A long-term safety study of oral infigratinib

JRCT ID: jRCTs041180017

Registered date:12/12/2018

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Advanced solid tumors with FGF-R1 or FGF-R2 amplification FGF-R3 mutation or other FGF-R alteration.
• Date of first enrollment: 07/02/2019
• Target sample size: 1
• Study type: Interventional
• Intervention(s): Oral administration of infigratinib 50 mg once a day

Outcome(s)

• Primary Outcome: Long term safety
• Secondary Outcome: Progression-free survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who are on Infigratinib for 6 months or more at the time of enrollment and have been confirmed to have short term safety and efficacy.
2. Measurable or non-measurable (but evaluable) disease as determined by RECIST ver 1.1. In endocrine tumors, endocrine laboratory findings could also be evaluated.
3. ECOG performance status 0-1.
4. The patient must be able to read and/or understand and must provide written evidence of informed consent as approved by certified review board.
5. Adequate bone marrow function:
1) ANC greater than or equal to 1,500/mm3.
2) Platelets greater than or equal to 7.5 x 104/mm3 without transfusions.
3) Hemoglobin greater than or equal to 10.0 g/dL.
6. Adequate hepatic and renal function:
1) Total bilirubin less than or equal to 1.5 x ULN.
2) AST/SGOT and ALT/SGPT less than or equal to 2.5 x ULN (If liver metastasis AST and ALT less than or equal to 5 x ULN).
3) Serum creatinine less than or equal to ULN.
4) Calculated or measured creatinine clearance greater than 75% LLN.
5) Proteinuria less than or equal to Grade 1 (dipstick or 24hrs urine analysis).
7. Calcium-phosphate homeostasis:
1) Serum inorganic phosphorus (Pi) less than or equal to 1.5 x ULN.
2) Normal serum ionized (i) calcium (Ca).
8. Adequate cardiovascular function:
1) NYHA grade less than or equal to 2.
2) Ejection fraction greater than or equal to 45%.
3) QTc interval less than or equal to 470 msec.
(Note: Medication used to normalize blood pressure and heart rate are permitted during the study)
9. Recovery from all adverse events of previous systemic anti-cancer therapies to baseline or Grade less than or equal to 1, except for:
1) Alopecia
2) Stable neuropathy of Grade less than or equal to 2 which was induced by prior cancer treatment.

Exclude criteria

1. Patients with history and or current evidence of endocrine alteration of calcium phosphate homeostasis, e.g. parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc.
2. Any other condition that would, in the investigators judgment, contraindicate the patients participation in the clinical study due to safety concerns or compliance with clinical study procedures e.g. uncontrolled diabetes mellitus, infection inflammation, intestinal obstruction, unable to swallow capsules, etc.

Related Information

• Primary Sponsor: Ando Yuichi