 |
1 Disease |  |
4 Trials |
|
4 Trials |  |
159 News |  |
| «12 |
- | derazantinib (ARQ 087) / Basilea
Journal: Antitumor Activity of a Novel Fibroblast Growth Factor Receptor (FGFR) Inhibitor for Intrahepatic Cholangiocarcinoma. (Pubmed Central) - Mar 29, 2020
We examined FGFR expression in CCA tumor specimens obtained from patients and CCA cell lines, and then determined the effects of the novel FGFR inhibitor, derazantinib (DZB; formally, ARQ 087), which is currently in clinical phase 2 trials for intrahepatic CCA...These correlated in vitro studies suggest that FGFR may play an important role in the pathogenesis and biology of CCA. Our findings support the notion that FGFR inhibitors, like DZB, should be further evaluated at the clinical stage as targeted therapy for CCA treatment.
- derazantinib (ARQ 087) / Basilea, Tecentriq (atezolizumab) / Roche
FIDES-02, a phase Ib/II study of derazantinib (DZB) as monotherapy and combination therapy with atezolizumab (A) in patients with surgically unresectable or metastaticurothelial cancer (UC) and FGFR genetic aberrations. (Poster Board N8) - Dec 22, 2019 - Abstract #ASCOGU2020ASCO_GU_1327;
P1b/2
Preclinical data show that DZB reduced CSF1-stimulated CSF1R phosphorylation in macrophages, with a maximal effect similar to the CSF1R inhibitor BLZ945, suggesting DZB could have an effect on tumor-associated macrophage regulation...Cohort 1 (C1) enrolls pts after one or more standard chemotherapy ± ICB regimens (Phase 2; treatment: DZB); C2 enrolls patients with any advanced solid tumor, any FGFR status, any prior treatment (Phase 1b; for RP2D of DZB+A); C3 enrolls first-line patients with cisplatin-ineligible, PD-L1-low UC (Phase 2; DZB v DZB+A); C4 enrolls UC patients resistant to FGFR inhibitor treatment (Phase 2; DZB v DZB+A)...Clinical trial information: NCT04045613. Research Funding: Basilea Pharmaceutica International Ltd.
- derazantinib (ARQ 087) / Basilea, Tecentriq (atezolizumab) / Roche
FIDES-02, a phase Ib/II study of derazantinib (DZB) as monotherapy and combination therapy with atezolizumab (A) in patients with surgically unresectable or metastaticurothelial cancer (UC) and FGFR genetic aberrations. (Poster Board N8) - Dec 22, 2019 - Abstract #ASCOGU2020ASCO_GU_1045;
P1b/2
Preclinical data show that DZB reduced CSF1-stimulated CSF1R phosphorylation in macrophages, with a maximal effect similar to the CSF1R inhibitor BLZ945, suggesting DZB could have an effect on tumor-associated macrophage regulation...Cohort 1 (C1) enrolls pts after one or more standard chemotherapy ± ICB regimens (Phase 2; treatment: DZB); C2 enrolls patients with any advanced solid tumor, any FGFR status, any prior treatment (Phase 1b; for RP2D of DZB+A); C3 enrolls first-line patients with cisplatin-ineligible, PD-L1-low UC (Phase 2; DZB v DZB+A); C4 enrolls UC patients resistant to FGFR inhibitor treatment (Phase 2; DZB v DZB+A)...Clinical trial information: NCT04045613. Research Funding: Basilea Pharmaceutica International Ltd.
