A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

• Status: Completed
• Trial end date: 2018-10-08
• Target enrollment: 0
• Participant gender: All

Summary

The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Infigratinib

Criteria

Inclusion Criteria:

• Patients with histologically/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer treatment exists

• Adequate bone marrow function

• Adequate hepatic and renal function

• Adequate cardiovascular function

• Contraception.

• For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing.

• For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period

Exclusion Criteria:

• Patients with primary CNS tumor or CNS tumor involvement

• Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis

• History and/or current evidence of ectopic mineralization/ calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymphnodes and asymptomatic coronary calcification

• Current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination.

• History or current evidence of cardiac arrhythmia and/or conduction abnormality

• Women who are pregnant or nursing.

Other protocol-defined inclusion/exclusion criteria may apply