Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05927857
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-03
First Post:
2023-06-14
Brief Title:
Ramucirumab Cyramza Nal-IRI ONIVYDE and TrifluridineTipiracil Lonsurf in Second Line Metastatic Gastric Cancer
Sponsor:
National Health Research Institutes Taiwan
Organization:
National Health Research Institutes Taiwan
Study Overview
Official Title:
A Phase IbII Study of Ramucirumab Cyramza Nal-IRI ONIVYDE and TrifluridineTipiracil Lonsurf in Second Line Metastatic Gastric Cancer COOL Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
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:
Primary Objectives
In phase 1b cohort to determine MTD maximum tolerated dose of nal-IRI ONIVYDE in combination with Ramucirumab Cyramza and TAS-102 LONSURF
In phase II cohort to evaluate disease objective response rate ORR of Ramucirumab Cyramza nal-IRI ONIVYDE in combination with TAS-102 LONSURF Secondary Objectives
To evaluate disease control rate DCR
To evaluate progression-free survival PFS
To evaluate overall survival OS
To assess the safety profile
To study the blood biomarkers
In phase 1b cohort to determine MTD maximum tolerated dose of nal-IRI ONIVYDE in combination with Ramucirumab Cyramza and TAS-102 LONSURF
In phase II cohort to evaluate disease objective response rate ORR of Ramucirumab Cyramza nal-IRI ONIVYDE in combination with TAS-102 LONSURF Secondary Objectives
To evaluate disease control rate DCR
To evaluate progression-free survival PFS
To evaluate overall survival OS
To assess the safety profile
To study the blood biomarkers
Detailed Description:
Eligible patients will be treated with infusional nal-IRI ONIVYDE free form 506070 mgm2 over 90 minutes day 1 Ramucirumab 8 mgkg over 60 minutes day 1 in combination with oral TAS-102 LONSURF 30 mgm2bid day 1-5 every 14 days
Every 14 days count as one cycle
Patients will be treated until disease progression unacceptable toxicity or other condition meeting the off-study criteria
Scheme of phase 1b dose Level 0 to 2 will be tested with the following dose levels
Dose level 0 RamucirumabCyramza 8mgkg on day 1 nal-IRI ONIVYDE free form 50 mgm2 on day 1 plus TrifluridineTipiracil Lonsurf 30mgm2 on day 1-5 q2wk
Dose level 1 RamucirumabCyramza 8mgkg on day 1 nal-IRI ONIVYDE free form 60 mgm2 on day 1 plus TrifluridineTipiracil Lonsurf 30mgm2 on day 1-5 q2wk
Dose level 2 RamucirumabCyramza 8mgkg on day 1 nal-IRI ONIVYDE free form 70 mgm2 on day 1 plus TrifluridineTipiracil Lonsurf 30mgm2 on day 1-5 q2wk
Adaptive phase IB cohort
33 dose escalation will be applied for phase Ib cohort All treated patients of MTD dose level in phase 1b cohort will be incorporated into phase II cohort for final analysis No intra-patient dose escalation is allowed during DLT period Patients could only have dose modification after the DLT period G-CSF prophylaxis is not allowed in DLT period
Dose escalation rule Two to six patients will be enrolled in each cohort depending on cases with DLTs The starting dose is dose level 0 If none of the first 3 patients experiences DLT then dose escalation will proceed to the next cohort of patients If only 1 of 3 patients developed DLT the cohort will be expanded to 6 patients If more than 1 patient developed DLT at a certain dose levelgroup the dose levelgroup is considered intolerable to the patients If no more than 1 out of 6 patients experience DLT the dose levelgroup is considered tolerable A minimum of 6 evaluable patients will be treated at the MTD The MTD at which no more than 1 of the 6 patients experience DLT will be determined for the phase II cohort Based on results from phase IB cohort MTD will be determined All treated population in MTD cohort will be incorporated into phase II cohort for final analysis
Every 14 days count as one cycle
Patients will be treated until disease progression unacceptable toxicity or other condition meeting the off-study criteria
Scheme of phase 1b dose Level 0 to 2 will be tested with the following dose levels
Dose level 0 RamucirumabCyramza 8mgkg on day 1 nal-IRI ONIVYDE free form 50 mgm2 on day 1 plus TrifluridineTipiracil Lonsurf 30mgm2 on day 1-5 q2wk
Dose level 1 RamucirumabCyramza 8mgkg on day 1 nal-IRI ONIVYDE free form 60 mgm2 on day 1 plus TrifluridineTipiracil Lonsurf 30mgm2 on day 1-5 q2wk
Dose level 2 RamucirumabCyramza 8mgkg on day 1 nal-IRI ONIVYDE free form 70 mgm2 on day 1 plus TrifluridineTipiracil Lonsurf 30mgm2 on day 1-5 q2wk
Adaptive phase IB cohort
33 dose escalation will be applied for phase Ib cohort All treated patients of MTD dose level in phase 1b cohort will be incorporated into phase II cohort for final analysis No intra-patient dose escalation is allowed during DLT period Patients could only have dose modification after the DLT period G-CSF prophylaxis is not allowed in DLT period
Dose escalation rule Two to six patients will be enrolled in each cohort depending on cases with DLTs The starting dose is dose level 0 If none of the first 3 patients experiences DLT then dose escalation will proceed to the next cohort of patients If only 1 of 3 patients developed DLT the cohort will be expanded to 6 patients If more than 1 patient developed DLT at a certain dose levelgroup the dose levelgroup is considered intolerable to the patients If no more than 1 out of 6 patients experience DLT the dose levelgroup is considered tolerable A minimum of 6 evaluable patients will be treated at the MTD The MTD at which no more than 1 of the 6 patients experience DLT will be determined for the phase II cohort Based on results from phase IB cohort MTD will be determined All treated population in MTD cohort will be incorporated into phase II cohort for final analysis
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