Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor, CNS Tumor, Recurrent WHO Grade II Glioma

In brief

The phase 1b study is aimed at determining the pediatric recommended phase 2 dose (RP2D) of Infigratinib. The phase 2 study will evaluate efficacy and safety of infigratinib.

Key facts

Study ID: NCT05222165
Run by: Helsinn Healthcare SA
People needed: 0
Starts: 2021-10-01
Expected to finish: 2022-12-16
Last updated by the study team: 2023-02-23

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Phase 1b:
Subject must be ≥ 3 to <18 years of age at the Screening visit.
Confirmed diagnosis of one of the following:
LGG (WHO Grade I or II glioma) based on histology, molecular, and clinical criteria concordant with the WHO Grading of Tumors of the Central Nervous System, including glial or mixed neuronal-glial tumor
Histologically/cytologically confirmed CNS tumor (other than LGG).
Histologically/cytologically confirmed advanced solid tumor.
Disease is recurrent or progressive after standard therapy (at least 1 prior standard therapy appropriate for tumor type and stage of disease unless available standard therapies are considered inadequate for the subject).
Phase 2 at screening:
Diagnosis of recurrent or progressive (at least 1 prior standard therapy) LGG (WHO Grade I or II glioma), including glial or mixed neuronal-glial tumor, based on histology, molecular, and clinical criteria concordant with the WHO Grading of Tumors of the Central Nervous System.
Age 3 years and older at screening visit.
Phase 1b/2 (all subjects) at screening:
Able to swallow and retain oral medication.
Willing to stop consumption of grapefruit, grapefruit juice, grapefruit hybrids, pomegranates, star fruits, pomelos, Seville oranges, or products containing juice of these fruits; and have not consumed these within 7 days before the first dose of study drug.
Willing and able to comply with scheduled visits, treatment plan, and laboratory tests.
Sex and Contraceptive/Barrier Requirements
Contraceptive and barrier use as well as pregnancy testing is required as appropriate for the age and sexual activity of pediatric and adult subjects and as required by local regulations.
Subjects can be male and female.
A legal guardian or caregiver must be able to accurately maintain the pediatric subject's take-home record, including items of general health.

You may not qualify if…

Prior treatment with a FGFR1-3 selective inhibitor.
Known serious active infection or any clinically significant systemic illness, which in the Investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the subject's ability to tolerate the study drug.
Received anti-convulsant drugs that are strong inducers of CYP3A4 (i.e., carbamazepine, phenobarbital, phenytoin) within 4 weeks before starting study treatment.
Currently receiving treatment with agents that are known strong and moderate inducers of CYP3A4 within 4 weeks from start of treatment or inhibitors of CYP3A4 within 1 week from start of treatment, including herbal preparations; medications which increase serum phosphorus and/or calcium concentration; use of a proton-pump inhibitors (e.g., omeprazole) within 4 days prior to start of study therapy or H2 receptor antagonists (e.g., famotidine) within 2 days prior to the start of study therapy.
Uncontrollable seizures.
Have current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/band keratopathy; corneal abrasion, inflammation, or ulceration; or keratoconjunctivitis, confirmed by ophthalmic examination. Subjects with asymptomatic ophthalmic conditions assessed by the Investigator to pose minimal risk for study participation may be enrolled in the study.
Have current evidence of endocrine alterations of calcium/phosphate homeostasis (e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis), unless well controlled.
Have a history and/or current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, vasculature, myocardium, and lung with the exception of calcified lymph nodes, minor pulmonary parenchymal calcifications, small renal cyst or stone calcifications, and asymptomatic coronary calcification.
Have impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (e.g., active ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
Had major surgery within 2 weeks of enrollment or not fully healed from open wound.

Where it is running

Lucile Packard Children's Hospital at Stanford University Medical Center — Palo Alto, California, United States
Children's National Hospital - Brain Tumor Institute — Washington D.C., District of Columbia, United States
Nicklaus Children's Hospital — Miami, Florida, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Duke Cancer Institute (DCI) - The Preston Robert Tisch Brain Tumor Center — Durham, North Carolina, United States
UPCM - Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
University of Alberta - Stollery Children's Hospital (SCH) — Edmonton, Alberta, Canada
McMaster Children's Hospital (MCH) — Hamilton, Ontario, Canada
University of Toronto - The Hospital for Sick Children (SickKids) — Toronto, Ontario, Canada
Universitaetsklinikum Heidelberg (UKHD) - Zentrum fuer Kinder- und Jugendmedizin - Klinik Kinderheilkunde III — Heidelberg, Baden-Wurttemberg, Germany

Full record on ClinicalTrials.gov

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