Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519110
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Neratinib Tablets Monotherapy for Advanced Solid Tumors With HER2 Mutations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-arm Open-label Multicenter Phase II Clinical Study of Neratinib Tablets Monotherapy in the Treatment of Advanced Solid Tumors With HER2 Mutations
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CVL009-C2001
Brief Summary:
Evaluating the efficacy of Neratinib tablets monotherapy in treating advanced solid tumors with HER2 mutations
Detailed Description:
This single-arm open-label multicenter Phase II clinical study is divided into three phases screening treatment and follow-up The screening phase occurs within 28 days prior to the first administration of the study drug During the treatment phase a 28-day cycle is used and tumor efficacy is assessed according to the RECIST 11 criteria Assessments are conducted at the end of the first cycle 3 days followed by imaging evaluations every 8 weeks until disease progression During the treatment period the investigator may increase the number of assessments based on clinical needs The study drug will be administered continuously until intolerable adverse reactions occur disease progression withdrawal of informed consent loss to follow-up death or study termination
The follow-up phase includes safety and survival follow-up Safety follow-up occurs within 28 days after the last administration of the study drug Survival follow-up is conducted every 12 weeks to collect the survival status of the subjects until their death loss to follow-up withdrawal from the study or study termination whichever occurs first
The follow-up phase includes safety and survival follow-up Safety follow-up occurs within 28 days after the last administration of the study drug Survival follow-up is conducted every 12 weeks to collect the survival status of the subjects until their death loss to follow-up withdrawal from the study or study termination whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None