NCT06622057

D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 195 (estimated)
• Sponsor: InnoPharmax Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Biliary Tract Cancer (BTC)

Interventions

Type	Name	Description
DRUG	D07001-Softgel Capsules	D07001-softgel capsule is an oral gemcitabine.
DRUG	Placebo	Placebo has the same excipient with D07001-softgel but without active pharmaceutical ingredients (APIs)
COMBINATION_PRODUCT	Capecitabine	Capecitabine, a fluoropyrimidine carbamate derivative, is an oral tumor activator and selective cytotoxic agent.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-10-01
• Last updated: 2026-04-14

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study