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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
InnoPharmax Inc.
Study ID
NCT06622057
Phase
PHASE3
Status
Recruiting
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Conditions

  • Biliary Tract Cancer (BTC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 9, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
195 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: D07001-Softgel Capsules 60 mg + Capecitabine
    * D07001-softgel capsules, 60 mg/day, orally 3 times per week before lunch (on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle) * Capecitabine tablets (1000 mg/m2 bid) for 14 days (on Days 1 through 14 of a 21 day cycle) followed by a 7-day rest period. Capecitabine will be taken after breakfast and after dinner.
  • Experimental: D07001-Softgel Capsules 100 mg + Capecitabine
    * D07001-softgel capsules, 100 mg/day, orally 3 times per week before lunch (on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle) * Capecitabine tablets (1000 mg/m2 bid) for 14 days (on Days 1 through 14 of a 21 day cycle) followed by a 7-day rest period. Capecitabine will be taken after breakfast and after dinner.
  • Placebo Comparator: Placebo + Capecitabine
    * Placebo, orally 3 times per week before lunch (on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle) * Capecitabine tablets (1000 mg/m2 bid) for 14 days (on Days 1 through 14 of a 21 day cycle) followed by a 7-day rest period. Capecitabine will be taken after breakfast and after dinner.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From date of randomization until the date of death, assessed up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospital Cleveland Medical CenterClevelandOhio44106
Ava Lin
[email protected]
+886-2-8797-7607
Amit Mahipal (PRINCIPAL_INVESTIGATOR)

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By research site
University Hospital Cleveland Medical Center· Cleveland, OH

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