Phase II Clinical Study of Utidelone Capsule (UTD2) in Patients With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Sponsor
Beijing Biostar Pharmaceuticals Co., Ltd.
Study ID
NCT07044349
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Utidelone capsule 75mg/m2/d QD — DRUG
    75mg/m2/d, QD, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.
  • Utidelone capsule 40mg/m2/d BID — DRUG
    40mg/m2/d, BID, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.
  • Utidelone capsule 50mg/m2/d BID — DRUG
    50mg/m2/d, BID, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.
  • Utidelone capsule 35mg/m2/d BID — DRUG
    35mg/m2/d, BID, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.

Study Details

This is an open, multicenter, phase II clinical study enrolling patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer to evaluate the safety and efficacy of Utidelone Capsules. Approximately 72 patients will be included in this study.

Key Dates

First listed
Jun 30, 2025
Start date
Sep 30, 2025
Status verified
Jun 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
  • Experimental: Cohort 2 initial group
  • Experimental: Cohort 2 escalation group
  • Experimental: Cohort 2 de-escalation group

Primary Outcome Measure

Dose-limiting toxicity (DLT) and the maximum tolerated dose of the BID administration regimen [ Time Frame: Until 21 days after the first dose of treatment ]

Central Contacts

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