Идёт набор NCT07213804

A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer

Фаза III С лечением Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms Neoplasm Metastasis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine.
Кому может быть актуально: Состояния в реестре: Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Neoplasm Metastasis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Австралия, Австрия, Бельгия, Бразилия +21
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

FRAmework-01: A Three-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer.

Обзор

This is a clinical study that has three parts. It is testing a potential new medicine called Sofetabart Mipitecan (Sofe-M) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A enrolls participants with platinum-resistant cancer, meaning their disease progressed during or within six months of platinum-based chemotherapy. Parts B and C enroll participants with platinum-sensitive cancer, whose disease responded and remained controlled for at least six months after completing platinum treatment. The researchers want to find out if Sofe-M works better than the standard treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.

Вмешательства

Препарат Sofetabart Mipitecan
Administered IV
Препарат Paclitaxel
Administered IV
Препарат Topotecan
Administered IV
Препарат Gemcitabine
Administered IV
Препарат Pegylated liposomal doxorubicin (PLD)
Administered IV
Препарат MIRV
Administered IV
Препарат Bevacizumab
Administered IV
Препарат Carboplatin
Administered IV

Первичные конечные точки

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator [Срок оценки: Randomization to radiographic progression or death from any cause (up to 70 months)]
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded, Independent, Central Review (BICR) [Срок оценки: Randomization to radiographic progression or death from any cause (up to 70 months)]

Вторичные конечные точки (12)

Overall Survival (OS) [Срок оценки: Randomization to date of death from any cause (up to 70 months)]
PFS [Срок оценки: Randomization to radiographic progression or death from any cause (up to 70 months)]
Overall Response Rate (ORR): Proportion of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) [Срок оценки: Randomization to disease progression or death (up to 70 months)]
Duration of Response (DOR) [Срок оценки: Date of first documented CR or PR to date of radiographic progression or death from any cause (up to 70 months)]
Disease Control Rate (DCR): Proportion of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD) [Срок оценки: Randomization to disease progression or death from any cause (up to 70 months)]
PFS2 [Срок оценки: Randomization to disease progression on next line of treatment or death from any cause (up to 70 months)]
Time to Initiation of First Subsequent Systemic Anticancer Therapy or Death (TNTD) [Срок оценки: Randomization to initiation of subsequent systemic anticancer or death from any cause (up to 70 months)]
Proportion of Participants with Response of Cancer Antigen-125 (CA-125) per Gynecologic Cancer Intergroup Criteria (GCIG) [Срок оценки: Randomization to 30 days post treatment discontinuation]
Percentage of Assessments with High Side-effect Bother, as measured by Functional Assessment of Cancer Therapy - General Item 5 (FACT GP5) [Срок оценки: Randomization to 30 days post treatment discontinuation]
Change from Baseline in Abdominal/GI Symptoms, as measured by the European Organization for Research and Treatment of Cancer Ovarian Cancer Module (EORTC OV28) [Срок оценки: Randomization to 30 days post treatment discontinuation]
Change from Baseline in Overall Health-related Quality of Life (HRQoL), as measured by the EORTC QLQ-C30 Global Health Status/Quality of Life Subscale [Срок оценки: Randomization to 30 days post treatment discontinuation]
Pharmacokinetics (PK): Minimum Blood Plasma Concentration (Cmin) of LY4170156 [Срок оценки: Randomization through end of treatment (up to 70 months)]]

Критерии участия

Критерии включения

Part A, B, and C:

Have histologically confirmed high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
Have confirmed availability of tumor tissue block or slides
Have radiographic progression on or after most recent line of systemic anticancer therapy
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Have measurable disease per RECIST v1.1

Part A:

Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy.
Have previously received 1 to 3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior cytotoxic therapy is allowed if one of those lines is mirvetuximab soravtansine.
Have received prior bevacizumab treatment, unless documented contraindication or intolerance.
Have received treatment with a poly (ADP-ribose) polymerase inhibitor (PARPi) if known to have a somatic or germline breast cancer gene (BRCA) mutation, if clinically indicated, unless documented contraindication or intolerance.

Part B and C:

Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (>)6 months of their last administration of platinum therapy
Have previously received 1 to 2 prior lines of systemic cytotoxic chemotherapy

Part B:

\- Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment.

Part C:

\- Have not previously received a PARPi treatment.

Критерии исключения

Parts A, B and C:

\- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload.

Part A:

Have primary platinum-refractory disease, defined as radiographic progression ≤ 1 month since the last dose of first-line platinum-containing chemotherapy.

Part B and C:

\- Have clinically significant proteinuria

Part C:

\- Have a known pathogenic BRCA1/2 gene alteration (somatic or germline).

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: Открытое
Основная цель: Лечение