Clinical Trials /

BGJ398 for Patients With Tumors With FGFR Genetic Alterations

NCT02160041

Description:

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.

Related Conditions:
  • Cancer
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">BGJ398</span> for Patients With Tumors With <span class="go-doc-concept go-doc-biomarker">FGFR</span> Genetic Alterations

Title

  • Brief Title: BGJ398 for Patients With Tumors With FGFR Genetic Alterations
  • Official Title: Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 6 - BGJ398 for Patients With Tumors With FGFR Genetic Alterations
  • Clinical Trial IDs

    NCT ID: NCT02160041

    ORG ID: CBGJ398XUS04

    Trial Conditions

    Solid Tumor

    Hematologic Malignancies

    Trial Interventions

    Drug Synonyms Arms
    BGJ398 BGJ398

    Trial Purpose

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

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    BGJ398 Experimental BGJ398 will be 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. BGJ398

    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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Clinical benefit rate associated with BGJ398 treatment

    Secondary Outcome Measures

    Overall Response (OR) or Partial Response (PR) or greater

    Progression-Free Survival

    Overall survival

    Duration of Response

    Safety and Tolerability

    Trial Keywords

    Solid tumor malignancy

    hematologic malignancy

    mutation

    translocations

    amplifications,

    fusions

    signature

    FGFR

    ligand

    BGJ398

    SIGNATURE