

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.

Publications & conference data

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

  1. Substances of Natural Origin in Medicine: Plants vs. Cancer.
    Gielecińska A, Kciuk M, Mujwar S, Celik I, et al · · 2023 · cited 39× · PMID 37048059 · DOI 10.3390/cells12070986
  2. Varlitinib and Paclitaxel for EGFR/HER2 Co-expressing Advanced Gastric Cancer: A Multicenter Phase Ib/II Study (K-MASTER-13).
    Koo DH, Jung M, Kim YH, Jeung HC, et al · · 2024 · cited 2× · PMID 38697849 · DOI 10.4143/crt.2023.1324

Verify or expand the search:

Other recruiting trials for Gastric Cancer

Currently open trials in the same condition.

Other Yonsei University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05400915.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing