drugset / Trial / NCT01505608

Randomized Efficacy Study of TPI 287 to Treat Primary Refractory or Early Relapsed Neuroblastoma

NCT01505608

Phase 1/2 Terminated 14 enrolled Giselle Sholler Cortice Biosciences, Inc. · collab
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this research study is to evaluate a new investigational drug (TPI 287) for early relapsed neuroblastoma. An investigational drug is one that has not yet been approved by the Food and Drug Administration. This investigational drug is called TPI 287. This study will look at the tumor's response to the study drug, TPI 287, in combination with Irinotecan and Temozolomide versus the combination of Irinotecan and Temozolomide alone. This study will also evaluate the safety and tolerability of the study drug, TPI 287.

Timeline

Start
2011-12
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject TPI 287 Small molecule 125 mg/m2 Intravenous
Background Irinotecan Small molecule 10 mg/m2 Intravenous
Background Temozolomide Small molecule 100 mg/m2 Oral

Indications