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NCT02601378
A Phase I Study of LXS196 in Patients With Metastatic Uveal Melanoma.
Phase 1 trial testing LXS196 in Uveal Melanoma in 107 participants. Terminated before completion.
7 January 2022
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 107 |
| Start date | 1 February 2016 |
| Primary completion | 7 January 2022 |
| Estimated completion | 7 January 2022 |
| Sites | 6 locations across France, Netherlands, Norway, Australia, United States, Spain |
Drugs / interventions tested
- LXS196 — full drug profile →
- LXS196 and HDM201 — full drug profile →
Conditions studied
- Uveal Melanoma — all drugs for Uveal Melanoma →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Uveal Melanoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of LXS196 as a single agent and in combination with HDM201 in patients with metastatic uveal melanoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting transcription factors in cancer - from undruggable to reality.
Bushweller JH. · · 2019 · cited 741× · PMID 31511663 · DOI 10.1038/s41568-019-0196-7 -
Targeting p53 pathways: mechanisms, structures, and advances in therapy.
Wang H, Guo M, Wei H, Chen Y. · · 2023 · cited 580× · PMID 36859359 · DOI 10.1038/s41392-023-01347-1 -
Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z -
Treatment of uveal melanoma: where are we now?
Yang J, Manson DK, Marr BP, Carvajal RD. · · 2018 · cited 229× · PMID 29497459 · DOI 10.1177/1758834018757175 -
Combining Immune Checkpoint Inhibitors: Established and Emerging Targets and Strategies to Improve Outcomes in Melanoma.
Khair DO, Bax HJ, Mele S, Crescioli S, et al · · 2019 · cited 181× · PMID 30941125 · DOI 10.3389/fimmu.2019.00453 -
The force awakens: metastatic dormant cancer cells.
Park SY, Park SY, Nam JS. · · 2020 · cited 149× · PMID 32300189 · DOI 10.1038/s12276-020-0423-z -
Targeting p53-MDM2 interaction by small-molecule inhibitors: learning from MDM2 inhibitors in clinical trials.
Zhu H, Gao H, Ji Y, Zhou Q, et al · · 2022 · cited 141× · PMID 35831864 · DOI 10.1186/s13045-022-01314-3 -
Inhibition of p53 inhibitors: progress, challenges and perspectives.
Sanz G, Singh M, Peuget S, Selivanova G. · · 2019 · cited 106× · PMID 31310659 · DOI 10.1093/jmcb/mjz075
Verify or expand the search:
- PubMed search for NCT02601378
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Novartis Pharmaceuticals 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 NCT02601378 (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 Novartis Pharmaceuticals
- Last refreshed: 29 September 2022
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/NCT02601378.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing