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Aroplatin

Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell Lymphoma

Ensayo de AGENUS INC en Neoplasias malignas · Linfoma de celulas B.

Más ensayos de: Linfoma de células B.

Fase

Fase 1

Estado

Completado

Participantes

21

previstos

Centros

2

Fin del objetivo primario

jun 2008

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en mar 2006.

Qué mide

Determinar la dosis maxima tolerada y la toxicidad limitante de dosis de L-NDDP

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a dose escalation study. Patients will be enrolled in cohorts of three patients each, and escalation of dose to the next cohort will be determined based on dose-limiting toxicity (DLT) in the previous cohort. This study aims to identify the maximum tolerated dose (MTD) of intravenous L-NDDP. Once the MTD has been determined, an additional four patients will be enrolled at that dose level. While the MTD is determined based on safety data from each cohort's first cycle of L-NDDP therapy only, patients may continue treatment with additional cycles of L-NDDP at the same dose as their starting dose until documented progression, unacceptable toxicity, or another off study criterion is met. Patients who have not met any of the off study criteria and continue to receive L-NDDP therapy at the time when MTD is determined may be allowed to change L-NDDP dose to the MTD dose level. The study will also determine the pharmacokinetic profile of L-NDDP administration. Clinical activity of L-NDDP in solid tumor patients will be assessed as tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Clinical activity of L-NDDP in B-cell lymphoma patients will be assessed using the International Working Group recommendations.

Más ensayos de AGEN

Todos los de AGEN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00316511), actualizada en oct 2008.