Online Trial Tracker - Larvol Sigma

Trial + Data / Events

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Region

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Primary compl

Study compl

derazantinib (ARQ 087) / Merck (MSD)

2020-004938-38: ADVANCE: A clinical study of Atezolizumab and Derazantinib for patients with advanced intrahepatic cholangiocarcinoma with gene FGFR2 fusions/rearrangements Die ADVANCE Studie: Eine einarmige, offene klinische Studie der Phase II zur Behandlung mit Atezolizumab und Derazantinib bei Patienten mit einem fortge-schrittenen intrahepatischen Cholangiokarzinom, das molekulare FGFR2 Alterationen (Gen-Fusionen/Rearrangements) aufweist

Not yet recruiting

Europe

Derazantinib, Derazantinib•2HCl / BAL087 / BAL0000087-001, Concentrate for solution for infusion, Capsule, hard, Tecentriq® 1.200 mg

Frankfurter Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, ROCHE Pharma AG, Basilea Pharmaceutica International Ltd.

Advanced non-resectable intrahepatic cholangiocarcinoma with positively confirmed FGFR2 fusion/rearrangements via NGS-Analysis, Advanced and inoperable intrahepatic bile duct cancer with positively confirmed FGFR2 genetic alterations, Diseases [C] - Cancer [C04]

FIDES-01, NCT03230318: Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma

	Data from FIDES-01 trial for FGFR2 fusion-positive intrahepatic cholangiocarcinoma at ESMO 2022
	Oct 2022 - Oct 2022: Data from FIDES-01 trial for FGFR2 fusion-positive intrahepatic cholangiocarcinoma at ESMO 2022
	Apr 2022 - Sep 2022 : Top-line data from FIDES-01 trial for FGFR2 fusion driven iCCA
	Positive Interim data from FIDES-01 cohort 2 for patients with locally advanced or metastatic intrahepatic cholangiocarcinoma
	Jan 2022 - Jan 2022: Positive Interim data from FIDES-01 cohort 2 for patients with locally advanced or metastatic intrahepatic cholangiocarcinoma
	Full efficacy and safety data from FIDES-01 trial for FGFR2 fusion-positive iCCA at ESMO
	Sep 2021 - Sep 2021: Full efficacy and safety data from FIDES-01 trial for FGFR2 fusion-positive iCCA at ESMO
	Positive Interim data from FIDES-01 cohort 2 for FGFR2 gene mutation or ampliﬁcation-positive patients with iCCA
	Mar 2021 - Mar 2021: Positive Interim data from FIDES-01 cohort 2 for FGFR2 gene mutation or ampliﬁcation-positive patients with iCCA
	Topline data from cohort 1 for iCCA with FGFR2 gene mutations
	Feb 2021 - Feb 2021: Topline data from cohort 1 for iCCA with FGFR2 gene mutations
	Completion of enrollment in P2 FIDES-01 study with derazantinib in bile duct cancer (iCCA)
	Jul 2020 - Jul 2020: Completion of enrollment in P2 FIDES-01 study with derazantinib in bile duct cancer (iCCA)
	Initiation of clinical program for intrahepatic cholangiocarcinoma
	Jul 2019 - Jul 2019: Initiation of clinical program for intrahepatic cholangiocarcinoma
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Completed

148

Europe, Canada, US, RoW

derazantinib

Basilea Pharmaceutica

Intrahepatic Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma

10/22

NCT05174650: Treatment of Atezolizumab and Derazantinib in Patients With Advanced iCCA With FGFR2 Fusions/Rearrangements

Recruiting

Europe

Atezolizumab, Tecentriq, Derazantinib, ARQ 087

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Intrahepatic Cholangiocarcinoma

12/25

08/26

NCT01752920 / 2015-001443-36: Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations

	PD data at AACR 2018 [screenshot]
	Apr 2018 - Apr 2018: PD data at AACR 2018 [screenshot]
	Update in intrahepatic cholangiocarcinoma with FGFR2-fusion [screenshot]
	Oct 2017 - Oct 2017: Update in intrahepatic cholangiocarcinoma with FGFR2-fusion [screenshot]
	Update in intrahepatic cholangiocarcinoma with FGFR2-fusion at ASCO 2017
	Jun 2017 - Jun 2017: Update in intrahepatic cholangiocarcinoma with FGFR2-fusion at ASCO 2017
	Update in intrahepatic cholangiocarcinoma with FGFR2-fusion
	Feb 2017 - Feb 2017: Update in intrahepatic cholangiocarcinoma with FGFR2-fusion
	Completion of enrollment of P1/2 trial in solid tumors including intrahepatic cholangiocarcinoma
	Dec 2016 - Dec 2016: Completion of enrollment of P1/2 trial in solid tumors including intrahepatic cholangiocarcinoma
	Trial update in iCCA
	Aug 2016 - Aug 2016: Trial update in iCCA
	In intrahepatic cholangiocarcinoma at ESMO GI 2016
	Jun 2016 - Jul 2016: In intrahepatic cholangiocarcinoma at ESMO GI 2016
	Update from P2 portion of P1/2 trial in iCCA
	Feb 2016 - Feb 2016: Update from P2 portion of P1/2 trial in iCCA
	In solid tumor patients with FGFR2 fusions
	Dec 2015 - Dec 2015: In solid tumor patients with FGFR2 fusions
	Intrahepatic cholangiocarcinoma (iCCA) patients with FGFR2 fusions
	Sep 2015 - Sep 2015: Intrahepatic cholangiocarcinoma (iCCA) patients with FGFR2 fusions
	ASCO 2015
	May 2015 - May 2015: ASCO 2015
	AACR 2015
	Apr 2015 - Apr 2015: AACR 2015
	For solid tumors (tumor type not specified)
	Nov 2014 - Nov 2014: For solid tumors (tumor type not specified)
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Completed

1/2

119

Europe, US

Derazantinib low dose range, Derazantinib middle dose range, Derazantinib high dose range, Derazantinib at recommended phase 2 dose (RP2D)

Basilea Pharmaceutica, ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

Solid Tumor

08/18



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