- derazantinib (ARQ 087) / Basilea
FIDES-01, a phase II study of derazantinib in patients with unresectable intrahepatic cholangiocarcinoma (iCCA) and FGFR2 fusions and mutations or amplifications (M/A). (Level 1, West Hall - Poster Board P10) - Dec 10, 2019 - Abstract #ASCOGI2020ASCO-GI_739;
P1/2, P2
Research Funding: Basilea Pharmaceutica International Ltd. Pharmaceutical/Biotech Company
- derazantinib (ARQ 087) / Basilea
The FGFR-inhibitor derazantinib (DZB) is active in PDX-models of GI-cancer with specific aberrations in FGFR. (Level 1, West Hall - Poster Board G10) - Dec 10, 2019 - Abstract #ASCOGI2020ASCO-GI_360;
A clinical trial is planned in patients with gastric cancer to investigate DZB as mono- and combination-therapy. Research Funding: Basilea Pharmaceutica International Ltd
- || derazantinib (ARQ 087) / Merck (MSD)
Trial completion: Mass Balance and Pharmacokinetics Study of Derazantinib in Healthy Male Subjects (clinicaltrials.gov) - Nov 24, 2019
P1, N=12, Completed, Sponsor: Basilea Pharmaceutica
Research Funding: Basilea Pharmaceutica International Ltd Recruiting --> Completed
- derazantinib (ARQ 087) / Basilea
Derazantinib (DZB): A dual FGFR/CSF1R-inhibitor active in PDX-models of urothelial cancer (Board 159: Level 2 - Hall D) - Oct 25, 2019 - Abstract #AACRNCIEORTC2019AACR_NCI_EORTC_701;
P1b/2
Screens in UC models indicate that DZB efficacy is driven by FGFR mutation and expression and, potentially, CSF1R modulation. A clinical trial is ongoing in UC patients (NCT04045613) to assess DZB monotherapy, and combination with the PD-L1 antibody atezolizumab.
- derazantinib (ARQ 087) / Basilea
ANTITUMOR ACTIVITY OF A NOVEL FGFR INHIBITOR IN INTRAHEPATIC CHOLANGIOCARCINOMA (Hynes Convention Center, Hall B) - Sep 29, 2019 - Abstract #AASLD2019AASLD_2904;
Based on these correlative in vitro studies, we conclude that FGFR may play an important role in the pathogenesis and biology of CCA. Our findings support that FGFR inhibitors, like DZB, deserve to be evaluated further at the clinical level as targeted therapy for CCA treatment
- | derazantinib (ARQ 087) / Merck (MSD)
New P1 trial: Mass Balance and Pharmacokinetics Study of Derazantinib in Healthy Male Subjects (clinicaltrials.gov) - Sep 22, 2019
P1, N=12, Recruiting, Sponsor: Basilea Pharmaceutica
- | derazantinib (ARQ 087) / Basilea
Journal: Derazantinib (ARQ 087) in advanced or inoperable FGFR2 gene fusion-positive intrahepatic cholangiocarcinoma. (Pubmed Central) - Sep 22, 2019
P1/2, P2
Derazantinib demonstrated encouraging anti-tumour activity and a manageable safety profile in patients with advanced, unresectable iCCA with FGFR2 fusion who progressed after chemotherapy. A pivotal trial of derazantinib in iCCA is ongoing (NCT03230318).
- | derazantinib (ARQ 087) / Merck (MSD)
New trial, Metastases: Expanded Access Use of Derazantinib for Advanced Intrahepatic Cholangiocarcinoma (iCCA) With FGFR Genomic Alterations (clinicaltrials.gov) - Sep 11, 2019
P, N=0, Available, Sponsor: Basilea Pharmaceutica
- derazantinib (ARQ 087) / Basilea
Efficacy of derazantinib (DZB) in patients (pts) with intrahepatic cholangiocarcinoma (iCCA) expressing FGFR2-fusion or FGFR2 mutations/amplifications (Poster Area (Hall 4)) - Sep 11, 2019 - Abstract #ESMO2019ESMO_2366;
P1/2
While the influence of prognostic variables still has to be confirmed, the anti-tumor efficacy of DZB seen in pts with FGFR2 GA other than fusions warrant further clinical investigation. Legal entity responsible for the study: Basilea Pharmaceutica International Ltd.
- | infigratinib (BGJ398) / BridgeBio, Pfizer, derazantinib (ARQ 087) / Basilea
Review, Journal: FGFR2 genomic aberrations: Achilles heel in the management of advanced cholangiocarcinoma. (Pubmed Central) - Sep 5, 2019
Genomic studies have shown that FGFR2 aberrations are implicated in approximately 15% of intrahepatic cholangiocarcinomas, which make FGFR2 aberrations (Achilles heel) as potential novel targets in the management of cholangiocarcinoma. The current review comprehensively focuses on the role of FGFR2 inhibition either alone or in combination with other targeted therapy that act on down-stream and alternate kinase pathways in cholangiocarcinoma.
