Идёт набор NCT07265947

Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma

Фаза II С лечением Low Grade Upper Tract Urothelial Carcinoma

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: Dabogratinib (TYRA-300) 60mg, Dabogratinib (TYRA-300) 80mg, Dabogratinib (TYRA-300) TBD.
Кому может быть актуально: Состояния в реестре: Low Grade Upper Tract Urothelial Carcinoma. 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, Испания
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

A Phase 2A/B, Multi-center, Open-Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants With Low Grade Upper Tract Urothelial Carcinoma (SURF303)

Обзор

A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma

Подробное описание

A Phase 2A/B, Multi-center, Open-Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants with Low Grade Upper Tract Urothelial Carcinoma (SURF303)

Вмешательства

Препарат Dabogratinib (TYRA-300) 60mg
Self-administered 60mg dose Oral tablet(s) given daily
Препарат Dabogratinib (TYRA-300) 80mg
Self-administered 80mg dose Oral tablet(s) given daily
Препарат Dabogratinib (TYRA-300) TBD
To be determined: Self-administered Oral tablet(s) given daily

Первичные конечные точки

To assess the efficacy of Dabogratinib in LG UTUC FGFR3+ participants (proportion of participants with a CR within 6 months out of all LG UTUC FGFR3+ participants) [Срок оценки: within 6 months]

Вторичные конечные точки (6)

To assess the efficacy of Dabogratinib in LG UTUC in all participants (proportion of participants with a CR within 6 months out of all LG UTUC participants) [Срок оценки: at 6 months]
Duration of Response (DOR)(median time for CR duration in those participants who achieve a CR) [Срок оценки: up to 36 months]
Complete Response (proportion of participants who continue to have a CR at 12 and 24 months) [Срок оценки: at 12 and 24 months]
Safety and tolerability of dabogratinib [Срок оценки: Up to 2 years]
Rate of renal preservation after treatment with dabogratinib [Срок оценки: Up to 2 years]
Change from unresectable UTUC to resectable UTUC [Срок оценки: Up to 2 years]

Критерии участия

Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures
Confirmed LOW RISK LG UTUC (both favorable and unfavorable) per AUA
At least 5mm of marker lesion left behind
Participants must have previous genomic report or archival/fresh tissue in addition to urine sample for retrospective genomic testing
Identification of marker lesion(s) within 8 weeks prior to randomization (refer to Inclusion Criterion #2)
If synchronous NMIBC, NMIBC must be fully resected and low-grade Ta or T1
No prior BCG administration within 1 year of date of consent.
No intravesical chemotherapy within 8 weeks prior to C1D1 (including UGN-101).
No systemic chemotherapy within 3 months prior to C1D1
ECOG 0-2
Pathology consists of pure urothelial carcinoma
Adequate bone marrow, liver, and renal function:

i. Absolute neutrophil count (ANC) ≥1,500/mm3 ii. Platelet count ≥75,000/mm3 iii. Hemoglobin ≥10.0 g/dL
i. Total bilirubin ≤ ULN ii. Alanine aminotransferase (ALT) ≤ ULN iii. Aspartate aminotransferase (AST) ≤ ULN
Estimated glomerular filtration rate >60 mL/min
Serum Phosphate level ≤ ULN prior to starting treatment
International normalized ratio (INR) ≤1.5 × ULN

Критерии исключения

Evidence or any features of high grade (HG) UTUC
History of carcinoma in situ (CIS)
History of prostatic urethral involvement
Current or previous history of muscle invasive bladder cancer
Current or previous history of lymph node positive and/or metastatic bladder cancer
Evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma or small cell of the bladder
Currently receiving systemic cancer therapy (cytotoxic or immunotherapy)
Current or prior history of pelvic external beam radiotherapy for bladder cancer
Current or history of receiving a prior FGFR inhibitor
Systemic immunotherapy within 6 months prior to randomization
Treatment with an investigational agent within 30 days or 5 half-lives from randomization, whichever is shorter; compounds with an unknown half-life will be default to 30 days.
Prior treatment with an intravesical or intracavitary agent within 8 weeks of C1D1.
Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination.
Requiring use of medications that are potential inhibitors or inducers of CYP3A (prohibited list of medications)

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

Здоровые добровольцы: Нет