Ignite Creation Date:
2024-05-06 @ 12:28 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03762122
Status:
TERMINATED
Last Update Posted:
2022-11-09
First Post:
2018-11-30
Brief Title:
Rogaratinib in Patients With Advanced Pretreated Squamous-cell Non-small Cell Lung Cancer SQCLC
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Fibroblast Growth Factor Receptor FGFR Inhibitor Rogaratinib in Patients With Advanced Pretreated Squamous-cell Non-small Cell Lung Cancer SQCLC Overexpressing FGFR mRNA A Multicenter Single Arm Phase II Trial
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to financial restructure of SAKK
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A recent investigation showed that a substantial proportion of patients with SQCLC 46 exhibit tumor overexpression of fibroblast growth factor receptor FGFR messenger ribonucleic acid mRNA and are potentially sensitive to FGFR-targeting treatment Rogaratinib is a novel pan-FGFR inhibitor which showed strong anti-tumor efficacy in pre-clinical models as a single agent in FGFR pathway-addicted tumor models SQCLC patients overexpressing tumor FGFR mRNA who will be included into this clinical trial do not have currently any alternative systemic treatment with a proven and clinically reasonable benefit
The objective of the trial is to determine clinical activity and safety of rogaratinib in patients with advanced SQCLC overexpressing tumor FGFR1-3 mRNA
The objective of the trial is to determine clinical activity and safety of rogaratinib in patients with advanced SQCLC overexpressing tumor FGFR1-3 mRNA
Detailed Description:
Squamous-cell lung cancer SQCLC is a distinct histologic subtype of non-small cell lung cancer NSCLC that is challenging to treat because of specific clinicopathologic characteristics older age advanced disease at diagnosis central location of tumors and the absence of molecular alterations which can be successfully treated with targeted therapy A recent investigation showed that a substantial proportion of patients with SQCLC 46 exhibit tumor overexpression of fibroblast growth factor receptor FGFR messenger ribonucleic acid mRNA and are potentially sensitive to FGFR-targeting treatment
Rogaratinib is a novel pan-FGFR inhibitor which showed strong anti-tumor efficacy in pre-clinical models as a single agent in FGFR pathway-addicted tumor models The clinical experience with rogaratinib comes from two ongoing phase I trials enrolling patients with refractory locally advanced or metastatic solid tumors who were selected based on tumoral overexpression of FGFR mRNA Such selection identifies patients with high FGFR tumor target levels due to DNA aberrations in FGFR-encoding genes and due to non-genetic and epigenetic regulation of FGFR expression incl promoter activation To date rogaratinib has shown to be well tolerated no dose-limiting toxicity with promising clinical activity in particular in bladder cancer
Despite the constant improvement in the treatment of patients with advanced lung cancer there is still a high-unmet medical need to develop new and highly active anticancer drugs for patients who have failed standard systemic treatment and have an otherwise very unfavorable prognosis SQCLC patients overexpressing tumor FGFR mRNA who will be included into this clinical trial do not have currently any alternative systemic treatment with a proven and clinically reasonable benefit
The objective of the trial is to determine clinical activity and safety of rogaratinib in patients with advanced SQCLC overexpressing tumor FGFR1-3 mRNA
Rogaratinib is a novel pan-FGFR inhibitor which showed strong anti-tumor efficacy in pre-clinical models as a single agent in FGFR pathway-addicted tumor models The clinical experience with rogaratinib comes from two ongoing phase I trials enrolling patients with refractory locally advanced or metastatic solid tumors who were selected based on tumoral overexpression of FGFR mRNA Such selection identifies patients with high FGFR tumor target levels due to DNA aberrations in FGFR-encoding genes and due to non-genetic and epigenetic regulation of FGFR expression incl promoter activation To date rogaratinib has shown to be well tolerated no dose-limiting toxicity with promising clinical activity in particular in bladder cancer
Despite the constant improvement in the treatment of patients with advanced lung cancer there is still a high-unmet medical need to develop new and highly active anticancer drugs for patients who have failed standard systemic treatment and have an otherwise very unfavorable prognosis SQCLC patients overexpressing tumor FGFR mRNA who will be included into this clinical trial do not have currently any alternative systemic treatment with a proven and clinically reasonable benefit
The objective of the trial is to determine clinical activity and safety of rogaratinib in patients with advanced SQCLC overexpressing tumor FGFR1-3 mRNA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None