drugset / Trial / NCT00389480

Study of AR-67 (Formerly DB-67) in Adult Patients With Refractory or Metastatic Solid Malignancies

NCT00389480 ↗

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Hypothesis: AR-67 (formerly DB-67) represents a rationally engineered drug that possesses improved stability, toxicity, and efficacy compared to current Food and Drug Administration (FDA)-approved camptothecins, based on the extensive research of prior studies. Therefore, the investigators hypothesize that AR-67 (formerly DB-67) will be well-tolerated and efficacious in phase I clinical trials. This initial phase I trial will establish the maximum tolerated dose in humans, establish the toxicity profile, and define the appropriate dose of AR-67 (formerly DB-67) for future phase II and III clinical trials.

Timeline

Start
2006-10
Primary completion
2009-02
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Subject AR-67 Small molecule — Intravenous

Indications