Calendario›INCY›ruxolitinib
ruxolitinib
An Open-Label Study of Ruxolitinib Given With Chemotherapy in Patients With Advanced Solid Tumors
Ensayo de INCYTE CORP en Tumor solido · Cancer de pancreas.
Más ensayos de: Tumor sólido · Cáncer de páncreas.
- Fase
- Fase 1
- Estado
- Interrumpido
- Participantes
- 42
- Centros
- 5
- Fin del objetivo primario
- sep 2015
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en abr 2013.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Dose escalation ended after Cohort B1, RUX 10 mg BID - GCSF in October 2014.».
Qué mide
Percentage of Participants With Adverse Events That Are Defined as Dose Limiting Toxicities (DLTs) (del registro, en inglés) (unos 28 dias)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a study of ruxolitinib in combination with gemcitabine with or without nab-paclitaxel administered to patients with advanced or metastatic pancreatic cancer. The study will be conducted in two parts. Part 1 of the study will evaluate the safety, tolerability and pharmacokinetics (PK) of ruxolitinib when given as described to patients with advanced or metastatic pancreatic cancer. A goal of Part 1 will be to identify the maximally tolerated dose (MTD) of ruxolitinib when given with gemcitabine with or without nab-paclitaxel. This dose will be selected for use in Part 2 of the study. Part 2 of the study will further evaluate the safety, tolerability, PK and preliminary clinical activity of ruxolitinib at the dose defined in Part 1 used in combination with gemcitabine with or without nab-paclitaxel in subjects with advanced or metastatic pancreatic cancer. After multiple challenges of trial conduct, by mutual agreement between investigators and sponsor, dose escalation ended after Cohort B1, RUX 10 mg twice daily (BID) - GCSF in October 2014. Therefore, the MTD was not reached. No safety issues led to the decision to stop further enrollment. Because of the early study termination, samples for pharmacokinetics and pharmacodynamics, and computed tomography for tumor burden were collected, but not analyzed; analysis data are not available. The data cutoff for this posting is 22 SEP 2015. As of the data cutoff, 1 subject was receiving treatment in the study and had been enrolled for 47 weeks. This subject had their end of treatment visit in AUG 2016. A comparison of this subjects' safety data after the cutoff date showed no clinically meaningful differences (eg, adverse events) compared with safety results that are summarized here.
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Todos los de INCY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01822756), actualizada en ene 2018.