| ClinicalTrials.gov Identifier |
| NCT04565275 |
| Institution Name |
| Arizona Oncology-HOPE Division |
| Institution Address (Street) |
| 603 N. Wilmot Rd., #151 |
| Institution City |
| Tuscon |
| Institution State |
| Arizona |
| Institution ZIP Code |
| 85711 |
| Institution Country |
| 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 |
