drugset / Trial / NCT00710125

Safety Study of GPX-150 in Patients With Solid Tumors

NCT00710125 ↗

Phase 1 Completed 27 enrolled Gem Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 1 safety and dose escalation study to define the maximum tolerated dose (MTD) and identify the dose limiting toxicities (DLT) following IV administration of GPX-150 once every 3 weeks. Escalating doses starting at the dose of 14 mg/m2 and increasing to the dose of 265 mg/m2 will be administered IV once every 3 weeks for up to 8 cycles of treatment. Patients who have previously received an anthracycline are limited to 4 cycles of treatment.

Timeline

Start
2008-01
Primary completion
2013-10
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Camsirubicin Small molecule 14 mg/m2 Intravenous
Subject Camsirubicin Small molecule 265 mg/m2 Intravenous

Indications

No indication recorded.