A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.

Официальное название

A Multicenter, Randomized, Double-blind, Parallel-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of B013 Combined With Paclitaxel in the Treatment of Platinum-resistant Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer.

Обзор

To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.

Вмешательства

• Препарат B013
  B013: The subjects will receive IV dose of B013 600 mg on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
• Препарат Paclitaxel
  Paclitaxel: 80 mg/m\^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle.
• Препарат Placebo
  Placebo: The subjects will receive IV dose of placebo matched to B013 on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.

Первичные конечные точки

• Progression-free survival (PFS) [Срок оценки: Approximately 2 years]

Вторичные конечные точки (5)

• Objective response rate (ORR) [Срок оценки: Approximately 2 years]
• Disease control rate (DCR) [Срок оценки: Approximately 2 years]
• Duration of remission (DOR) [Срок оценки: Approximately 5 years]
• Overall Survival (OS) [Срок оценки: Approximately 2 years]
• Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Срок оценки: Approximately 5 years]

Критерии участия

Критерии включения

• Subjects who voluntarily participate in this study and sign informed consent form;
• Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum resistance recurrence;
• ECOG performance status of 0 or 1；
• Expected survival > 12 weeks;
• The subject has at least one measurable lesion;
• Normal function of major organs;
• The fertile subjects agree to use reliable contraception from signing the informed consent to at least 6 months after the last dose.

Критерии исключения

• Subjects who have received prescribed treatment previously;
• Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;
• Subjects with known central nervous system metastasis and multiple bone metastasis;
• Subjects who had clinical symptoms of pleural effusion, pericardial effusion or ascites before randomization and needed puncture drainage, or had received puncture drainage within the previous 2 weeks;
• Have a history of other malignant tumors within 5 years before signing the informed consent;
• Subjects with prescribed cardiovascular diseases;
• Subjects with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization;
• Had severe lung disease before randomization;
• Before randomization, the peripheral nerve toxicity of previous anti-tumor treatment was > grade 2, and other reversible toxicity was > grade 1;
• Subjects who had undergone surgery within 28 days prior to randomization and did not recover from adverse effects of surgery;
• Subjects who participated in clinical trials within 30 days prior to randomization and received other unmarketed investigational drugs;
• Subjects who are known to be allergic to any component of B013 or paclitaxel.
• Subjects with a known history of substance abuse, alcohol or drug use; Subjects with a known history of neurological or psychiatric disorders;
• Female subjects who are pregnant or breastfeeding;
• Other situations determined by the researchers and/or sponsors as unsuitable for participation in this trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 17 центров

• Beijing Cancer Hospital — Пекин
• The First Affiliated Hospital of Bengbu Medical University — Bengbu
• XiangYa Hospital CentralSouth University — Чанша
• Fujian Cancer Hospital — Фучжоу
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Гуанчжоу
• Cancer Hospital of Shandong First Medical University — Цзинань
• Qilu Hospital of Shandong University — Цзинань
• Yunnan Cancer Hospital — Куньмин
• … и ещё 9 центров

Идентификаторы

NCT: NCT06434610 · SPH-B013-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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