Patrocinado por: Hoffmann-La Roche
Status de recrutamento
Faixa etária
Sexo
Fase do estudo
TAPISTRY é um estudo de Fase II, global, multicêntrico, aberto e multicoorte projetado para avaliar a segurança e a eficácia de terapias direcionadas ou imunoterapia como agentes únicos ou em combinações racionais especificadas em participantes com tumores sólidos irressecáveis, localmente avançados ou metastáticos determinados a abrigar alterações genômicas oncogênicas específicas ou que têm alta carga mutacional tumoral (TMB), conforme identificado por um ensaio validado de sequenciamento de próxima geração (NGS).
Os participantes com tumores sólidos serão tratados com um medicamento ou regime medicamentoso adaptado aos resultados do ensaio NGS na triagem. Os participantes serão designados para a coorte apropriada com base em sua(s) alteração(ões) genética(s). O tratamento será atribuído com base no oncogenótipo relevante, terá critérios de inclusão/exclusão específicos de coorte e, a menos que especificado de outra forma, continuará até a progressão da doença, perda de benefício clínico, toxicidade inaceitável, decisão do participante ou do médico de descontinuar ou morte , o que quer que ocorra primeiro.
Mais detalhes...Critérios de inclusão:
Critérios de Exclusão:
Adults and pediatric participants with a BSA >/= 1.51 m2: entrectinib will be self-administered by participants orally at home at a dose of 600 mg/day (three 200-mg capsules per day). Pediatric participants with a BSA < 1.51 m2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m2) or 300 mg/day (BSA=0.81-1.10 m2) or 200 mg/day (BSA=0.51-0.80 m2) or 100 mg/day (BSA=0.43-0.50 m2).
Alectinib will be administered orally BID (twice a day) with food at a dosage of 600 mg (four 150-mg capsules).
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg for participants aged >/=18 years, and 15 mg/kg (maximum 1200 mg) for participants aged <18 years on Day 1 of each 21-day cycle.
For participants 12-17 years of age, ipatasertib will be administered at the starting dose of 200 mg for participants < 35 kg, 300 mg for participants >/= 35 and < 45 kg, 400 mg for those >/= 45 kg orally QD, beginning of Cycle 1, on Days 1-21 of each 28-day cycle until the participant experiences disease progression, intolerable toxicity, or withdraws consent.
Trastuzumab emtansine will be administered at 3.6 mg/kg by IV infusion every 21 days until disease progression or unacceptable toxicity. The dosage and administration method also applies for pediatric participants 12-17 years of age.
Idasanutlin will be administered at 250 mg QD (daily) PO for Days 1-5 of each 28-day cycle. Idasanutlin may be given without regard to meals and water can be given as often as necessary or desired. The daily doses should be administered 10-14 hours apart. Note: Cohort G has been closed for enrollment.
GDC-077 will be administered QD at a starting dose of 9 mg PO in repeated 28-day cycles. The dosage and administration method also applies for pediatric participants 12-17 years of age.
Belvarafenib will be administered at a dose 400 mg (PO) BID with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle.
Pralsetinib will be self-administered by participants orally at home (except on clinic days) on a continuous daily dosing regimen at a dose of 400 mg/day (four 100-mg capsules per day) for adult and pediatric patients ≥ 12 and < 18 years of age. A treatment cycle consists of 4 weeks (28 days).
GDC-6036 will be self-administered by patients orally at home (except on clinic days) on a continuous daily dosing regimen for both adult and pediatric patients. A treatment cycle consists of 3 weeks (21 days).
Camonsertib will be self-administered by patients orally at home (except on clinic days). A treatment cycle consists of 3 weeks and will be given on days 1-3 and days 8-10 of every 21-day cycle.
Conheça outros estudos que podem ser do seu interesse:
Motsa