Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
Study NCT ID:
NCT06622057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-30
First Post:
2024-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer
Sponsor:
InnoPharmax Inc.
Organization:
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:
2025-04
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 (1:1:1) 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 (1:1:1) 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 1:1:1 to one of the following treatment arms:
* Oral D07001 softgel capsules, 100 mg/day + capecitabine tablets (1000 mg/m2 twice daily \[bid\])
* Oral D07001 softgel capsules, 60 mg/day + capecitabine tablets (1000 mg/m2 bid)
* Oral placebo softgel capsules + capecitabine tablets (1000 mg/m2 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 Period/Visits 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 mg/day + capecitabine tablets (1000 mg/m2 twice daily \[bid\])
* Oral D07001 softgel capsules, 60 mg/day + capecitabine tablets (1000 mg/m2 bid)
* Oral placebo softgel capsules + capecitabine tablets (1000 mg/m2 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 Period/Visits 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:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: