Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
A study to investigate the effects of the drug ARQ 087 in patients who have a type of bile duct cancer that cannot be operated on, or has spread, called Advanced Intrahepatic Cholanciocarcinoma. Patients will have a positive genetic test for FGFR2 Gene Fusion. Uno studio per valutare gli effetti del farmaco ARQ 087 in pazienti che hanno un tipo di tumore al dotto biliare molto esteso o che non possono essere operati, chiamato Colangiocarcinoma Intraepatico. I pazienti sono positivi alla fusione del gene FGFR2
Excerpt:...Not currently eligible for curative local or surgical therapyTo be enrolled in the study, once the FGFR2 gene fusion status is determined, each prospective subject must meet all of the following inclusion criteria:1. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
Excerpt:...Substudy 1: FGFR2 fusion status based on the following assessments: a) If central laboratory designated by...
More C2 evidence
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations
Excerpt:...Patients eligible for enrollment in the Expanded Cohort must have documented and/or confirmed FGFR genetic aberrations, including iCCA with FGFR2 gene fusion....
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
A Phase 1/2 Study of ARQ 087 in Adult Subjects with Advanced Solid Tumors with FGFR Genetic Alterations Studio di fase I/II con ARQ 087 in soggetti adulti con Tumori solidi in stadio avanzato che presentino alterazione genetica FGFR
Excerpt:...All subjects eligible for enrollment in the Expanded Cohort must have documented and/or confirmed FGFR genetic alterations, including iCCA with FGFR2 gene fusion. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
A Clinical Study to Evaluate Safety and Efficacy of ARQ 087 in Chinese Inoperable, Recurrent or Metastatic Intrahepatic Cholangiocarcinoma Subjects With Advanced Solid Tumors and FGFR2 Gene Fusion Positive Who Failed at Least First-Line Systemic Therapy
Excerpt:...FGFR2 gene fusion confirmed with a central laboratory FISH testing (Applicable to Stage 2). ...
Less C2 evidence
Evidence Level:Sensitive: D – Preclinical
Title:
The FGFR-inhibitor derazantinib (DZB) is active in PDX-models of GI-cancer with specific aberrations in FGFR.
Excerpt:Known driver-mutations were associated with partial-responses (best dT/C = 0.42), but models with FGFR-fusions, especially FGFR2-fusions, were very sensitive leading to stasis or strong-regression, particularly in gastric cancer. High-expression of FGFR2 was also associated with strong responses….DZB showed convincing activity in GIC-models with FGFR-fusions and/or high expression.