Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622057
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase III Randomized Double-blind Study of Combination Therapy With D07001-Softgel Capsules and Capecitabine vs Placebo and Capecitabine in Patients With Advanced BTC After Failed on Gemcitabine Platin and FOLFOX or Irinotecan Regimens
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The object of this trial is to evaluate the efficacy of D07001-softgel capsules capecitabine compared with placebo capecitabine by overall survival OS
Eligible patients with advanced biliary tract cancer BTC will be randomized 111 to receive either 60 mg D07001-softgel 100 mg D07001-softgel or placebo combine with capecitabine Treatment will be continued until disease progression death withdraw consent or completing 12 treatment cycles whichever occurs first
Eligible patients with advanced biliary tract cancer BTC will be randomized 111 to receive either 60 mg D07001-softgel 100 mg D07001-softgel or placebo combine with capecitabine Treatment will be continued until disease progression death withdraw consent or completing 12 treatment cycles whichever occurs first
Detailed Description:
This is a Phase III randomized double-blind multicenter placebo-controlled parallel-group study to evaluate the efficacy and safety of D07001-softgel capsules capecitabine tablets in participants with advanced BTC after failure on an intravenous gemcitabine and cisplatin-based and also failed on or refused FOLFOX or failed on irinotecan and fluorouracil regimen Approximately 195 participants approximately 65 per treatment arm will be randomized 111 to one of the following treatment arms
Oral D07001 softgel capsules 100 mgday capecitabine tablets 1000 mgm2 twice daily bid
Oral D07001 softgel capsules 60 mgday capecitabine tablets 1000 mgm2 bid
Oral placebo softgel capsules capecitabine tablets 1000 mgm2 bid A formal interim futility analysis will be conducted when approximately 80 participants have either experienced disease progression or death Study participants will continue study treatment until unacceptable toxicity disease progression death withdrawal of consent to treatment or completing 12 treatment cycles whichever comes first The EOT Visit will occur following unacceptable toxicity disease progression completing 12 treatment cycles or withdrawal of consent to treatment Follow-up PeriodVisits over phone call will be conducted for participants on 30 3 days every month and at 365 3 days following the EOT Visit
Oral D07001 softgel capsules 100 mgday capecitabine tablets 1000 mgm2 twice daily bid
Oral D07001 softgel capsules 60 mgday capecitabine tablets 1000 mgm2 bid
Oral placebo softgel capsules capecitabine tablets 1000 mgm2 bid A formal interim futility analysis will be conducted when approximately 80 participants have either experienced disease progression or death Study participants will continue study treatment until unacceptable toxicity disease progression death withdrawal of consent to treatment or completing 12 treatment cycles whichever comes first The EOT Visit will occur following unacceptable toxicity disease progression completing 12 treatment cycles or withdrawal of consent to treatment Follow-up PeriodVisits over phone call will be conducted for participants on 30 3 days every month and at 365 3 days following the EOT Visit
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