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NCT03499626
Phase 1b of ASLAN001 (Varlitinib) in Patients With Advanced/ Metastatic Hepatocellular Carcinoma (HCC)
Phase 1, PHASE2 trial testing ASLAN001 in Advanced/ Metastatic Hepatocellular Carcinoma in 22 participants. Status unknown.
5 May 2019
Quick facts
| Lead sponsor | National University Hospital, Singapore |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 5 May 2017 |
| Primary completion | 5 May 2019 |
| Estimated completion | 5 May 2021 |
| Sites | 1 location across Singapore |
Drugs / interventions tested
- ASLAN001 — full drug profile →
Conditions studied
- Advanced/ Metastatic Hepatocellular Carcinoma — all drugs for Advanced/ Metastatic Hepatocellular Carcinoma →
Sponsor
National University Hospital, Singapore
Who can join
Adults 21 to 99, any sex, with Advanced/ Metastatic Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-arm, allocation open label study. Phase 1 is a dose-finding phase in patients with advanced/ metastatic hepatocellular carcinoma (HCC) who have progressed on first line Sorafenib or Lenvatinib. The primary objective of this study will be to establish the maximal tolerable dose (MTD) of ASLAN001 (Varlitinib) in the study population The secondary objectives include: 1. To evaluate the efficacy of ASLAN001 (Varlitinib), as measured by duration of response (DoR), progression free survival (PFS), overall survival (OS) and disease control rate (DCR) 2. To assess the ORR, DoR, PFS, DCR and OS by tumor EGFR/HER2/HER3/HER4 status 3. To identify tumor and host biomarkers predictive of treatment response or toxicity to ASLAN001.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
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 -
Cell Surface Proteins in Hepatocellular Carcinoma: From Bench to Bedside.
Siracusano G, Tagliamonte M, Buonaguro L, Lopalco L. · · 2020 · cited 8× · PMID 31991677 · DOI 10.3390/vaccines8010041 -
Resistance to Antiangiogenic Therapy in Hepatocellular Carcinoma: From Molecular Mechanisms to Clinical Impact.
Federico P, Giunta EF, Tufo A, Tovoli F, et al · · 2022 · cited 5× · PMID 36551730 · DOI 10.3390/cancers14246245 -
Predictive value of biomarkers for lenvatinib in hepatocellular carcinoma.
Hao X, Li Z, Su X, Li J, et al · · 2025 · PMID 40851753 · DOI 10.1177/17588359251363102
Verify or expand the search:
- PubMed search for NCT03499626
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ASLAN001
Trials testing the same drug.
- NCT07166367 — Phase II Study to Assess the Efficacy of ASLAN001 Plus Capecitabine in CNS Metastases for HER2+ Breast Cancer · Phase 2 · terminated
- NCT02338245 — Study of ASLAN001 in Combination With Capecitabine in MBC That Has Failed on Prior Trastuzumab · Phase 2 · completed
- NCT02648425 — Safety and Tolerability of ASLAN001 in Combination With Cisplatin and 5-FU or Cisplatin and Capecitabine · Phase 1 · completed
Other National University Hospital, Singapore trials
Trials by the same sponsor.
- NCT06027983 — Chimeric Receptor T Cells With Trastuzumab in HER2+ Advanced Breast Cancer and Other Solid Tumors · Phase 1, PHASE2 · not yet recruiting
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- NCT07319676 — Antigen Targeted T Cell Therapy for Relapsed/Refractory B Cell Lymphomas · Phase 1, PHASE2 · recruiting
- NCT06983769 — CPAP vs MAD for OSA in Patients With Cognitive Impairment. A Randomized Clinical Trial · NA · recruiting
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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 NCT03499626 (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 National University Hospital, Singapore
- Last refreshed: 17 April 2018
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/NCT03499626.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing