This study contains of 2 potential treatment arms, one including the experimental drug (Amphinex) and in addition to up to 8 cycles of; gemcitabine and cisplatin, the other arm includes only the gemcitabine and cisplatin. Even if you will not receive the experimental treatment you will receive what is considered standard of care for your disease.

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Study Name FIDES-01: A pivotal study of derazantinib in patients with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) and FGFR2 gene fusions or FGFR2 gene mutations or amplifications ClinicalTrials.gov Identifier (if applicable) NCT03230318 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name Please go to ClinicalTrials.gov to view…

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Study Name A Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in ClinicalTrials.gov Identifier (if applicable) NCT04057365 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Immunotherapy Study Center Institution Name Massachusetts General Hospital Cancer Center Institution Address 55 Fruit St City Boston State Massachusetts Zip Code…

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This is a global Phase 2 study for 2nd line treatment of patients with advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other FGFR genetic alteration. Patients must have been previously treated with gemcitabine chemotherapy or combination chemotherapy with gemcitabine.

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The PROOF Trial is a global Phase 3 study enrolling patients with advanced/metastatic cholangiocarcinoma who have a FGFR2 gene fusion/translocation. Patients must not have received systemic anti-cancer treatment for advanced disease. Patients are randomized to receive either oral infigratinib (BGJ398) or standard chemotherapy (gem/cis).

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Patients with intrahepatic cholangiocarcinoma who enroll in this study will receive either Melphalan with the investigational Hepatic Delivery System (called Melphalan/HDS) or Cisplatin and Gemcitabine alone, which is standard of care. Patients who enroll will receive gem/cis followed by melphalan, compared to gem/cis.

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This is an open-label, nonrandomized, Phase 1 dose-escalation, dose-expansion, and Phase 2 study targeting tumors with FGF/FGFR aberrations. The purpose of the study is to evaluate the safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of TAS-120 in patients with advanced solid tumors with and without FGF/FGFR-related abnormalities.

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Study Name Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations ClinicalTrials.gov Identifier (if applicable) NCT01948297 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name The University of Texas MD Anderson Cancer Center Institution Address 1515 Holcombe Blvd City Houston…

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FGFR gene abnormalities have been linked to various cancers. TAS-120 is an inhibitor of FGFR and therefore is being studied as a therapy for cancer. TAS-120 is a pill that you will take every day. You will see a doctor every 21 days, but you may have blood tests performed more often. You will have your cancer re-staged every 6-9 weeks.

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This Phase II clinical trial will establish the effectiveness of BGJ398 in patients harboring the FGFR2 gene fusion/translocation, which are errors in the DNA. Adult patients with histologically or cytologically confirmed (tumor biopsy), advanced or metastatic cholangiocarcinoma harboring the FGFR2 gene fusion/ translocation are eligible for enrollment. Phase II clinical trials give doctors more information about the safety of the drug and how well it works.

Approximately 55 adult patients over age 18, both male and female will be enrolled. All patients will receive oral BGJ398, once daily, on a three weeks on (21 days), one week off (7 days) schedule

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ClarIDHy is Phase 3, multicenter, randomized (people are allocated by chance to receive one of clinical interventions) double-blind (neither the participant nor the investigator know who is receiving AG-120 or the placebo) of orally administered AG-120 for patients with advanced cholangiocarcinoma and an IDH1 gene mutation.

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This study will enroll patients with advanced cancers (including cholangiocarcinoma) that have an NTRK/ROS1/ALK gene rearrangement (also called gene fusions), which may be primary causes of cancer. This study will evaluate if an investigational drug, Entrectinib (also known as RXDX-101), can block the growth of cancer cells caused by NTRK/ROS1/ALK gene rearrangements.

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This phase 2 study will enroll patients of all tumor types including cholangiocarcinomas who have a specific abnormality in the tumor called a fusion of one of the cancer cell’s NTRK genes (NTRK -1, -2, or -3) which may cause the cholangiocarcinoma to grow. The study drug, LOXO-101, is a capsule and acts by blocking the effects of the NTRK fusions

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