BGJ398 for Patients With Tumors With FGFR Genetic Alterations
Condition: Solid Tumor; Hematologic Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms
Intervention: BGJ398
Intervention description: BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
Intervention MeSH terms: Infigratinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Solid tumor malignancy; hematologic malignancy; mutation; translocations; amplifications,; fusions; signature; FGFR; ligand; BGJ398

Summary:

      The purpose of this signal seeking study was to determine whether treatment with BGJ398
      demonstrates sufficient efficacy in select FGFR pathway-regulated solid tumors and/or
      hematologic malignancies to warrant further study.
    

Eligibility criteria:

        Inclusion Criteria:

        Patient has a confirmed diagnosis of a select solid tumor (except with a primary diagnosis
        of Urothelial cell carcinoma, Cholangiocarcinoma, Endometrial cancer, and Glioblastoma
        multiforme) or hematologic malignancies and is in need of treatment because of progression
        or relapse.

        Patient's tumor has been evaluated and pre-identified as having a tumor with a FGFR genetic
        alteration. The qualifying alteration must be assessed and reported by a CLIA-certified
        laboratory.

        Patient must have received at least one prior treatment for recurrent, metastatic and /or
        locally advanced disease and for whom no standard therapy options are anticipated to result
        in a durable remission.

        Patient must have progressive and measurable disease per RECIST 1.1. or other appropriate
        hematological response criteria.

        Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

        Exclusion Criteria:

        Patient has received prior treatment with BGJ398

        Patients with Central Nervous System (CNS) metastasis or leptomeningeal carcinomatosis

        Patient has received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for
        nitrosourea, antibodies or mitomycin-C) prior to starting study drug.

        Patients with acute or chronic pancreatitis

        Patients with impaired cardiac function or clinically significant cardiac diseases

        History and/or current evidence of extensive tissue calcification

        Use of medications that increase serum levels of phosphorus and/or calcium

        Current evidence of corneal or retinal disorder/keratopathy

        History and/or current evidence of renal or endocrine alterations of calcium/phosphate
        homeostasis

        Patients with another primary malignancy within 3 years prior to starting study treatment,
        with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or
        other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix