Calendario›HALO›PEGPH20
PEGPH20
PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer
Ensayo de HALOZYME THERAPEUTICS, INC. en Metastatic Pancreatic Cancer (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 279
- Centros
- 51
- Fin del objetivo primario
- may 2018
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en may 2013.
Qué mide
Progression-Free Survival (PFS) (From the date of randomization until disease progression or death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study is designed to compare the treatment effect of PEGPH20 combined with nab-paclitaxel (NAB) and gemcitabine (GEM) \[PAG\] to NAB and GEM \[AG\] in participants with Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). The study will have 2 run-in phases, one for each formulation of PEGPH20 (original and new formulations), and a Phase 2 portion. The 2 run-in phases will evaluate the safety and tolerability of the PAG treatment using the original and new succinic acid PEGPH20 formulation, respectively, compared with AG treatment. Phase 2 will have 2 stages due to a partial clinical hold that occurred from April through July 2014. The participants will be randomized in 3:1 for the run-in phases. The first stage will randomize participants in a 1:1 ratio. The second stage will randomize participants in a 2:1 ratio (PAG:AG). This is an open-label study. To minimize bias to the progression-free survival endpoint, disease progression will be based on the assessment of the Central Imaging Reader (CIR). Determination of clinical progression by the Investigator without corresponding CIR confirmation will be documented with the relevant signs and symptoms.
Más ensayos de HALO
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Testosterone enanthate | Fase 3 | Reclutando pacientes | mar 2028 (prevista) |
| PEGPH20 | Fase 1 | Interrumpido | nov 2019 (real) |
| nab-Paclitaxel | Fase 3 | Interrumpido | nov 2019 (real) |
| PEGPH20 | Fase 1 | Completado | mar 2019 (real) |
| PRIMAL | Fase 1 | Interrumpido | ago 2016 (real) |
| HALO-117-406 | Fase 4 | Completado | feb 2014 (real) |
Todos los de HALO, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01839487), actualizada en jul 2020.