A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

Novartis

Status and phase: Completed; Phase 1

Conditions: Squamous Lung Cancer With FGFR1 Amplification; Advanced Solid Tumors With FGFR2 Amplication; Bladder Cancer With FGFR3 Mutation or Fusion; Advanced Solid Tumors With FGFR1 Amplication; Advanced Solid Tumors With FGFR3 Mutation; Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3

Treatments: Drug: BGJ398

Study type: Interventional

Funder types: Industry

Identifiers

NCT01004224

2009-010876-73 (EudraCT Number)

CBGJ398X2101

Details and patient eligibility

About

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

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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208 participants in 1 patient group

BGJ398

Experimental group

Treatment:

Drug: BGJ398