Ignite Creation Date:
2024-05-06 @ 4:32 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05019794
Status:
UNKNOWN
Last Update Posted:
2022-06-27
First Post:
2021-07-28
Brief Title:
Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations
Sponsor:
LianBio LLC
Organization:
LianBio LLC
Study Overview
Official Title:
A Phase IIa of Infigratinib in Subjects With Locally Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma With FGFR2 Amplification or Other Advanced Solid Tumors With Other FGFR Alterations
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FGFR
Brief Summary:
Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor FGFR 1-3 This is a multicenter open-label single arm phase IIa study to evaluate the efficacy and safety of Infigratinib in subjects with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 genetic amplification or other advanced solid tumors with other FGFR genetic alternations who have failed in 2nd line or above treatment This trial includes 2 cohorts ie baskets with above mentioned indications
Detailed Description:
The subject will go through 4 periods including Pre-screen period screening period treatment period and follow up period
Pre-screening period up to 28 days For cohort 1 subject sign pre-screening ICF Inform consent subject will do tumor biopsy or provide FFPE samples before prescreening for FGFR2-amp detection by FISH from the central laboratory If the result is positive subjects can go through the main screening stage otherwise participants will be considered a prescreen failure subjects can go through the main screening stage otherwise participants will be considered a prescreen failure
Screening period All cohorts up to 28 days Subjects who had positive genetic result could sign main ICF for all the screening examinations and establish study baseline documents Only the eligible participants could enter the next treatment period
Treatment period Eligible subjects will be orally administered Infigratinib 125mg QD for 3 weeks on 1-week off in each 28-day cycle until the occurrence of unacceptable toxicity disease progression withdrawing informed consent death contact lost starting a new anticancer therapy etc whichever occurs first During this period subjects will be routinely assessed efficacy status by radiographic check at W9W17W25W33 After that subjects will be evaluated every 12 weeks until disease progression The safety assessment will be performed at cycle 1- 4
Follow up period Once a treatment discontinuation happens subjects should return to the hospital within 30 days to receive a complete safety examination Subjects with treatment discontinuation or disease progression should directly enter the follow-up period visit approximately every 3 months for survival status reporting until withdrawing informed consent death contact lost starting a new anti-cancer therapy etc whichever occurs first
Pre-screening period up to 28 days For cohort 1 subject sign pre-screening ICF Inform consent subject will do tumor biopsy or provide FFPE samples before prescreening for FGFR2-amp detection by FISH from the central laboratory If the result is positive subjects can go through the main screening stage otherwise participants will be considered a prescreen failure subjects can go through the main screening stage otherwise participants will be considered a prescreen failure
Screening period All cohorts up to 28 days Subjects who had positive genetic result could sign main ICF for all the screening examinations and establish study baseline documents Only the eligible participants could enter the next treatment period
Treatment period Eligible subjects will be orally administered Infigratinib 125mg QD for 3 weeks on 1-week off in each 28-day cycle until the occurrence of unacceptable toxicity disease progression withdrawing informed consent death contact lost starting a new anticancer therapy etc whichever occurs first During this period subjects will be routinely assessed efficacy status by radiographic check at W9W17W25W33 After that subjects will be evaluated every 12 weeks until disease progression The safety assessment will be performed at cycle 1- 4
Follow up period Once a treatment discontinuation happens subjects should return to the hospital within 30 days to receive a complete safety examination Subjects with treatment discontinuation or disease progression should directly enter the follow-up period visit approximately every 3 months for survival status reporting until withdrawing informed consent death contact lost starting a new anti-cancer therapy etc whichever occurs first
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