drugset / Trial / NCT00389480
Study of AR-67 (Formerly DB-67) in Adult Patients With Refractory or Metastatic Solid Malignancies
Phase 1
Completed
26 enrolled
Arno Therapeutics
Arch Medical Services Inc., DBA The Center for Cancer Care and Research · collabUniversity of Kentucky · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AR-67 | Small molecule | — | Intravenous |