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NCT05065957

Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer

StatusTerminated
PhasePhase 2/3
Primary completion
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Record History

All 7 versions: 5 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial terminated Sponsor's reason: Dose-finding stage has been completed, and dose-expanding stage was not conducted due to design amendment. Show 6 more changesShow less
    • Primary endpoints: details revised at 1 of 2 entries
    • Final enrollment: 19 participants (planned 180)
    • Primary completion date changed from estimate of Jul 2026 to Jul 31, 2025
    • Eligibility criteria expanded, about 45 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Site details revised at 5 of 5 sites
  2. Eligibility criteria expanded, about 46 wordsv5
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 2 to 5
    • Start date changed from estimate of Apr 2022 to Mar 29, 2022
    • Eligibility criteria shortened, about 51 words
    • Secondary endpoints revised (5)
  4. Start date: Nov 2021 to Apr 2022v2
  5. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Incidence of adverse events (AEs)/ serious adverse event (SAEs)
Timeframe: From date of informed consent to 30-day follow-up visit for each subject
To assess disease control rate (DCR)
Timeframe: From date of randomization until the date of first documented progression, date of death from any cause, or date of withdraw the study for each subject, whichever came first, assessed up to 24 months

Secondary (5)

Phase IIa and IIb: Pharmacokinetics (PK) of gemcitabine (dFdC), difluorodeoxyuridine (dFdU), capecitabine, 5-FU, Tegafur, Gimeracil, and Oteracil potassium
Quality of life (QOL) will be assessed using the EORTC questionnaires
To assess Progression-free survival (PFS)
To assess Objective response rate (ORR)
To assess overall survival (OS)

Arms and interventions

Phase IIa:Dose-Finding StageExperimental

Level -5: 20 mg D07001-softgel capsules plus 625 mg/m\^2 Xeloda (or 20/30/40 mg TS-1). Level -4: 40 mg D07001-softgel capsules plus 625 mg/m\^2 Xeloda (or 20/30/40 mg TS-1). Level -3: 60 mg D07001-softgel capsules plus 625 mg/m\^2 Xeloda (or 20/30/40 mg TS-1). Level -2: 80 mg D07001-softgel capsules plus 625 mg/m\^2 Xeloda (or 20/30/40 mg TS-1). Level -1 (starting dose): 100 mg D07001-softgel capsules plus 625 mg/m\^2 Xeloda (or 20/30/40 mg TS-1). Level 1: 100 mg D07001-softgel capsules plus 800 mg/m\^2 Xeloda (or 30/40/50 mg TS-1). Level 2: 100 mg D07001-softgel capsules plus 1000 mg/m\^2 Xeloda (or 40/50/60 mg TS-1).

Phase IIb/III: Dose Expansion StageActive comparator

ASC+ D07001-softgel capsules plus Xeloda (or TS-1) ASC+mFOLFOX (5-FU+Oxalipatin+folinic acid)

Drugs: D07001-softgel capsules + Xeloda (or TS-1), mFOLFOX

Sites

5 sites in 1 country