Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06202001
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-01-02
Brief Title:
Irinotecan TAS-102 Plus Bevacizumab as a Second-Line Therapy in mCRC Patients
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
Phase III Study of Irinotecan Plus TrifluridineTipiracil TAS-102 in Combination With Bevacizumab as a Second-Line Therapy for Patients With Metastatic Colorectal Cancer mCRC
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
None
Brief Summary:
In mCRC response to second-line chemotherapy is limited and few treatment options are available It is urgent to design an optimal second-line treatment regimen to improve the response rate and prolong the survival of patients with mCRC Several studies preliminarily demonstrated that irinotecan TAS-102 plus bevacizumab regimen could bring promising efficacy with a tolerable safety profile for patients with mCRC as a second-line treatment This phase III study was aimed to determine the recommended phase II dose RP2D of the combination of TAS-102 irinotecan and bevacizumab for future clinical trials in patients with mCRC refractory to both fluoropyrimidine and oxaliplatin and to evaluate its safety and preliminary efficacy
Detailed Description:
This was a single-arm open-label phase I dose-escalation study to establish the recommended phase II dose RP2D for the combination of TAS-102 irinotecan and bevacizumab and evaluate its safety
This study followed a classic 33 design in which patients received escalating doses of TAS-102 20 25 30 or 35 mgm2dose administered twice daily for days 1-5 and irinotecan 135 150 165 or 180 mgm2 on day 1 with a fixed dose of bevacizumab 5 mgkg on day 1 repeated every 14 days Initially three patients will receive therapy at dose level 1 If dose-limiting toxicity DLT occurred an additional three patients were enrolled at the same dose level If none of the first three patients or less than two of the six patients exhibited DLT then the study regimen was escalated to a higher dose level If two or more DLTs occurred the study regimen was reduced to a lower dose level
The maximum tolerated dose MTD was defined as the highest dose level at which less than one-third of evaluable patients treated had a DLT during the first or second cycle of drug administration The RP2D was defined as the MTD At least six patients at the MTD or RP2D were needed to estimate these doses accurately
Treatment was continued until RECIST-defined disease progression or clinical disease progression unacceptable toxicity patient request to withdraw treatment and a treatment-free period of 30 consecutive days
Adverse events AEs were graded based on the National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE version 50
The response was assessed by the investigator according to RECIST version 11
This study followed a classic 33 design in which patients received escalating doses of TAS-102 20 25 30 or 35 mgm2dose administered twice daily for days 1-5 and irinotecan 135 150 165 or 180 mgm2 on day 1 with a fixed dose of bevacizumab 5 mgkg on day 1 repeated every 14 days Initially three patients will receive therapy at dose level 1 If dose-limiting toxicity DLT occurred an additional three patients were enrolled at the same dose level If none of the first three patients or less than two of the six patients exhibited DLT then the study regimen was escalated to a higher dose level If two or more DLTs occurred the study regimen was reduced to a lower dose level
The maximum tolerated dose MTD was defined as the highest dose level at which less than one-third of evaluable patients treated had a DLT during the first or second cycle of drug administration The RP2D was defined as the MTD At least six patients at the MTD or RP2D were needed to estimate these doses accurately
Treatment was continued until RECIST-defined disease progression or clinical disease progression unacceptable toxicity patient request to withdraw treatment and a treatment-free period of 30 consecutive days
Adverse events AEs were graded based on the National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE version 50
The response was assessed by the investigator according to RECIST version 11
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