DeLiver-FGFR: A Pivotal Trial of ARQ 087 in Subjects with FGFR2 Gene Fusion Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma

Study Name
DeLiver-FGFR: A Pivotal Trial of ARQ 087 in Subjects with FGFR2 Gene Fusion Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
ClinicalTrials.gov Identifier (if applicable)
NCT03230318
Clinical Trial Category (check all that apply)
  • Beyond First Line Therapy
  • Targeted Therapy
Study Center
Institution Name
ArQule, Inc. (Study Sponsor)
Institution Address
One Wall Street
City
Burlington
State
Massachusetts
Zip Code
01803
Phone
(781) 994-0300
Website
https://www.arqule.com/
List additional Institutions (include address, phone number, and website)
To find a study near you or to learn more about this study, please contact ArQule at (781) 994-0300 or ClinicalTrials@arqule.com
Winship Cancer Institute of Emory University, Atlanta, GA, USA
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA
MD Anderson Cancer Center, Houston, TX, USA
Mayo Clinic – Arizona, Phoenix – Scottsdale, AZ, USA
Mayo Clinic – Florida, Jacksonville, FL, USA
Vanderbilt-Ingram Cancer Center, Nashville, TN, USA
University of Washington Medical Center, Seattle, WA, USA
Study Contacts
Principal Investigator
ArQule, Clinical Development
P.I. Phone
(781) 994-0300
P.I. Email
ClinicalTrials@arqule.com
Study Coordinator
ArQule, Clinical Development
Study Coordinator Phone
(800) 373-7827
Study Coordinator Email
ClinicalTrials@arqule.com
OVERVIEW – in layman’s terms (150 words max)
FGFR2 genetic alterations (changes) are associated with different types of cancer. A drug that inhibits the activity of FGFR2 may be beneficial for the treatment of these cancers. In a recent trial, patients with intrahepatic cholangiocarcinoma with a genetic alteration known as “FGFR2 gene fusion”, benefited the most from treatment with ARQ 087.
Enrollment
Approximately 100 patients with FGFR2 gene fusion positive intrahepatic cholangiocarcinoma will be enrolled at about 50 sites in the US, Canada, and Europe
Study Start Date
08/01/2017
Estimated Completion Date
03/31/2021
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • The purpose of this study is to find out if ARQ 087 is safe and effective in patients with advanced or inoperable FGFR2 gene fusion positive intrahepatic cholangiocarcinoma.
Inclusion Criteria – Patients Must:
  • Adult patients with confirmed diagnosis of intrahepatic cholangiocarcinoma who have received one prior treatment with gemcitabine plus cisplatin (or oxaliplatin) for advanced intrahepatic cholangiocarcinoma. Patients should have evidence of progressive disease following prior regimen or, if prior treatment discontinued due to toxicity, must have continued evidence of measurable or evaluable disease. Patients must be willing to undergo a biopsy or have sufficient archival tissue that will be submitted for genetic testing.
  • Please visit www.ClinicalTrials.gov, NCT03230318, for a complete list of Inclusion Criteria
Exclusion Criteria – Patients Must NOT:
  • Previous treatment with any FGFR inhibitors (e.g., ponatinib, dovitinib, AZD4547, BGJ398, etc.) is not allowed. Patients with an uncontrolled serious eye, cardiac, neurological, or gastrointestinal diseases may be not eligible to the study.
  • Please visit www.ClinicalTrials.gov, NCT03230318, for a complete list of Exclusion Criteria
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • Results of the genetic test to confirm if the patient has an FGFR2 gene fusion are required before beginning the study treatment. Patients can be enrolled based on the locally performed testing; if it was not done before the patient is asked to consider this study, the test will be provided as part of the clinical trial.
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • Side effects observed in more than 5% of patients treated with ARQ 087 include tiredness, lack of energy, loss of appetite, nausea, vomiting, dry mouth, change in taste, changes in laboratory tests (e.g., increase in alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase), dry eye, blurred vision, and conjunctivitis (or pink eye). These side effects may be caused by ARQ 087; they however, may very well be caused by other medications given at the same time or by the underlying disease.
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