NCT01697605 is a Phase 1 clinical trial of BGJ398 in Tumor With Alterations of the FGF-R, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT01697605?

NCT01697605 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT01697605?

Interventions in NCT01697605: BGJ398.

What condition does NCT01697605 study?

NCT01697605 studies Tumor With Alterations of the FGF-R.

Is NCT01697605 still recruiting?

NCT01697605 is currently completed. Last updated 8 December 2020.

Last reviewed 2020-12-08 · How we verify

NCT01697605

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase I Study of Oral BGJ398 in Asian Patients

Completed Phase 1 Last updated 8 December 2020

What this trial tests

Phase 1 trial testing BGJ398 in Tumor With Alterations of the FGF-R in 9 participants. Completed in 7 February 2019.

Timeline

19 October 2012

Primary endpoint
7 February 2019

7 February 2019

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	19 October 2012
Primary completion	7 February 2019
Estimated completion	7 February 2019
Sites	8 locations across China, Japan

Drugs / interventions tested

BGJ398 — full drug profile →

Conditions studied

Tumor With Alterations of the FGF-R — all drugs for Tumor With Alterations of the FGF-R →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Tumor With Alterations of the FGF-R. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).

Publications & conference data

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

FGF19-<i>FGFR4</i> Signaling in Hepatocellular Carcinoma.
Raja A, Park I, Haq F, Ahn SM. · · 2019 · cited 111× · PMID 31167419 · DOI 10.3390/cells8060536
FGFR3-TACC3 fusion in solid tumors: mini review.
Costa R, Carneiro BA, Taxter T, Tavora FA, et al · · 2016 · cited 107× · PMID 27409839 · DOI 10.18632/oncotarget.10482
Structure, activation and dysregulation of fibroblast growth factor receptor kinases: perspectives for clinical targeting.
Farrell B, Breeze AL. · · 2018 · cited 77× · PMID 30545934 · DOI 10.1042/bst20180004
Crosstalk Between Cancer Associated Fibroblasts and Cancer Cells in Scirrhous Type Gastric Cancer.
Miki Y, Yashiro M, Moyano-Galceran L, Sugimoto A, et al · · 2020 · cited 37× · PMID 33178597 · DOI 10.3389/fonc.2020.568557
Fibroblast growth factor signaling and inhibition in non-small cell lung cancer and their role in squamous cell tumors.
Salgia R. · · 2014 · cited 20× · PMID 24711160 · DOI 10.1002/cam4.238
Clinical trials of tyrosine kinase inhibitors for lung cancer in China: a review.
Su S, Wu YL. · · 2017 · cited 19× · PMID 28784178 · DOI 10.1186/s13045-017-0514-z
C1632 suppresses the migration and proliferation of non-small-cell lung cancer cells involving LIN28 and FGFR1 pathway.
Chen JY, Chen YJ, Liu L, Jin XX, et al · · 2022 · cited 12× · PMID 34913237 · DOI 10.1111/jcmm.17094

Verify or expand the search:

Other trials of BGJ398

Trials testing the same drug.

NCT03773302 — Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations · Phase 3 · terminated
NCT03510455 — BGJ398 for the Treatment of Tumor-Induced Osteomalacia · Phase 2 · terminated
NCT02706691 — BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer · Phase 2 · terminated
NCT02657486 — BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder · NA · completed
NCT02257541 — BGJ398 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST) · Phase 1, PHASE2 · completed

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01697605 (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: 8 December 2020

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/NCT01697605.

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