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NCT03868423
Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers
Phase 2 trial testing Brigatinib in Advanced Malignant Neoplasm. Withdrawn.
20 November 2020
Quick facts
| Lead sponsor | Sameek Roychowdhury |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 20 March 2019 |
| Primary completion | 20 November 2020 |
| Estimated completion | 30 December 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Brigatinib (brigatinib) — full drug profile →
- Laboratory Biomarker Analysis — full drug profile →
- Quality-of-Life Assessment
- Questionnaire Administration
Conditions studied
- Advanced Malignant Neoplasm — all drugs for Advanced Malignant Neoplasm →
- ALK Fusion Protein Expression — all drugs for ALK Fusion Protein Expression →
- ALK Gene Amplification — all drugs for ALK Gene Amplification →
- ALK Gene Mutation — all drugs for ALK Gene Mutation →
Sponsor
Sameek Roychowdhury
Who can join
18 and older, any sex, with Advanced Malignant Neoplasm or ALK Fusion Protein Expression. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase II trial studies how well brigatinib works in treating patients with ALK and ROS1 gene alterations and solid cancers that have spread to nearby tissue and lymph nodes or other places in the body. Brigatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
New Insights Into the Role of Phenotypic Plasticity and EMT in Driving Cancer Progression.
Bhatia S, Wang P, Toh A, Thompson EW. · · 2020 · cited 63× · PMID 32391381 · DOI 10.3389/fmolb.2020.00071 -
Molecular pathways, resistance mechanisms and targeted interventions in non-small-cell lung cancer.
Wang Z, Xing Y, Li B, Li X, et al · · 2022 · cited 31× · PMID 36508072 · DOI 10.1186/s43556-022-00107-x -
ALK Inhibitors in Patients With ALK Fusion-Positive GI Cancers: An International Data Set and a Molecular Case Series.
Ambrosini M, Del Re M, Manca P, Hendifar A, et al · · 2022 · cited 24× · PMID 35476549 · DOI 10.1200/po.22.00015 -
Anaplastic Lymphoma Kinase (ALK) Inhibitors Show Activity in Colorectal Cancer With ALK Rearrangements: Case Series and Literature Review.
Hu T, Zhan J, Li L, He Y, et al · · 2025 · cited 4× · PMID 38381603 · DOI 10.1093/oncolo/oyae020 -
Response to anaplastic lymphoma kinase inhibitor in gastric cancer harboring <i>DCTN1-ALK</i> fusion: a case report and review.
Wang H, You L, Pan H, Qiu X, et al · · 2025 · PMID 41246301 · DOI 10.3389/fimmu.2025.1686666
Verify or expand the search:
- PubMed search for NCT03868423
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Brigatinib
Trials testing the same drug.
- NCT06813079 — Using Tumor Models to Determine Treatments · Phase 2 · not yet recruiting
- NCT06522360 — Brigatinib Plus Chemotherapy or Local Consolidation Therapy in ALK Positive Advanced Non-small Cell Lung Cancer (BrightS · Phase 2 · withdrawn
- NCT06532149 — ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer · recruiting
- NCT05718297 — Brigatinib Post Definitive Chemo-radiotherapy in Patients with ALK-fusion Non-small Cell Lung Cancer · Phase 2 · withdrawn
- NCT05721950 — A Study to Learn About Brigatinib Treatment Information Available in Chinese Participants With Non-Small-cell Lung Cance · active not recruiting
Other recruiting trials for Advanced Malignant Neoplasm
Currently open trials in the same condition.
- NCT06581419 — A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors · Phase 1, PHASE2 · recruiting
- NCT05985278 — Clinical Application of Lutetium [177Lu]-Catalase in Tumor Radionuclide Therapy · EARLY_PHASE1 · recruiting
- NCT04585750 — The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) · Phase 1, PHASE2 · recruiting
- NCT03203525 — Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurre · Phase 1 · active not recruiting
- NCT04119037 — Cordotomy in Reducing Pain in Patients With Advanced Cancer · NA · active not recruiting
Other Sameek Roychowdhury trials
Trials by the same sponsor.
- NCT06906562 — A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metasta · Phase 2 · recruiting
- NCT04233567 — Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations · Phase 2 · completed
- NCT02272998 — Ponatinib for Patients Whose Advanced Solid Tumor Cancer Has Activating Mutations Involving the Following Genes: FGFR1, · Phase 2 · completed
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 NCT03868423 (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 Sameek Roychowdhury
- Last refreshed: 18 February 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/NCT03868423.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing