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

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

  • ORG STUDY ID: CBGJ398XUS04
  • NCT ID: NCT02160041

Conditions

  • Solid Tumor
  • Hematologic Malignancies

Interventions

DrugSynonymsArms
BGJ398BGJ398

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
BGJ398ExperimentalBGJ398 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.
  • 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Clinical Benefit Rate (CBR) Associated With BGJ398 Treatment
Time Frame:16 weeks
Safety Issue:
Description:Tumor Response: Overall response rate (ORR) and clinical benefit rate (CBR) for solid tumor (non-lymphoma) which excludes 3 TIO and 1 Lymphoma patients (hence 80 patients and not 84) Clinical benefit rate for patients with solid tumors were assessed using RECIST 1.1 and include responses of CR or PR or SD. For hematologic tumors other appropriate hematological response criteria may apply Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Secondary Outcome Measures

Measure:Overall Response (OR) or Partial Response (PR) or Greater
Time Frame:baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months
Safety Issue:
Description:The key secondary endpoint, OR, was determined by Investigator assessment for each tumor assessment and defined as responses of CR and PR per RECIST version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measure:Progression-Free Survival (PFS)
Time Frame:every 8 weeks until death, assessed up to 24 months
Safety Issue:
Description:Kaplan-Meier estimates of PFS timing, months Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause
Measure:Kaplan-Meier Estimates of PFS Rate, % (95% CI)
Time Frame:Months 1, 2, 3, 4, 5, 6, 12, 18, 24
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:every 8 weeks until death, assessed up to 36 months
Safety Issue:
Description:Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause
Measure:Kaplan-Meier Estimates of Survival Rate, % (95% CI)
Time Frame:months 3, 6, 9, 12, 24
Safety Issue:
Description:Overall survival (OS) is the time from the date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last contact.
Measure:Number of Participants With 99 Day Minimum Duration of Response (DOR)
Time Frame:baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months
Safety Issue:
Description:The duration of response (PR or greater) applies only to patients whose best response was PR or greater. It is defined as the Ttime from the first documented response to the date first documented disease progression or relapse or death due to any cause

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • Solid tumor malignancy
  • hematologic malignancy
  • mutation
  • translocations
  • amplifications,
  • fusions
  • signature
  • FGFR
  • ligand
  • BGJ398

Last Updated

June 18, 2019