- | derazantinib (ARQ 087) / Merck (MSD)
Enrollment change, Metastases: FIDES-01: Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - Jul 29, 2019
P2, N=143, Recruiting, Sponsor: Basilea Pharmaceutica
The current review comprehensively focuses on the role of FGFR2 inhibition either alone or in combination with other targeted therapy that act on down-stream and alternate kinase pathways in cholangiocarcinoma. N=100 --> 143
- ||| derazantinib (ARQ 087) / Merck (MSD)
Trial completion, Metastases: Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations (clinicaltrials.gov) - Apr 20, 2019
P1/2, N=119, Completed, Sponsor: Basilea Pharmaceutica
N=100 --> 143 Active, not recruiting --> Completed
- ||| derazantinib (ARQ 087) / Basilea
Clinical: $BSLN Derazantinib ICCA ph2 final readout in 2020 (patients w/ FGFR2 gene fusion) (Twitter) - Apr 15, 2019
- | derazantinib (ARQ 087) / Merck (MSD)
Phase classification, Metastases: FIDES-01: Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - Feb 23, 2018
P2, N=100, Recruiting, Sponsor: ArQule
Active, not recruiting --> Completed Phase classification: P3 --> P2
- || derazantinib (ARQ 087) / Merck (MSD)
Trial primary completion date, Metastases: Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations (clinicaltrials.gov) - Jan 12, 2018
P1/2, N=109, Active, not recruiting, Sponsor: ArQule
Phase classification: P3 --> P2 Trial primary completion date: Dec 2017 --> Jun 2018
- |||||||||| derazantinib (ARQ 087) / Merck (MSD)
New P3 trial, Metastases: FIDES-01: Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - Jul 25, 2017
P3, N=100, Recruiting, Sponsor: ArQule
- || derazantinib (ARQ 087) / Merck (MSD)
P1/2 data, Trial primary completion date, Metastases: Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations (clinicaltrials.gov) - Jul 13, 2017
P1/2, N=109, Active, not recruiting, Sponsor: ArQule
Trial primary completion date: Dec 2017 --> Jun 2018 Trial primary completion date: Jun 2017 --> Dec 2017
- ||| derazantinib (ARQ 087) / Merck (MSD)
Enrollment closed, P1/2 data, Trial primary completion date, Metastases: Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations (clinicaltrials.gov) - Dec 27, 2016
P1/2, N=109, Active, not recruiting, Sponsor: ArQule
Trial primary completion date: Jun 2017 --> Dec 2017 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2016 --> Jun 2017
- || derazantinib (ARQ 087) / Merck (MSD)
P1/2 data, Trial primary completion date, Metastases: Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations (clinicaltrials.gov) - May 17, 2016
P1/2, N=120, Recruiting, Sponsor: ArQule
Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2016 --> Jun 2017 Trial primary completion date: Jun 2016 --> Dec 2016
- || derazantinib (ARQ 087) / Merck (MSD)
P1/2 data, Phase classification, Trial primary completion date, Metastases: Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations (clinicaltrials.gov) - Oct 23, 2015
P1/2, N=120, Recruiting, Sponsor: ArQule
Trial primary completion date: Jun 2016 --> Dec 2016 Phase classification: P1 --> P1/2 | Trial primary completion date: Nov 2015 --> Jun 2016
- || derazantinib (ARQ 087) / Merck (MSD)
P1/2 data, Enrollment change, Metastases: Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations (clinicaltrials.gov) - Nov 12, 2014
P1, N=120, Recruiting, Sponsor: ArQule
Phase classification: P1 --> P1/2 | Trial primary completion date: Nov 2015 --> Jun 2016 N=100 --> 120
- || derazantinib (ARQ 087) / Merck (MSD)
P1/2 data, Enrollment change, Metastases: Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations (clinicaltrials.gov) - Jun 19, 2014
P1, N=100, Recruiting, Sponsor: ArQule
N=100 --> 120 N=60 --> 100
- ||| derazantinib (ARQ 087) / Merck (MSD)
New P1 trial, P1/2 data, Metastases: Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations (clinicaltrials.gov) - Dec 17, 2012
P1, N=60, Recruiting, Sponsor: ArQule
- ||| derazantinib (ARQ 087) / Merck (MSD)
Enrollment open, P1/2 data, Metastases: Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations (clinicaltrials.gov) - Dec 17, 2012
P1, N=60, Recruiting, Sponsor: ArQule
N=60 --> 100 Not yet recruiting --> Recruiting