A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement
Purpose
The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement. Participants will: - Take lirafugratinib regularly as instructed by their study doctor. - Visit the clinic as instructed for checkups and tests. - Keep a diary recording each time a dose of lirafugratinib is taken.
Conditions
- FGFR2 Gene Fusion/Rearrangement
- Other Solid Tumors, Adult
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Unresectable, locally advanced, or metastatic solid tumor (other than CCA). - Documented FGFR2 gene fusion or rearrangement per local testing of blood and/or tumor. - Patient must have measurable disease per RECIST v1.1• Patient has ECOG performance status of 0-1. - Previously (>30 days) treated with ≥1 line of systemic therapy including chemotherapy (e.g., gemcitabine/cisplatin), immunotherapy, radiation therapy, or other approved therapies. - Subject has not received prior treatment with an FGFRi.
Exclusion Criteria
- An uncontrolled comorbidity. - Patient does not have adequate organ function (defined in protocol). - Patient has active infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) (defined in protocol). Patients with well-controlled HBV are eligible (defined in protocol). - QT interval corrected using Fridericia's formula (QTcF) > 480 msec or history of prolonged QT syndrome, Torsades de pointes or familial history of prolonged QT syndrome. - Clinically significant, uncontrolled cardiovascular disease. - CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Lirafugratinib |
Treatment with standard dose of lirafugratinib |
|
Recruiting Locations
Moffitt Cancer Center
Tampa, Florida 33612
Tampa, Florida 33612
Contact:
Moffitt Clinical Trials Information
1-855-470-6706
Moffitt Clinical Trials Information
1-855-470-6706
The University of Texas M.D. Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
Contact:
UT M.D. Anderson Cancer Center Clinical Trial Information
1-877-632-6789
UT M.D. Anderson Cancer Center Clinical Trial Information
1-877-632-6789
More Details
- Status
- Recruiting
- Sponsor
- Elevar Therapeutics