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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
Phase 1, PHASE2 trial testing Variltinib, Paclitaxel in Gastric Cancer in 27 participants. Completed in 13 June 2022.
13 December 2021
Quick facts
| Lead sponsor | Yonsei University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 23 July 2019 |
| Primary completion | 13 December 2021 |
| Estimated completion | 13 June 2022 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Variltinib, Paclitaxel — full drug profile →
Conditions studied
- Gastric Cancer — all drugs for Gastric Cancer →
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):
-
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 -
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:
- PubMed search for NCT05400915
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Yonsei University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05400915 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yonsei University
- Last refreshed: 13 November 2023
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