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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBeijing Biostar Pharmaceuticals Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Participants who voluntarily sign the informed consent form, are willing and able to comply with the scheduled visits, study treatment plan, laboratory tests, and other study procedures.

Female participants aged ≥ 18 years when signing the informed consent form.

Pathologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Participants with at least one measurable lesion as defined per RECIST v1.1.

Disqualifiers

The best overall response during the first-line platinum-based treatment is disease progression, or disease recurrence or progression within 3 months after the end of the platinum-based treatment.

History of other malignancies within 5 years prior to enrollment, excluding cured skin basal cell carcinoma, cervical carcinoma in situ, or papillary thyroid carcinoma.

Anti-tumor therapy, including chemotherapy, radiotherapy, target therapy, immunotherapy, etc. within 4 weeks prior to the first dose of the investigational drug, except for the following items;

Received nitrosourea or mitomycin C within 6 weeks prior to the first dose of the investigational drug;

Trial design

Treatments tested in this trial

  • Utidelone capsule 75mg/m2/d QD
  • Utidelone capsule 40mg/m2/d BID
  • Utidelone capsule 50mg/m2/d BID
  • Utidelone capsule 35mg/m2/d BID

Treatment groups

72 Participants
are divided into 4 treatment groups

Locations

This trial has no locations