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
InnoPharmax Inc.
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.
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 \[b…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements. 2. Participant aged at least 18 years at the time of consent. 3. Participant has histopathological or cytologic diagnosis of unresectable, locally advanced or metastatic BTC (cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma). 4. Participant has measurable disease as assessed by central review by RECIST v1.1. 5. Participant must have failed on a gemcitabine + cisplatin-based chemotherapy, regardless of whether an immune checkpoint inhibitor, such…
Interventions
- DrugD07001-Softgel Capsules
D07001-softgel capsule is an oral gemcitabine.
- DrugPlacebo
Placebo has the same excipient with D07001-softgel but without active pharmaceutical ingredients (APIs)
- Combination ProductCapecitabine
Capecitabine, a fluoropyrimidine carbamate derivative, is an oral tumor activator and selective cytotoxic agent.
Locations (2)
- University Hospital Cleveland Medical CenterCleveland, Ohio
- Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City