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

ConditionsOvarian CancerFallopian Tube CancerPrimary 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

72 Participants
are divided into 4 treatment groups
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2 initial groupExperimental treatment 1 intervention
Group C: Cohort 2 escalation groupExperimental treatment 1 intervention
Group D: Cohort 2 de-escalation groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

The incidence of adverse events (AE)/serious adverse events (SAE)

Time frame
Until 28 days after the last dose of treatment

Secondary outcomes

1

Objective response rate (ORR)

based on RECIST v1.1

Time frame
18 months
2

Disease control rate (DCR)

Time frame
18 months
3

Progression-free survival (PFS)

Time frame
18 months
4

Maximum (or peak) serum concentration-Cmax

Time frame
18 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Biostar Pharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: