Ignite Creation Date:
2024-05-06 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05198479
Status:
RECRUITING
Last Update Posted:
2023-10-11
First Post:
2022-01-06
Brief Title:
Phase II 177Lu-DOTATATE Study in Metastatic NPC With a Safety Run-in
Sponsor:
National Cancer Centre Singapore
Organization:
National Cancer Centre Singapore
Study Overview
Official Title:
A Biomarker Enrichment Phase II Study of 177Lu-DOTATATE in Metastatic Nasopharyngeal Cancer With a Safety Run-in
Status:
RECRUITING
Status Verified Date:
2023-10
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:
SG-AAA-II-01
Brief Summary:
This study is the first phase II study of 177Lu-DOTA0-Tyr3-Octreotate in metastatic NPC Patients whom have failed 2 or more lines of therapy or exhausted standard therapy and are avid on 68Ga-DOTATATE imaging will be eligible to receive up to 4 cycles of 177Lu-DOTA0-Tyr3-Octreotate The primary outcome will be progression free survival at 6 months
Detailed Description:
This would be an open label single arm single centre phase II study designed to evaluate the efficacy of 177Lu-DOTA0-Tyr3-Octreotate in Metastatic NPC
Patients will first need to go for a 68Ga-DOTATATE scan to determine if they are suitable for 177Lu-DOTA0-Tyr3-Octreotate therapy AHern single stage phase II design AHern 2001 will be used for conducting the trial The null hypothesis that the true PFS rate at 6 months is 10 will be tested against the alternate hypothesis of 25 A total number of 25 patients will be recruited If there are 5 or more patients who are alive and progression free among these 25 patients at 6 months we reject the null hypothesis and claim that the treatment is promising
The design controls the type I error rate at 98 and yields a power of 786 when the true PFS rate at 6 months is 25 The first 5 patients will receive 180mCi of 177Lu-DOTA0-Tyr3-Octreotate for the first cycle followed by 200mCi for the remaining 3 cycles if there are no Grade 2 toxicities after the first cycle If there are G2 toxicities the remaining cycles will proceed at 180mCi A safety review will be done after the first 5 patients If there are no significant toxicities the remaining patients will receive 200mCi for 4 cycles If there are significant toxicities in patients receiving 200mCi for the 2nd to 4th cycle the remaining patients will receive 180mCi for 4 cycles If there are significant toxicities in patients receiving 180mCi for the 2nd to 4th cycle the remaining patients will receive 160mCi for 4 cycles Dosimetry scans will be done after each cycle of 177Lu-DOTA0-Tyr3-Octreotate at 1h and 96h Safety and tolerability of 177LuDOTA0-Tyr3-Octreotate will be assessed for the duration of study treatment
FDG PETCT scan and 68Ga-DOTATATE scan will be performed at baseline and after cycle 1 week 4 and cycle 4 week 28 CT scans will be done at week 12 24 then 3-monthly starting from week 40 177Lu-DOTA0-Tyr3-Octreotate treatment will be continued until progression of disease unacceptable toxicity or another discontinuation criterion is met In the case of toxicity dose adjustment is permitted A treatment cycle is eight weeks 56 days and will be repeated without therapy interruption for 4 cycles unless there is dose limiting toxicities
Patients will first need to go for a 68Ga-DOTATATE scan to determine if they are suitable for 177Lu-DOTA0-Tyr3-Octreotate therapy AHern single stage phase II design AHern 2001 will be used for conducting the trial The null hypothesis that the true PFS rate at 6 months is 10 will be tested against the alternate hypothesis of 25 A total number of 25 patients will be recruited If there are 5 or more patients who are alive and progression free among these 25 patients at 6 months we reject the null hypothesis and claim that the treatment is promising
The design controls the type I error rate at 98 and yields a power of 786 when the true PFS rate at 6 months is 25 The first 5 patients will receive 180mCi of 177Lu-DOTA0-Tyr3-Octreotate for the first cycle followed by 200mCi for the remaining 3 cycles if there are no Grade 2 toxicities after the first cycle If there are G2 toxicities the remaining cycles will proceed at 180mCi A safety review will be done after the first 5 patients If there are no significant toxicities the remaining patients will receive 200mCi for 4 cycles If there are significant toxicities in patients receiving 200mCi for the 2nd to 4th cycle the remaining patients will receive 180mCi for 4 cycles If there are significant toxicities in patients receiving 180mCi for the 2nd to 4th cycle the remaining patients will receive 160mCi for 4 cycles Dosimetry scans will be done after each cycle of 177Lu-DOTA0-Tyr3-Octreotate at 1h and 96h Safety and tolerability of 177LuDOTA0-Tyr3-Octreotate will be assessed for the duration of study treatment
FDG PETCT scan and 68Ga-DOTATATE scan will be performed at baseline and after cycle 1 week 4 and cycle 4 week 28 CT scans will be done at week 12 24 then 3-monthly starting from week 40 177Lu-DOTA0-Tyr3-Octreotate treatment will be continued until progression of disease unacceptable toxicity or another discontinuation criterion is met In the case of toxicity dose adjustment is permitted A treatment cycle is eight weeks 56 days and will be repeated without therapy interruption for 4 cycles unless there is dose limiting toxicities
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