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.
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
Drug | Synonyms | Arms |
---|
BGJ398 | | BGJ398 |
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
Name | Type | Description | Interventions |
---|
BGJ398 | Experimental | 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. | |
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