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ICP-CL-00303

ClinicalTrials.gov Identifier
NCT04565275
Institution Name
Arizona Oncology-HOPE Division
Full Institution Address
603 N. Wilmot Rd., #151

Tuscon
Arizona
85711
United States
Institution Phone
(520) 668-5678
Institution Website
https://arizonaoncology.com
Additional Institutions
Rocky Mountain Cancer Centers, Aurora, Colorado
Mid Florida Hematology, Orange City, Florida
Minnesota Oncology HematologyAll updated information can be found on Clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT04565275?term=ICP-192&draw=2&rank=1
Principal Investigator
Sudhir Manda
Principal Investigator Phone
(520) 668-5678
Principal Investigator Email
stacey.kimbell@usoncology.com
Study Coordinator
Stacey Kimbell
Study Coordinator Phone
(520) 668-5678
Study Coordinator Email
stacey.kimbell@usoncology.com
Study Overview
1. Overview: ICP-192 is a novel, irreversible pan-FGFR inhibitor may overcome on-target resistance to first generation FGFR inhibitors (erdafitinib, pemigatinib, rogaratinib, infigratinib, derazatinib). ICP-192 is a highly selective pan-FGFR inhibitor, and has improved safety profiles in comparison to the first generation FGFR inhibitors.
Enrollment Information
Active/Recruiting
Study Start Date
20200925
Study End Date
20240415
Study Purpose

  • The study is a multi-center open-label, phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ICP-192 in patients with advanced solid tumors and FGFR gene alterations
Inclusion Criteria

  • Phase I: Patients with histologically or cytologically confirmed unresectable or metastatic advanced malignant solid tumors who have progressed under standard treatment or recurred after or were intolerant to all standard treatment regimens, or have no standard treatment available;
Exclusion Criteria

  • Have previously been treated with selective pan-FGFR molecular inhibitors or antibody drugs, except for the FGFR4 selective inhibitors
Required Tests Prior to Study

  • For dose escalation (Phase 1), there is no requirements for NGS testing prior to enter the study. Laboratory, CT scan, ECG and eye exams are required tests before begin study treatment
Potential Side Effects

  • increase phosphate in your blood

  • increase calcium in blood

  • can cause increase in liver function

  • increase triglyceride in blood

  • can cause diarrhea or loose stool

  • can cause blurred vision or visual change

  • can cause damage to kidney function
Financial Assistance Available
No