Calendario›HALO›PRIMAL

PRIMAL

A Phase 1b Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined With Docetaxel in Subjects With Recurrent Previously Treated Locally Advanced or Metastatic NSCLC

Ensayo de HALOZYME THERAPEUTICS, INC. en Cancer de pulmon no microcitico.

Más ensayos de: Cáncer de pulmón no microcítico.

Fase

Fase 1

Estado

Interrumpido

Participantes

16

previstos

Centros

8

Fin del objetivo primario

ago 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, abierto. Comenzó en feb 2015.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Changing standard of care therapy regimen».

Qué mide

Number of Dose Limiting Toxicities (DLTs) (Cycle 1 (Day 1 through Day 21) (1 Cycle = 21 days)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroA Phase 1b study for participants with Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) to participate in 1 of 2 portions of this study. The first portion is Dose Escalation in which participants are tested with PEGPH20 at various doses (1.6, 3.0, 2.2 and 2.8 micrograms/kilogram (ug/kg)) in addition to dosing with the standard dose of docetaxel (PDoc) of 75 milligrams/meter squared (mg/m\^2) once every 21-day cycle. Based on observations on the safety and tolerability of study treatment from dose escalation cohorts dosed to date (1.6 and 3.0 ug/kg of PEGPH20), two additional dose levels will be tested, 2.2 and 2.8 ug/kg. Up to 30 additional participants may be enrolled to test these dose levels. The second portion of Phase 1b is Cohort Expansion in which the recommended Phase 2 dose (RP2D) of PDoc identified in dose escalation is administered every 21 days to approximately 50 participants with high hyaluronan (HA-high) prospectively measured in their tumor tissue.

Más ensayos de HALO

Todos los de HALO, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02346370), actualizada en feb 2019.